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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-10-31

Brief Summary

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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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Detailed Description

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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

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Diverticular Diseases Gastro-Intestinal Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Probiotic + Fiber Supplementation Group (Probiotic Group)

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.

Group Type OTHER

Clostridium butyricum CBM588® (Butirrisan®)

Intervention Type DIETARY_SUPPLEMENT

Probiotic

Rifaximin + Fiber Supplementation Group (Control Group)

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.

Group Type OTHER

Rifaximin 400 mg Oral Tablet

Intervention Type DRUG

Antibiotic

Interventions

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Clostridium butyricum CBM588® (Butirrisan®)

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Rifaximin 400 mg Oral Tablet

Antibiotic

Intervention Type DRUG

Other Intervention Names

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Butirrisan®, PharmExtracta S.p.A.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No