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Completed

NCT Number: NCT04997057

A Multistrain Probiotic in Patients With Irritable Bowel Syndrome With Predominant Constipation

Probiotics efficacy is mainly assessed by subjective endpoints such as the FDA responder rate or global relief, which partly explain contradictory results obtained in clinical trials with probiotic bacteria. Objective biomarkers of IBS will allow to measure the efficacy of probiotics. In the case of IBS-C, serum resolvin-D1 appears to be an interesting candidate due to its non-invasive and discriminating character compared to a healthy population. It is, inversely correlated with the severity of symptoms. Resolvin-D1 modulates the duration and intensity of inflammation by regulating the transcription of cytokines, chemokines and their receptors as well as other proteins involved in inflammation. Resolvin D1 could serve as a predictor of probiotic response based on its baseline value.

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Key information

Conditions

Irritable Bowel Syndrome With Constipation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEN Nutriment

Dijon, Bourgogne-Franche-Comté, 21000, France

About this study

Resolvin D1 levels will be measured in patients with IBS-C as defined by the Rome IV criteria before 6 and 12 weeks after supplementation with a mixture of probiotics. The progression of IBS-C symptoms will also be assessed throughout the study.

The correlation with resolvin D1 levels and the severity of IBS symptoms will be investigated. The efficacy of the probiotic mixture in relieving the symptoms of IBS-C will be measured and compared based on the levels of resolvin D1.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Irritable Bowel Syndrome with constipation (IBS-C) according to Rome IV criteria ;
  • IBS-SSS between 175-300 in the last 10 days ;
  • Have experienced abdominal pain ≥ 40 according to the IBS-SSS questionnaire (abdominal pain item) during the last 10 days ;
  • Whose abdominal pain / discomfort has had a significant impact on daily life during the past 10 days (impact ≥2 on a 5-point likert scale (from 0: no impact to 5: extreme impact) ;
  • Ability to understand instructions and complete questionnaires Nurstrial APP.
  • Affiliate or beneficiary of a social security ;
  • Having given their free, informed and written consent.

Exclusion criteria

  • CPRu > 10 mg/l
  • Pregnant or breastfeeding woman, woman planning a pregnancy during the study period ;
  • Intolerance or proven food allergy ;
  • BMI <18.5 kg / m2 or BMI> 35 kg / m2 ;
  • Diagnosis or known history of IBS-D, IBS-M, or unclassified forms of IBS, or other gastrointestinal pathologies ;
  • With current first-line IBS-C treatment or second-line treatment ;
  • alternative non pharmacological treatment ;
  • Drug treatment affecting visceral sensitivity or intestinal transit ;
  • dietary modification (exclusion of FODMAPs, prebiotic) or lifestyle ;
  • Excessive smoking or drinking ;
  • Having or planning bariatric surgery,
  • With known pathologies affecting gut function ;
  • With a deviant eating behavior,
  • Treated with antibiotics in the 3 months preceding inclusion,
  • Under legal protection,
  • Already included in a clinical trial,
  • With severely impaired physical/psychological health may affect study participation.

Treatment and study plan

Probiotics mixture

Dietary Supplement

12 weeks of daily supplementation with 1 g of probiotics mixture (4.10exp9 colony forming unit/g) containing:

  • Bifidobacterium longum LA 101
  • Lactobacillus helveticus La 102
  • Lactococcus lactis LA 103
  • Streptococcus thermophilus LA 104

Primary outcomes

  1. Change of the severity of IBS-C symptoms

    Time frame: At weeks 0, 4, 8 and 12

    Measured by the composite IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) system, compared to the baseline IBS-SSS value.

    Minimum : 0 (best condition) to maximum (worse condition): 500

Secondary outcomes

  1. Change of the severity of addominal pain

    Time frame: At weeks 4, 8 and 12

    Mesured by the Abdominal pain domain of the IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) score compared to the baseline.

    Minimum (best condition) : 0 to maximum (worse condition): 100

  2. Change of the number of days with abdominal pain

    Time frame: At weeks 4, 8 and 12

    Mesured by the Number of days with abdominal pain domain of the IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) score compared to the baseline.

    Minimum (best condition) : 0 to maximum (worse condition): 100

  3. Change of the severity of abdominal distension (bloating)

    Time frame: At weeks 4, 8 and 12

    Mesured by the bloating-distension domain of the IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) score compared to the baseline.

    Minimum (best condition) : 0 to maximum (worse condition): 100

  4. Change of the satisfaction with bowel habits

    Time frame: At weeks 4, 8 and 12

    Mesured by the satisfaction with bowel habits domain of the IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) score compared to the baseline.

    Minimum (best condition) : 0 to maximum (worse condition): 100

  5. Change of the IBS-related quality of life

    Time frame: At weeks 4, 8 and 12

    Mesured by the IBS related quality of life domain of the IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) score compared to the baseline.

    Minimum (best condition) : 0 to maximum (worse condition): 100

  6. Global assessment of symptoms relief

    Time frame: At weeks 4, 8 and 12

    Measured by the Subject's Global Assessment (SGA) of Relief, compared to the baseline

  7. Change of Resolvin-D1 levels

    Time frame: At weeks 8 and 12

    Blood measurement of resolvin-D1 compared to the baseline

  8. Change of CPRu (C Reactive Protein-ultrasensitive) levels

    Time frame: At weeks 8 and 12

    Blood measurement of C Reactive Protein ultrasensitive compared to the baseline

  9. Change of the intestinal microbiota

    Time frame: At weeks 6 and 12

    Biological parameter : Fecal microbiota measured by 16S rRNA gene sequencing compared to baseline

  10. Change of the stool frequency

    Time frame: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

    Patient-reported number of stools using an e-diary, compared to baseline

  11. Change of the stools consistency

    Time frame: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

    Patient-reported stools consistency by the Bristol Stool Scale, using an e-diary, compared to baseline

  12. Change of the Quality of Life

    Time frame: At weeks 4, 8 and 12

    Measured by Medical Outcomes Study Short-Form General Health Survey Short Form-12 compared to baseline

  13. Change of number of drugs consumption to alleviate the IBS-C symptoms

    Time frame: At weeks 4, 8 and 12

    Patient-reported drug (laxative, spasmolytics) consumption using an e-diary, compared to baseline

  14. Assessing the relationship between resolvin D1 levels and symptoms severity mesured by IBS-SSS symptoms scores

    Time frame: At week 12

    Regression analysis

  15. Assessing the relationship between baseline resolvin D1 levels and response to the probiotics supplementation measured by the responders rate (outcome 17)

    Time frame: At week 12

    Regression analysis

  16. Assessing the responders rate

    Time frame: At weeks 4, 8 and 12

    Number of patients with a decrease in the weekly average of worst abdominal pain in the past 24 hours score (measured daily) of at least 30 percent compared with baseline weekly average and a stool Frequency Weekly Responder is defined as a patient who experiences an increase of at least one complete stool bowel movement per week from baseline.

  17. Assessing the relationship between baseline microbiota and response to the probiotics supplementation measured by the responders rate (outcome 17)

    Time frame: At week 12

    Regression analysis

  18. Assessing the tolerance of the probiotics mixture

    Time frame: At weeks 6 and 12

    Adverse reactions analysis

  19. Assessing the global improvement

    Time frame: At weeks 4, 8 and 12

    Measured by the patient global impression of improvement

  20. Assessing the satisfaction regarding the mixture of probiotics

    Time frame: At weeks 4, 8 and 12

    Measured by a 5 points Likert scale 0 : worse satisfaction to 5 : better satisfaction

Sponsors and collaborators

Lead sponsor

CEN Biotech

Industry

Collaborators

  • PiLeJe

Registry information

Official study title

Effect of a Mixture of Probiotics (Lactibiane Reference) in Patients With Irritable Bowel Syndrome Predominantly Constipation and Assessment of a Potential Biomarker (Resolvin D1): an Exploratory Study

Acronym: EPORE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2021
Registry last updated
Dec 26, 2023

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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