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

Dr. Amjad Khan

Status: Completed

Conditions: Diverticular Diseases; Gastro-Intestinal Disorder

Treatments: Drug: Rifaximin 400 mg Oral Tablet; Dietary Supplement: Clostridium butyricum CBM588® (Butirrisan®)

Study type: Interventional

Funder types: Other

Identifiers

NCT06852274

CESU/104/07.05.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Probiotic + Fiber Supplementation Group (Probiotic Group)

Other group

Description:

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.

Treatment:

Dietary Supplement: Clostridium butyricum CBM588® (Butirrisan®)

Rifaximin + Fiber Supplementation Group (Control Group)

Other group

Description:

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.

Treatment:

Drug: Rifaximin 400 mg Oral Tablet