NCT06852274

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Dr. Amjad Khan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diverticular Diseases
• Gastro-Intestinal Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Clostridium butyricum CBM588® (Butirrisan®)	Probiotic
DRUG	Rifaximin 400 mg Oral Tablet	Antibiotic

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-04-30
• Completion: 2024-10-31
• First posted: 2025-02-28
• Last updated: 2025-05-18

Locations

1 site across 1 country: Italy