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Completed

NCT Number: NCT04223479

Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan

Ulcerative colitis (UC) is a chronic Inflammatory bowel disease (IBD) that most likely results from the interaction between various environmental and genetic factors. Using probiotics as an adjunct to medical therapy might be useful in the treatment of UC and improving the symptoms of the disease. The result of studies that investigate the role of Probiotics supplementation in improving the inflammatory response, immune response and life quality of patients with the UC is not conclusive. So, this study aimed to study the effect of probiotics on the response of inflammatory markers, immune response, and quality of life in patients with UC.

An interventional double-blind randomized clinical trial (RCT) design will be used in this study. Forty patients will be recruited and randomly assigned to the placebo group (n=20) to receive 3 times a day placebo capsules; and probiotics group (n=20), to receive 3 times a day probiotic supplement. The demographic data, anthropometric measurements, IBD Quality of Life Questionnaire and blood samples will be collected at baseline and after 6 weeks of follow up. Interleukin-6, interleukin-1,interleukin-10 IL-10, C-reactive protein, tumor necrosis factor-alpha and complete blood count (CBC) will be measured.

The results will approve or disapprove the beneficial effect of using probiotics as adjuvant therapy for UC patients to raise the immune system as well as improving their quality of life.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Jordan University Hospital

Amman, Jordan

About this study

To meet the objectives of the study, an interventional double-blind randomized clinical trial (RCT) design will be used in this study. A placebo group will be included in parallel with the treatment group in this trail. Forty patients (aged 35-65 years) who diagnosed with mild to moderately active UC will be recruited conveniently from the gastroenterology section, the IBD clinic at the Jordan University Hospital, Amman, Jordan. Patients who meet the inclusion criteria and agree to participate will be centrally randomized to probiotic supplementation group or placebo group using computer-generated random numbers, that balanced allocation to groups A and B: in successive blocks each containing 20 patients each stratified by gender. The duration of the intervention will be 6 weeks.

For the participants, the Jordan University Hospital setting will be utilized for data collection. The patients will be recruited over 12 months and all patients will be asked to sign a written informed consent before enrollment. The patients will randomly be assigned to the placebo group (n=20), to receive 3 times a day placebo capsules contain polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste; and probiotics group (n=20), to receive 3 times a day probiotic supplement. The administration of supplements will be under the supervision of the treating physician. The blood sample will be collected at baseline and at the end of 6 weeks of follow up.

The demographic data of each subject will be collected such as; gender, age, body mass index (BMI), tumor location, malignant tumors stage, tumor differentiation, educational level, occupation, family history, smoking, dietary and physical activity. At baseline and end of the follow-up, IBD Quality of Life Questionnaire will be collected and blood sample tests will be withdrawn and the following biochemical variables will be measured: immunoglobulin G, immunoglobulin M, immunoglobulin A, interleukin-6 (IL-6), C-reactive protein (CRP), interleukin-1(IL-1), interleukin-10(IL-10), interleukin-12 (IL-12), Tumor necrosis factor-alpha (TNF-α) and complete blood count (CBC).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and female patients,
  • Age between 35 -65 years,
  • Diagnosed with UC established by colonoscopy and histology, and suffering from mild to moderate UC as defined by Modified Mayo Disease Activity Index (MMDAI) (score 3-9).

Exclusion criteria

  • Patients with age <35 years, >65 years,
  • Pregnancy, planned pregnancy, breastfeeding women,
  • Evidence of severe disease (MMDAI >10),
  • Concurrent enteric infection,
  • Use of antibiotics,
  • Change in the dose of oral 5-aminosalicylic acid (5-ASA) within the past 4weeks, and use of rectal 5-ASA or steroids within 7 days before entry into the study,
  • Received any investigational medicines within 3months,
  • If they have significant hepatic, renal, endocrine, respiratory, neurological, or cardiovascular diseases

Treatment and study plan

Probiotic Formula Capsule

Drug

The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.

Other names: Probiotics capsule, Probiotics supplement

Placebos

Drug

The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.

Other names: Placebo oral capsule

Primary outcomes

  1. The Level of Immunoglobulin (Ig) A

    Time frame: at the end of 6 weeks of follow-up

    The level of Immunoglobulin (Ig) A in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501

  2. The Level of Immunoglobulin (Ig) G

    Time frame: at the end of 6 weeks of follow up

    The level of Immunoglobulin (Ig) G in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501

  3. The Level of Immunoglobulin (Ig) M

    Time frame: at the end of 6 weeks of follow-up

    The level of Immunoglobulin (Ig) M in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501

  4. The Level of Interleukin (IL)-6

    Time frame: at the end of 6 weeks of follow-up

    The Level of Interleukin (IL)-6 in pg/ml measured aat the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA)

  5. The Level of Interleukin (IL)-1

    Time frame: at the end of 6 weeks of follow-up

    The Level of Interleukin (IL)-1 in pg/ml measured at the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA)

  6. The Level of Interleukin (IL)-10

    Time frame: at the endo f 6 weeks of follow-up

    The Level of Interleukin (IL)-10 in pg/ml was measured at the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA)

  7. The Level of Tumor Necrosis Factor (TNF)-α

    Time frame: at the endo of 6weeks of follow-up

    The Level of TNF-α in pg/ml measured at the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA)

  8. The Level of C-reactive Protein (CRP)

    Time frame: at the end of 6 weeks of follow-up

    The Level of CRP in mg/ml measured at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501

Secondary outcomes

  1. Quality of Life of Patients

    Time frame: at the end of 6 weeks of follow-up

    The average score of the general quality of life (QoL) subscales was assessed by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ). The SIBDQ contains 10 questions for 4 functional scales (Bowel, Systemic, emotional, and social). For each question, there a regraded responses on a 7-point Likert scale ranging from one (representing the ''worst'' aspect) to seven (representing the ''best'' aspect). Total SIBDQ scores range from 10 to 70.Higher scores reflect better well-being.

Other outcomes

  1. The Level of White Blood Cell Count (WBC)

    Time frame: at the end of 6 weeks of follow-up

    The level of WBC as cells*10^9/l measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

  2. The Level of Red Blood Cell Count (RBC)

    Time frame: at the end of 6 weeks of follow-up

    The level of RBC as cells*10^12/l measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

  3. The Mean Corpuscular Volume (MCV)

    Time frame: at the end of 6 weeks of follow-up

    The MCV in fl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

  4. The Mean Corpuscular Hemoglobin (MCH)

    Time frame: at the end of 6 weeks of follow-up

    The MCH in pg measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

  5. The Mean Corpuscular Hemoglobin Concentration (MCHC)

    Time frame: at the end of 6 weeks of follow-up

    The MCH in g/dl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

  6. The Platelet Count

    Time frame: at the end of 6 weeks of follow-up

    The Platelet count as cells 10^9/ll measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

  7. The of Hemoglobin

    Time frame: at the end of 6 weeks of follow-up

    The Hemoglobin in g/dl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

  8. The Mean Platelet Volume (MPV)

    Time frame: at the end of 6 weeks of follow-up

    The MPV in fl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

  9. The Level of Lymphocytes

    Time frame: at the end of 6 weeks of follow-up

    The number of lymphocytes cells as cells*10^9/L measuredat the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

  10. The Level of Monocytes

    Time frame: at the end of 6 weeks of follow-up

    The number of Monocytes cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

  11. The Level of Eosinophils

    Time frame: at the end of 6 weeks of follow-up

    The number of eosinophils cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

  12. The Level of Basophils

    Time frame: at the end of 6 weeks of follow-up

    The number of basophils cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

  13. The Level of Neutrophils

    Time frame: at the end of 6 weeks of follow-up

    The number of neutrophils cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2020
Registry last updated
Sep 19, 2024

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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