CompletedNot Applicable

Safety and Efficacy of a Probiotic Supplement in IBS-D

Slovenia46 participantsStarted 2023-06-06

Plain-language summary

This study aims to assess the safety and efficacy of a single probiotic strain on symptom severity in adults with diarrhea-predominant Irritable Bowel Syndrome (IBS-D).

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 * Males and females aged ≥18 to ≤ 65 years. * Participants diagnosed with diarrhoea-predominant irritable bowel syndrome (IBS-D) as per ROME IV criteria: i) Recurrent abdominal pain on average at least one day/week in the last three months, associated with two or more of the following criteria: * Related to defecation * Associated with a change in stool frequency (increase/decrease in frequency). * Associated with a change in the form (appearance) of stool. ii) History of abnormal bowel movements predominantly diarrhoea (\>25% of bowel movements categorised as stool form type 6 or 7 (diarrhoea) and \<25% as stool form type 1 or 2 (constipation) on BSFS). * Participants with an IBS-SSS score ≥ 175. * Participants who test negative for COVID-19 by Rapid Antigen Test Device. * Participants who did not change their diet within three months before the screening day and are willing to sustain that diet during the study. * Participants who can comply and perform the procedures as per the protocol (consumption of study products, biological sample collection procedures, and study visit schedule). * Participants who are literate enough to understand the purpose of the study and their rights. * Participants who are able to give written informed consent and are willing to participate in the study. Exclusion criteria * Participants who score ≥ 40 in either the 'state' or 'trait' section of the STAI-AD questionnaire (both sections to be assessed). * Participa…

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 in total irritable bowel syndrome symptom severity score (IBS-SSS)

Timeframe: Day 0, Day 28, Day 58 and Day 84

Trial details

NCT IDNCT05754177

SponsorThe Archer-Daniels-Midland Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-30

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

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.