Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Launched by LALLEMAND HEALTH SOLUTIONS · Aug 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special probiotic formulation on adults with Irritable Bowel Syndrome with Diarrhea (IBS-D). The main goals are to see if the probiotic can help reduce abdominal pain, improve bowel movements, and enhance overall quality of life, including mental well-being. The study is currently looking for participants aged 18 to 75 who have been diagnosed with IBS-D and have had symptoms for at least six months. To be eligible, participants should have had a normal colonoscopy and not have any serious gastrointestinal diseases or mood disorders.

If you decide to join the trial, you will take the probiotic for a certain period and report your symptoms throughout the study. It’s important to note that if you regularly use anti-diarrhea medications or laxatives, you might need to stop using them for a while before joining. The trial aims to gather valuable information about how this probiotic can help people living with IBS-D, so your participation could contribute to better treatment options in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Experiencing symptoms of IBS-D
• • Having a diagnosis of IBS-D based on Rome IV criteria
• • Participants with symptom onset at least 6 months before diagnosis
• • Having a normal colonoscopy result in their medical file
• Exclusion Criteria:
• • A history of inflammatory or immune-mediated gastrointestinal diseases
• • Diagnosed with a co-existing organic gastrointestinal disease which can affect the study
• • Currently undergoing a treatment for other severe conditions such as coronary disease, neurological disorder, kidney or liver disease,
• • Currently diagnosed with an eating disorder,
• • Having undergone any abdominal surgery including cholecystectomy, with the exception of hernia repair or appendectomy
• • Currently diagnosed with any mood- or anxiety-related disorder, major psychiatric illness, or participants with a history of suicidal ideation, or current suicidal ideation,
• • Regular use of anti-diarrhea medications and laxatives however occasional use is permitted (≤ than once a month); if current use is \> once per month a one month wash out is needed,
• • Unwilling to avoid the use of antidiarrheal or laxative medication on an "as-needed basis" during the full length of the study,
• • Pregnant, breast-feeding or planning on becoming pregnant.