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Lactic Acid Bacteria in Functional Diarrheal Disorders

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Trial details

Who runs it
Szeged University
Trial code
NCT07916688
Record updated
4 November 2026
Original description
The goal of this clinical trial is to learn whether a probiotic supplement can improve symptoms and quality of life in adults with diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea (FD). These conditions can cause frequent loose stools, abdominal discomfort, and a lower quality of life.Read full original descriptionShow less

Efficacy of Lactic Acid Bacteria in Managing Diarrhea-Associated Functional Gastrointestinal Disorders: A Randomized Controlled Trial

The goal of this clinical trial is to learn whether a probiotic supplement can improve symptoms and quality of life in adults with diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea (FD). These conditions can cause frequent loose stools, abdominal discomfort, and a lower quality of life.

The main questions this study aims to answer are:

* Does the probiotic improve quality of life compared with a placebo (a look-alike capsule that contains no active bacteria)? * Does the probiotic help participants have more normal stool consistency and fewer bowel movements? * Is the probiotic safe and well tolerated in people with IBS-D or FD?

Researchers will compare the probiotic supplement with a placebo to see whether the probiotic improves symptoms and quality of life.

Participants will:

* Take either the probiotic or placebo capsule once daily for 3 months. * Switch to the other study treatment for an additional 3 months. * Complete quality-of-life questionnaires at the start of the study, after 3 months, and after 6 months. * Record the number of bowel movements each day throughout the study. * Record stool consistency each day using the Bristol Stool Form Scale. * Record daily pain during bowel movements using a Visual Analog Scale (VAS). * Report any medications they take and any health problems that occur during the study.

The study will follow each participant for 6 months. Researchers hope the results will help determine whether this probiotic is a useful treatment option for people living with IBS-D or functional diarrhea.

Inclusion: Adults aged 18 years or older; Have diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea (FD) diagnosed using Rome V criteria; Have had symptoms for at least 6 months; Have no warning signs that suggest another digestive disease; Have been taking the same treatment for IBS-D, FD, and other medical conditions for at least 1 month before joining the study; Are willing and able to provide written informed consent and follow study procedures.

Exclusion: Had abdominal surgery in the past, except appendix removal (appendectomy); Plan to start a new medication or change the dose of an existing medication during the study (except antispasmodic medications); Have another type of irritable bowel syndrome or another functional digestive disorder; Have a known digestive disease that may explain their symptoms; Took antibiotics or probiotic products within the past 4 weeks; Are unable or unwilling to complete study questionnaires and daily symptom records.

ClinicalTrials.gov NCT07916688