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

Sponsored by Dr. Amjad Khan

About this trial

Last updated a year ago

Study ID

CESU/104/07.05.2024

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Ended 2 years ago

What is this trial 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.

What are the participation requirements?

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