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Completed

NCT Number: NCT06676514

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

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.

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Key information

Conditions

IBS-D (Diarrhea-predominant)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Quisisana Clinic

Itala, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Clostridium butyricum CBM588®

Dietary Supplement

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

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.

Primary outcomes

  1. Changes in Irritable Bowel Syndrome Symptom Severity Scale

    Time frame: 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)

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

    Time frame: 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.

  3. Changes in patients daily frequency of evacuation and diarrhea episodes

    Time frame: 8-weeks

    Probiotic effect on patients frequency of evacuation and diarrhea episodes

  4. Number of patients reporting side effects

    Time frame: 8-weeks

    Safety evaluation of probiotic

Secondary outcomes

  1. Changes in Quality of Life Assessment Questionnaire Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • University of Urbino "Carlo Bo"

Registry information

Official study title

Evaluation of the Efficacy of Clostridium Butyricum CBM588® on Symptoms and Quality of Life in Patients With Diarrhea-dominant Irritable Bowel Syndrome (PROREDI: (PRObiotic REmedy for DIarrhea)

Acronym: PROREDI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 6, 2024
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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