NCT06676514: PROREDI

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

Completed NA Last updated 7 May 2025

What this trial tests

NA trial testing Probiotic Clostridium butyricum CBM588® in IBS-D (Diarrhea-predominant) in 405 participants. Completed in 10 March 2025.

Timeline

10 November 2024

Primary endpoint
24 February 2025

10 March 2025

Quick facts

Lead sponsor	Liaquat University of Medical & Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	405
Start date	10 November 2024
Primary completion	24 February 2025
Estimated completion	10 March 2025
Sites	1 location across Italy

Drugs / interventions tested

• Probiotic Clostridium butyricum CBM588®
• Standard of care IBS-D treatment

Conditions studied

• IBS-D (Diarrhea-predominant) — all drugs for IBS-D (Diarrhea-predominant) →

Sponsor

Liaquat University of Medical & Health Sciences

Who can join

18 and older, any sex, with IBS-D (Diarrhea-predominant). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Irritable Bowel Syndrome with Diarrhea (IBS-D): Effects of <i>Clostridium butyricum</i> CBM588 Probiotic on Gastrointestinal Symptoms, Quality of Life, and Gut Microbiota in a Prospective Real-Life Interventional Study.
   Di Pierro F, Ficuccilli F, Tessieri L, Menasci F, et al · · 2025 · cited 2× · PMID 40431311 · DOI 10.3390/microorganisms13051139