CompletedNot Applicable

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

Italy70 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Symptoms of Diverticular Disease

Timeframe: 12 months

Trial details

NCT IDNCT06852274

SponsorDr. Amjad Khan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-30