Study to Evaluate the Treatment Benefits of Probiotic Clostridium Butyricum CBM588® for IBS-D

Not Applicable

Completed

• Conditions: IBS-D (Diarrhea-predominant)

• Registration Number: NCT06676514
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief Summary

Irritable bowel syndrome (IBS) is a prevalent gastrointestinal disorder affecting 15-20% of people in industrialized countries, often presenting as abdominal discomfort, pain, and altered bowel habits, significantly impacting quality of life. Among IBS subtypes, IBS-D (diarrhea-predominant) is marked by frequent, loose bowel movements, identified using the Bristol Stool Form Scale (BSFS) and classified according to Rome IV criteria. Emerging research indicates that alterations in gut microbiota, particularly a decline in butyrate-producing bacteria like \*Clostridium butyricum\*, play a critical role in IBS-D. Butyrate is an essential short-chain fatty acid that provides energy to colonocytes and supports intestinal health, but its deficiency may contribute to intestinal inflammation, impaired sodium and water absorption, and diarrhea. \*Clostridium butyricum CBM588®\* is a unique butyrate-producing bacterium that withstands oxygen, making it viable for therapeutic use. Originating from Japan, CBM588® has shown promise in enhancing gut microbiota balance, improving symptoms in IBS-D, and supporting intestinal integrity. Although primarily studied in Asian populations, additional research in Caucasian patients is warranted to validate its broader applicability and potential benefits in IBS-D symptom management.

Detailed Description

The aim of this prospective, open-label, interventional study, based on clinical data collected from real-world clinical settings, is to assess the safety and efficacy of Clostridium butyricum CBM588® in patients with IBS-D. The study consists of two cohort groups:

A cohort, where patients will receive probiotic Butirrisan® (Clostridium butyricum CBM588®) as three tablets daily, taken in the morning either before or after breakfast, for a continuous period of eight weeks.

A control cohort, consisting of IBS-D patients who received the standard of care treatment (Trimebutin maleate followed by Lactose-free, no-slag diet).

The study evaluates changes in IBS symptom severity, fecal consistency, daily frequency of evacuation and diarrhea episodes, and quality of life at the end of the treatment. The primary outcome measures include changes in the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), fecal consistency assessed through the Bristol Stool Form Scale (BSFS), and the frequency of evacuation and diarrhea episodes. Additionally, safety will be evaluated by assessing the number of patients reporting adverse effects. The secondary outcome measure is an evaluation of quality of life, assessed using a qualitative questionnaire. Comparative analyses will be performed between the prospective Butirrisan®-treated group and the control group (Trimebutin maleate + Lactose-free, no-slag diet) to determine the relative effectiveness of probiotic therapy versus standard care.

Study Timeline

• Study First Submitted: 2024-11-02
• Study First Submitted QC: 2024-11-04
• Study First Posted: 2024-11-06
• Study Start: 2024-11-10
• Primary Completion: 2025-02-24
• Study Completion: 2025-03-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-04
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

• male and female, aged ≥18 years
• diagnosed with IBS-D according to the Rome IV criteria

Exclusion Criteria

• the use of antibiotic therapies
• use of laxative therapies
• the presence of organic gastrointestinal diseases
• resection of the digestive system
• the state of pregnancy or breastfeeding
• history of drug use and alcohol abuse
• the presence of an ascertained food allergy
• the presence of lactose intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Irritable Bowel Syndrome Symptom Severity Scale	8-weeks	The scale ranges from 0 to 500, with higher scores indicating worse symptom severity. Scores are categorized as follows: 0-75 (remission), 75-174 (mild), 175-299 (moderate), and 300-500 (severe)
Changes in Fecal Consistency as assessed through the Bristol Stool Form Scale	8-weeks	Fecal consistency will be assessed using the Bristol Stool Form Scale, which categorizes stool from Type 1 (hard lumps) to Type 7 (liquid). Changes toward Types 3-4 indicate improvement, while shifts to Types 1 or 7 suggest worsening.
Changes in patients daily frequency of evacuation and diarrhea episodes	8-weeks	Probiotic effect on patients frequency of evacuation and diarrhea episodes
Number of patients reporting side effects	8-weeks	Safety evaluation of probiotic

Secondary Outcome Measures

Name	Time	Method
Changes in Quality of Life Assessment Questionnaire Score	8-weeks	Quality of life will be assessed through a qualitative scale with scores range from 1 to 5, with responses as follows: 1 = Not at all, 2 = Slightly, 3 = Moderately, 4 = Quite a lot, and 5 = Absolutely yes. Higher scores indicate a significant IBS impact on quality of life.

Trial Locations

Locations (1)

Quisisana Clinic; 🇮🇹 Itala, Italy