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

NCT06676514 | Completed DMC

• 1 other identifier: 104_7maggio2023_Clostrydium
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS-D (Diarrhea-predominant)

Outcome Measures

Primary Outcomes (4)

• Changes in Irritable Bowel Syndrome Symptom Severity Scale

  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)

  8-weeks

• Changes in Fecal Consistency as assessed through the Bristol Stool Form Scale

  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.

  8-weeks

• Changes in patients daily frequency of evacuation and diarrhea episodes

  Probiotic effect on patients frequency of evacuation and diarrhea episodes

  8-weeks

• Number of patients reporting side effects

  Safety evaluation of probiotic

  8-weeks

Secondary Outcomes (1)

• Changes in Quality of Life Assessment Questionnaire Score

  8-weeks

Study Arms (2)

Probiotic group

EXPERIMENTAL

This group received probiotic treatment for IBS-D as three tablets daily for 8-weeks

Dietary Supplement: Probiotic Clostridium butyricum CBM588®

Control group

ACTIVE COMPARATOR

This group received standard of care treatment for IBS-D.

Other: Standard of care IBS-D treatment

Interventions

Probiotic Clostridium butyricum CBM588® DIETARY_SUPPLEMENT

This group received probiotic Clostridium butyricum CBM588® treatment for IBS-D as three tablets daily for 8 weeks.

Probiotic group

Standard of care IBS-D treatment OTHER

Patients in this group received standard of care IBS-D treatment of Trimebutine maleate maleate and followed a lactose-free, no-slag diet.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• University of Urbino "Carlo Bo": collaborator

Study Sites (1)

Quisisana Clinic

Itala, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 6, 2024
• Study Start: November 10, 2024
• Primary Completion: February 24, 2025
• Study Completion: March 10, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

IT (1)