Clostridium Butyricum CBM588® vs. Rifaximin for Symptomatic Uncomplicated Diverticular Disease (SUDD): A Real-World Retrospective Study

Management of Symptomatic Uncomplicated Diverticular Disease (SUDD) of the Colon With Clostridium Butyricum CBM588® Versus Rifaximin: Results From a Real-World Retrospective Italian Study

This retrospective, real-world, single-center clinical study aimed to evaluate the effectiveness of probiotic Clostridium butyricum CBM588® (Butirrisan®) versus Rifaximin in the management of Symptomatic Uncomplicated Diverticular Disease (SUDD). Patients with diverticulosis and a history of mild-to-moderate diverticulitis were included, and their clinical outcomes were assessed using existing patient records.

The study compared two treatment groups:

Experimental Group: Clostridium butyricum CBM588® (Butirrisan®) + fiber supplementation.

Control Group: Rifaximin + fiber supplementation.

The primary endpoint was the reduction in SUDD symptoms, evaluated using patient-reported outcomes. Secondary outcomes included assessment of safety, risk of surgery, and changes in abdominal pain frequency and severity.

Study Overview

• Status: Completed
• Conditions: Diverticular Diseases; Gastro-Intestinal Disorder
• Intervention / Treatment: Dietary supplement: Clostridium butyricum CBM588® (Butirrisan®); Drug: Rifaximin 400 mg Oral Tablet

Detailed Description

Diverticulosis is a common condition affecting up to 60% of individuals over 60 years old, with 10-25% developing Symptomatic Uncomplicated Diverticular Disease (SUDD). This condition is characterized by chronic low-grade inflammation, altered gut microbiota, and persistent abdominal symptoms such as bloating, pain, and irregular bowel habits.

Traditional treatment often involves cyclic rifaximin therapy. However, recent studies have highlighted the potential of microbiome-modulating therapies, including probiotics such as Clostridium butyricum CBM588®, to improve gut health, reduce inflammation, and manage SUDD symptoms.

This retrospective, real-world study reviewed clinical records of 70 patients who received treatment for SUDD at a single center. The data were extracted from routine clinical practice records, without any prospective patient recruitment. Patients were categorized into two groups:

The probiotic group received Clostridium butyricum CBM588® (Butirrisan®) with fiber supplementation.

The control group received Rifaximin 400 mg twice daily for 7-10 days per month, alongside fiber supplementation.

Outcomes were measured based on symptom relief over a 12-month period, including the frequency and severity of abdominal pain, the risk of surgery, and patient-reported outcomes. The study provided real-world evidence on the potential benefits of Clostridium butyricum CBM588® in supporting a microbiome-targeted approach for managing SUDD, potentially reducing reliance on antibiotics and improving patient quality of life.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Varese, Italy
    • Medicine & Technological Innovation Dept. University of Insubria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged ≥18 years
• Diagnosed diverticulosis (confirmed by colonoscopy or CT scan)
• History of mild-to-moderate diverticulitis
• Symptomatic Uncomplicated Diverticular Disease (SUDD) requiring management

Exclusion Criteria:

• Prior abdominal surgery
• History of inflammatory bowel disease (IBD) or colorectal cancer
• Use of antibiotics or probiotics within 4 weeks prior to study entry
• Severe chronic comorbidities (e.g., advanced liver or kidney disease)
• Pregnancy or breastfeeding
• Patients with acute diverticulitis within the past 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Probiotic + Fiber Supplementation Group (Probiotic Group); Participants in this group received Clostridium butyricum CBM588® (Butirrisan®) probiotic at a dose of 3 tablets/day for 1 month, followed by 3 tablets/day for 2 weeks per month for 12 months, in addition to fiber supplementation. These treatments were administered as part of routine clinical care, and data were collected retrospectively from patient records.	Dietary supplement: Clostridium butyricum CBM588® (Butirrisan®); Probiotic; Other Names: Butirrisan®, PharmExtracta S.p.A.
Other: Rifaximin + Fiber Supplementation Group (Control Group); Participants in this group received Rifaximin 400 mg twice daily for 7-10 days per month along with fiber supplementation. These treatments were administered as part of routine clinical care, and data were collected retrospectively from patient records.	Drug: Rifaximin 400 mg Oral Tablet; Antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Symptoms of Diverticular Disease	Assessment Tool: Patient-reported outcome questionnaires derived from clinical records. Description: Evaluation of symptom relief, including changes in abdominal pain, bloating, and bowel habit irregularities, based on patient records.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Safety and Tolerability of Clostridium butyricum CBM588®	Review of adverse events and overall tolerability of probiotic therapy as documented in clinical records.	12 months
Incidence of Surgical Intervention in Patients with Diverticular Disease	Percentage of patients requiring surgical intervention due to complications of diverticular disease, as confirmed by medical records. Measurement Tool: Review of surgical records and patient medical charts. Unit of Measure: % of patients requiring surgery.	12 months
Changes in Abdominal Pain Frequency, Duration, and Severity	Symptom tracking via a validated pain scale extracted from patient records. Frequency Scale: 1: <1x/week, 2: 1-2x/week, 3: 3-6x/week, 4: Daily. Duration Scale: 1: <30 min, 2: 0.5-1h, 3: 1-6h, 4: >6h. Severity Scale: 0: No pain, 1: Mild, 2: Moderate, 3: Severe, 4: Very severe.	12 months

Collaborators and Investigators

• Sponsor: Dr. Amjad Khan
• Collaborators: San Giovanni Addolorata Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: February 22, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Gastroenteritis; Diverticular Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Diverticulum; Anti-Bacterial Agents; Anti-Infective Agents; Gastrointestinal Agents; Rifaximin
• Other Study ID Numbers: CESU/104/07.05.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No