CompletedNot Applicable

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

France80 participantsStarted 2022-01-04

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 include…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of the severity of IBS-C symptoms

Timeframe: At weeks 0, 4, 8 and 12

Trial details

NCT IDNCT04997057

SponsorCEN Biotech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-09

View on ClinicalTrials.gov More Irritable Bowel Syndrome With Constipation trials