A Phase 4 interventional study of Probiotic formulation and Placebo in IBS - Irritable Bowel Syndrome, sponsored by Lallemand Health Solutions. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Lallemand Health Solutions · Phase 4, Interventional, and Supportive care
The purpose of the study is to monitor safety and to evaluate the efficacy of a probiotic formulation on abdominal pain, abnormal defecation, comorbid mood disorders (anxiety and depression) as well as general quality of life in adults with IBS-D.
To monitor safety and to evaluate the efficacy of a probiotic formulation on severity of gastrointestinal symptoms (abdominal pain, abnormal defecation), anxiety, depression and quality of life in adult participants with IBS-D.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 162 is above the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Lallemand Health Solutions is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in this group will be randomized to receive probiotic formulation for the following 8 weeks.
Drug: Probiotic formulation
Participants in this group will be randomized to receive placebo for the following 8 weeks.
Drug: Placebo
Participants will be asked to take 2 doses daily
Participants will be asked to take 2 doses daily
Change in Abdominal Pain
Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)
Time frame: 8 weeks
Change in Defecation consistency
Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)
Time frame: 8 weeks
Change Abdominal pain intensity
Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)
Time frame: up to 10 weeks
Abnormal defecation consistency
Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)
Time frame: up to 10 weeks
Stool frequency
Measured as the average number of stools per week
Time frame: up to 10 weeks
Abdominal discomfort
Using questionnaire in participants diary
Time frame: up to 10 weeks
Perceived Stress
Using the Perceived Stress Scale (PSS) grading from 0 (low stress) to 40 (high perceived stress)
Time frame: 8 weeks
Change in Irritable Bowel Syndrome Symptom Severity Scores
Using the The irritable bowel severity scoring system (IBS-SSS)
Time frame: 8 weeks
Plan to share: No — After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lallemand Health Solutions