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NCT Number: NCT05812157

Optimizing Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17

Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in only a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. These SCFAs can restore the intestinal barrier and promote certain anti-inflammatory cells, including regulatory T cells (Tregs), which are essential to the mechanisms in tolerance of the self. Fibers could therefore correct the intestinal abnormalities present in patients with axial spondyloarthritis (AxSpA) and aggravated by anti-IL-17 drugs and thus improve the therapeutic response to these treatments.

The hypothesis is that dietary fiber will correct the dysbiosis in AxSpA patients and increase the release of SCFAs, which favorably modulate the immune response and improve AxSpA.

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Key information

Conditions

Axial Spondyloarthritis Ankylosis Arthritis Bone Diseases Dysbiosis Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nîmes University Hospital, Nîmes, Gard, France

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About this study

Axial spondyloarthritis (AxSpA) is the second most common chronic inflammatory rheumatic disease, which develops preferentially in young subjects and results in a significant impairment of quality of life, particularly due to painful symptoms. The importance of the digestive system has long been recognized, since this disease is considered to be part of a larger group of diseases including Crohn's disease and ulcerative colitis because of their frequent association in the same patient, and because leaky gut disorders and alterations of the intestinal microbiota (dysbiosis) have been described in these patients. These abnormalities may stimulate the immune system and therefore be involved in inflammatory processes (especially Th17). The available treatments are based on non-steroidal anti-inflammatory drugs, and in the event of failure or intolerance, biomedicines targeting TNF can be used. Therapeutic monoclonal antibodies against IL-17 have recently enriched the therapeutic arsenal. Although most anti-TNF agents have a beneficial effect on the rheumatologic and digestive aspects of these diseases, anti-IL-17 agents are not expected to be effective in inflammatory bowel diseases.

Indeed, a deleterious role of anti-IL-17 on the intestinal microbiota has even been demonstrated, which could result in a reduction of the systemic anti-inflammatory effect expected from these molecules, and consequently of the clinical benefit felt by the patient. In fact, anti-IL-17s lead to a significant decrease in Clostridiales, bacteria that participate in intestinal homeostasis.

Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in just a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. These SCFAs can restore the intestinal barrier and promote certain anti-inflammatory cells, including regulatory T cells (Tregs), which are essential to the mechanisms in tolerance of the self. Fibers could therefore correct the intestinal abnormalities present in AxSpA patients and aggravated by anti-IL-17 drugs and thus improve the therapeutic response to these treatments.

The hypothesis is therefore that dietary fiber will correct the dysbiosis in AxSpA patients and increase the release of SCFAs, which favorably modulate the immune response and thus improve AxSpA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with spondyloarthritis meeting the ASAS criteria
  • Patient considered by the treating rheumatologist for anti-IL-17 biomedication
  • Patients aged between 18 and 90 years of age
  • Patients who are affiliated to a French social security system or beneficiaries of such a system
  • Patients with no desire to become pregnant during the study period (Effective contraception for women of childbearing age during the study period (surgical sterilization, hormonal contraceptives, barrier method, intrauterine device))

Exclusion criteria

  • Lack of written informed consent after a time of reflection
  • Patients participating in other therapeutic research or having participated in research for which the exclusion period has not ended
  • Patient under court protection, guardianship or curatorship.
  • Patient unable to give consent.
  • Pregnant or breastfeeding woman
  • Patients with digestive disorders for which a chronic inflammatory bowel disease has not been excluded
  • Patients with fructose intolerance or glucose or galactose malabsorption
  • Patients with known intolerance to inulin or maltodextrin

Treatment and study plan

Daily dietary supplementation with Fibruline

Dietary Supplement

Supplementation with 12 grams per day of Fibruline reconstituted with 60mL of water, once a day

Anti-IL-17 therapy

Drug

Patients in both groups will be on anti-IL-17 therapy

Primary outcomes

  1. Clostridial changes in the Experimental group

    Time frame: Week 0

    Patients will receive fiber supplementation with inulin (Fibruline® Instant, Fagron laboratory) at a rate of 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. To confirm the efficacy of treatment, the percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.

  2. Clostridial changes in Controls

    Time frame: Week 0

    Patients will receive a placebo consisting of Maltodextrin (Fagron laboratories), packaged in jars identical to those used for inulin, with a volumetric equivalent, an energy contribution and very similar color. Patients will consume 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. The percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.

  3. Clostridial changes in the Experimental group

    Time frame: Week 12

    Patients will receive fiber supplementation with inulin (Fibruline® Instant, Fagron laboratory) at a rate of 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. To confirm the efficacy of treatment, the percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.

  4. Clostridial changes in Controls

    Time frame: Week 12

    Patients will receive a placebo consisting of Maltodextrin (Fagron laboratories), packaged in jars identical to those used for inulin, with a volumetric equivalent, an energy contribution and very similar color. Patients will consume 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. The percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.

Secondary outcomes

  1. Effect of fiber supplementation on clinical therapeutic response in the experimental group: Delta BASDAI

    Time frame: Week 0

    Clinical response rates observed in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.

    The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.

  2. Effect of fiber supplementation on clinical therapeutic response in the experimental group: Delta BASDAI

    Time frame: Week 12

    Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.

    The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.

  3. Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS20

    Time frame: Week 0

    Clinical response rates observed in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.

    The ASAS20 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).

  4. Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS20

    Time frame: Week 12

    Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.

    The ASAS20 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).

  5. Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS40

    Time frame: Week 0

    Clinical response rates observed in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.

    The ASAS40 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).

  6. Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS40

    Time frame: Week 12

    Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.

    The ASAS40 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).

  7. Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASDAS

    Time frame: Week 0

    Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.

    The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).

  8. Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASDAS

    Time frame: Week 12

    Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.

    The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).

  9. Effect of fiber supplementation on clinical therapeutic response: GIQLI

    Time frame: Week 0

    Clinical response rates in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.

    Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.

  10. Effect of fiber supplmentation on clinical therapeutic response: GIQLI

    Time frame: Week 12

    Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.

    Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.

  11. Effect at 12 weeks of placebo on clinical therapeutic response: Delta BASDAI

    Time frame: Week 0

    Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.

    The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.

  12. Effect at 12 weeks of placebo on clinical therapeutic response: Delta BASDAI

    Time frame: Week 12

    Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.

    The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.

  13. Effect at 12 weeks of placebo on clinical therapeutic response: ASA20

    Time frame: Week 0

    Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.

    The ASAS20 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).

  14. Effect at 12 weeks of placebo on clinical therapeutic response: ASA20

    Time frame: Week 12

    Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.

    The ASAS20 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).

  15. Effect at 12 weeks of placebo on clinical therapeutic response: ASA40

    Time frame: Week 0

    Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.

    The ASAS40 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).

  16. Effect at 12 weeks of placebo on clinical therapeutic response: ASA40

    Time frame: Week 12

    Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.

    The ASAS40 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).

  17. Effect at 12 weeks of placebo on clinical therapeutic response: ASDAS

    Time frame: Week 0

    Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).

  18. Effect at 12 weeks of placebo on clinical therapeutic response: ASDAS

    Time frame: Week 12

    Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).

  19. Effect of placebo on clinical therapeutic response: GIQLI

    Time frame: Week 0

    Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.

    Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.

  20. Effect of placebo on clinical therapeutic response: GIQLI

    Time frame: Week 12

    Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.

    Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.

  21. Tolerance of anti-IL17 intervention and treatment in the experimental group: Permeability

    Time frame: Month 0

    Changes in serum concentrations of intestinal permeability markers (zonulin, claudin-3, iFABP); and endotoxemia (LBP, CD14s) will be measured by ELISA in ng/ml

  22. Tolerance of anti-IL17 intervention and treatment in controls: Permeability

    Time frame: Month 3

    Changes in serum concentrations of intestinal permeability markers (zonulin, claudin-3, iFABP); and endotoxemia (LBP, CD14s) will be measured by ELISA in ng/ml

  23. Tolerance of anti-IL17 intervention and treatment in the experimental group

    Time frame: Month 3

    The distribution and diversity of different germs will be measured by 16S RNA sequencing.

    Quantitative

  24. Tolerance of anti-IL17 intervention and treatment in controls

    Time frame: Month 3

    The distribution and diversity of different germs will be measured by 16S RNA sequencing.

    Quantitative

  25. Presence of candida in patients in the experimental group

    Time frame: Month 3

    YES/NO

  26. Presence of candida in patients in the control group

    Time frame: Month 3

    YES/NO

  27. Tolerance of treatment in the experimental group

    Time frame: Month 3

    All adverse events related or not to anti-IL17 treatment and potentially associated with the consumption of high doses of fiber (bloating, flatulence, diarrhea, abdominal pain) will be recorded

  28. Tolerance of treatment in the control group

    Time frame: Month 3

    All adverse events related or not to anti-IL17 treatment and potentially associated with the consumption of high doses of fiber (bloating, flatulence, diarrhea, abdominal pain) will be recorded

  29. Complete blood count: Red blood cells in the experimental group

    Time frame: Month 0

    Red blood cells will be measured in millions/mm3

  30. Complete blood count: Red blood cells in the control group

    Time frame: Month 0

    Red blood cells will be measured in millions/mm3

  31. Complete blood count: Red blood cells in the experimental group

    Time frame: Month 3

    Red blood cells will be measured in millions/mm3

  32. Complete blood count: Red blood cells in the control group

    Time frame: Month 3

    Red blood cells will be measured in millions/mm3

  33. Complete blood count: White blood cells in the experimental group

    Time frame: Month 0

    White blood cells will be measured in millions/mm3

  34. Complete blood count: White blood cells in the control group

    Time frame: Month 0

    White blood cells will be measured in millions/mm3

  35. Complete blood count: White blood cells in the experimental group

    Time frame: Month 3

    White blood cells will be measured in millions/mm3

  36. Complete blood count: White blood cells in the control group

    Time frame: Month 3

    White blood cells will be measured in millions/mm3

  37. Complete blood count: Hemoglobin in the experimental group

    Time frame: Month 0

    Hemoglobin will be measured in g/L

  38. Complete blood count: Hemoglobin in the control group

    Time frame: Month 0

    Hemoglobin will be measured in g/L

  39. Complete blood count: Hemoglobin in the experimental group

    Time frame: Month 3

    Hemoglobin will be measured in g/L

  40. Complete blood count: Hemoglobin in the control group

    Time frame: Month 3

    Hemoglobin will be measured in g/L

  41. Complete blood count: Hematocrit in the experimental group

    Time frame: Month 0

    Hematocrit will be measured as a % of whole blood

  42. Complete blood count: Hematocrit in the control group

    Time frame: Month 0

    Hematocrit will be measured as a % of whole blood

  43. Complete blood count: Hematocrit in the experimental group

    Time frame: Month 3

    Hematocrit will be measured as a % of whole blood

  44. Complete blood count: Hematocrit in the control group

    Time frame: Month 3

    Hematocrit will be measured as a % of whole blood

  45. Complete blood count: Platelets in the experimental group

    Time frame: Month 0

    Platelets will be measured in K/µL

  46. Complete blood count: Platelets in the control group

    Time frame: Month 0

    Platelets will be measured in K/µL

  47. Complete blood count: Platelets in the experimental group

    Time frame: Month 3

    Platelets will be measured in K/µL

  48. Complete blood count: Platelets in the control group

    Time frame: Month 3

    Platelets will be measured in K/µL

  49. T-lymphocytes in the experimental group

    Time frame: Month 0

    The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells

  50. T-lymphocytes in the control group

    Time frame: Month 0

    The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells

  51. T-lymphocytes in the experimental group

    Time frame: Month 3

    The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells

  52. T-lymphocytes in the control group

    Time frame: Month 3

    The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells

  53. Monocytes in the experimental group

    Time frame: Month 0

    Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells

  54. Monocytes in the control group

    Time frame: Month 0

    Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells

  55. Monocytes in the experimental group

    Time frame: Month 3

    Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells

  56. Monocytes in the control group

    Time frame: Month 3

    Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells

  57. Aspartate aminotransferase (ASAT) in the experimental group

    Time frame: Month 0

    Aspartate aminotransferase (or ASAT) will be measured in international units per liter

  58. Aspartate aminotransferase (ASAT) in the experimental group

    Time frame: Month 3

    Aspartate aminotransferase (or ASAT) will be measured in international units per liter

  59. Aspartate aminotransferase (ASAT) in the control group

    Time frame: Month 0

    Aspartate aminotransferase (or ASAT) will be measured in international units per liter

  60. Aspartate aminotransferase (ASAT) in the control group

    Time frame: Month 3

    Aspartate aminotransferase (or ASAT) will be measured in international units per liter

  61. Alanine aminotransferase (ALAT) in the experimental group

    Time frame: Month 0

    Alanine aminotransferase (ALAT) will be measured in international units per liter

  62. Alanine aminotransferase (ALAT) in the experimental group

    Time frame: Month 3

    Alanine aminotransferase (ALAT) will be measured in international units per liter

  63. Alanine aminotransferase (ALAT) in the control group

    Time frame: Month 0

    Alanine aminotransferase (ALAT) will be measured in international units per liter

  64. Alanine aminotransferase (ALAT) in the control group

    Time frame: Month 3

    Alanine aminotransferase (ALAT) will be measured in international units per liter

  65. Alkaline phosphatase in the experimental group

    Time frame: Month 0

    Alkaline phosphatase (ALP) will be measured in units per liter

  66. Alkaline phosphatase in the experimental group

    Time frame: Month 3

    Alkaline phosphatase (ALP) will be measured in units per liter

  67. Alkaline phosphatase in the control group

    Time frame: Month 0

    Alkaline phosphatase (ALP) will be measured in units per liter

  68. Alkaline phosphatase in the control group

    Time frame: Month 3

    Alkaline phosphatase (ALP) will be measured in units per liter

  69. Calcium in the experimental group

    Time frame: Month 0

    Calcium will be measured in mmol/L

  70. Calcium in the experimental group

    Time frame: Month 3

    Calcium will be measured in mmol/L

  71. Calcium in the control group

    Time frame: Month 0

    Calcium will be measured in mmol/L

  72. Calcium in the control group

    Time frame: Month 3

    Calcium will be measured in mmol/L

  73. Creatinine in the experimental group

    Time frame: Month 0

    Calcium will be measured in μmol/L

  74. Creatinine in the experimental group

    Time frame: Month 12

    Calcium will be measured in μmol/L

  75. Creatinine in the control group

    Time frame: Month 0

    Calcium will be measured in μmol/L

  76. Creatinine in the control group

    Time frame: Month 12

    Calcium will be measured in μmol/L

  77. Albumin in the experimental group

    Time frame: Month 0

    Albumin will be measured in g/liter

  78. Albumin in the experimental group

    Time frame: Month 12

    Albumin will be measured in g/liter

  79. Albumin in the control group

    Time frame: Month 0

    Albumin will be measured in g/liter

  80. Albumin in the control group

    Time frame: Month 12

    Albumin will be measured in g/liter

  81. Urea in the experimental group

    Time frame: Month 0

    Urea will be measured in mmol/L

  82. Urea in the experimental group

    Time frame: Month 12

    Urea will be measured in mmol/L

  83. Urea in the control group

    Time frame: Month 0

    Urea will be measured in mmol/L

  84. Urea in the control group

    Time frame: Month 12

    Urea will be measured in mmol/L

  85. Bilirubin in the experimental group

    Time frame: Month 0

    Bilirubin will be measured in µmol/L

  86. Bilirubin in the experimental group

    Time frame: Month 12

    Bilirubin will be measured in µmol/L

  87. Bilirubin in the control group

    Time frame: Month 0

    Bilirubin will be measured in µmol/L

  88. Bilirubin in the control group

    Time frame: Month 12

    Bilirubin will be measured in µmol/L

  89. C-Reactive Protein in the experimental group

    Time frame: Month 0

    C-Reactive Protein will be measured in mg/L

  90. C-Reactive Protein in the experimental group

    Time frame: Month 12

    C-Reactive Protein will be measured in mg/L

  91. C-Reactive Protein in the control group

    Time frame: Month 0

    C-Reactive Protein will be measured in mg/L

  92. C-Reactive Protein in the control group

    Time frame: Month 12

    C-Reactive Protein will be measured in mg/L

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Optimization of Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17

Acronym: RESPOND-IL17

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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