Clinical trial NCT06852274: Clostridium Butyricum CBM588® vs. Rifaximin for Symptomatic Uncomplicated Diverticular Disease (SUDD): A Real-World Retrospective Study
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diverticular Diseases
Gastro-Intestinal Disorder
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: San Giovanni Addolorata Hospital
First posted: 2025-02-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Symptoms of Diverticular Disease
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of Safety and Tolerability of Clostridium butyricum CBM588®
timeFrame: 12 months
measure: Incidence of Surgical Intervention in Patients with Diverticular Disease
timeFrame: 12 months
measure: Changes in Abdominal Pain Frequency, Duration, and Severity
timeFrame: 12 months
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Medicine & Technological Innovation Dept. University of Insubria
Study officials:
References: