Clostridium Butyricum CBM588® vs. Rifaximin for Symptomatic Uncomplicated Diverticular Disease (SUDD)

This randomized, real-life, single-center clinical trial aims to compare the efficacy and safety 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 will be randomized into two treatment groups:

Experimental Group: Clostridium butyricum CBM588® (Butirrisan®) + fiber supplementation Control Group: Rifaximin + fiber supplementation The primary endpoint is the reduction in SUDD symptoms, assessed over a 12-month treatment period using patient-reported questionnaires. Secondary outcomes include safety evaluation, risk of surgery, and changes in abdominal pain frequency and severity.

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 includes cyclic rifaximin therapy, but recent research suggests that butyrate-producing probiotics, such as Clostridium butyricum CBM588®, may offer an alternative approach. CBM588® is known for its ability to modulate the gut microbiota, enhance intestinal barrier function, and reduce inflammation, making it a promising therapeutic option for SUDD management.

This randomized, open-label, interventional trial will enroll 70 participants to evaluate the efficacy of Clostridium butyricum CBM588® (Butirrisan®) in the management of Symptomatic Uncomplicated Diverticular Disease (SUDD). Participants will be randomized into two groups: the probiotic group, receiving Butirrisan® at 3 tablets/day for 1 month, followed by 3 tablets/day for 2 weeks/month for 12 months, alongside fiber supplementation; and the control group, receiving Rifaximin 400 mg twice daily for 7-10 days per month for 12 months, also with fiber supplementation. The primary outcome will assess symptom relief over 12 months using patient-reported outcome questionnaires. Secondary outcomes include safety evaluation, risk of surgery, and changes in abdominal pain severity and frequency. This study aims to provide evidence 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
* Ability to provide informed consent

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