Clostridium Butyricum CBM588® vs. Rifaximin for Symptomatic Uncomplicated Diverticular Disease (S… (NCT06852274) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.