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

NCT06852274 | Completed DMC

• 1 other identifier: CESU/104/07.05.2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diverticular Diseases; Gastro-Intestinal Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of Safety and Tolerability of Clostridium butyricum CBM588®

  12 months

• Incidence of Surgical Intervention in Patients with Diverticular Disease

  12 months

• Changes in Abdominal Pain Frequency, Duration, and Severity

  12 months

Study Arms (2)

Probiotic + Fiber Supplementation Group (Probiotic Group)

OTHER

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®)

Rifaximin + Fiber Supplementation Group (Control Group)

OTHER

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

Interventions

Clostridium butyricum CBM588® (Butirrisan®) DIETARY_SUPPLEMENT

Probiotic

Also known as: Butirrisan®, PharmExtracta S.p.A.

Probiotic + Fiber Supplementation Group (Probiotic Group)

Rifaximin 400 mg Oral Tablet DRUG

Antibiotic

Rifaximin + Fiber Supplementation Group (Control Group)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Amjad Khan: lead
• San Giovanni Addolorata Hospital: collaborator

Study Sites (1)

Medicine & Technological Innovation Dept. University of Insubria

Varese, Italy

Location

Related Publications (1)

• Urgesi R, Pagnini C, De Angelis F, Khan A, Pallotta L, Fanello G, Antypas P, Di Paolo MC, Villotti G, Bertuccioli A, Sisti D, Di Pierro F, Zerbinati N, Graziani MG. Management of symptomatic uncomplicated diverticular disease (SUDD) of the colon with Clostridium butyricum CBM588 versus rifaximin: a retrospective cross-sectional study. Int J Colorectal Dis. 2025 Oct 18;40(1):216. doi: 10.1007/s00384-025-05005-6.

  PMID: 41108431 DERIVED

MeSH Terms

Conditions

Diverticular Diseases; Digestive System Diseases

Interventions

Rifaximin; Tablets

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This retrospective, real-world clinical study reviewed patient records to evaluate the effectiveness of Rifaximin with fiber supplementation for managing Symptomatic Uncomplicated Diverticular Disease (SUDD). Patients who received this antibiotic and fiber combination in a routine clinical setting were included. The study assessed symptom reduction, prevention of surgery, and changes in patient-reported outcomes. No prospective randomization was performed, and all data were derived from existing clinical records, reflecting routine clinical practice.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental medicine

Model Details: This retrospective, real-world clinical study reviewed patient records to evaluate the effectiveness of Clostridium butyricum CBM588® (Butirrisan®) with fiber supplementation for managing Symptomatic Uncomplicated Diverticular Disease (SUDD). Patients who received this probiotic and fiber combination in a routine clinical setting were included. The study assessed symptom reduction, prevention of surgery, and changes in patient-reported outcomes. No prospective randomization was performed, and all data were derived from existing clinical records, reflecting routine clinical practice.

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 28, 2025
• Study Start: March 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: October 31, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)