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NCT Number: NCT06852274

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medicine & Technological Innovation Dept. University of Insubria

Varese, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Clostridium butyricum CBM588® (Butirrisan®)

Dietary Supplement

Probiotic

Other names: Butirrisan®, PharmExtracta S.p.A.

Rifaximin 400 mg Oral Tablet

Drug

Antibiotic

Primary outcomes

  1. Change in Symptoms of Diverticular Disease

    Time frame: 12 months

    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.

Secondary outcomes

  1. Assessment of Safety and Tolerability of Clostridium butyricum CBM588®

    Time frame: 12 months

    Review of adverse events and overall tolerability of probiotic therapy as documented in clinical records.

  2. Incidence of Surgical Intervention in Patients with Diverticular Disease

    Time frame: 12 months

    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.

  3. Changes in Abdominal Pain Frequency, Duration, and Severity

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Dr. Amjad Khan

Other

Collaborators

  • San Giovanni Addolorata Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2025
Registry last updated
May 18, 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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