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NCT06852274

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

Completed NA Last updated 18 May 2025
What this trial tests

NA trial testing Clostridium butyricum CBM588® (Butirrisan®) in Diverticular Diseases in 70 participants. Completed in 31 October 2024.

Timeline
1 March 2023
Primary endpoint
30 April 2024
31 October 2024

Quick facts

Lead sponsorDr. Amjad Khan
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment70
Start date1 March 2023
Primary completion30 April 2024
Estimated completion31 October 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Dr. Amjad Khan

Who can join

18 and older, any sex, with Diverticular Diseases or Gastro-Intestinal Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Management of symptomatic uncomplicated diverticular disease (SUDD) of the colon with Clostridium butyricum CBM588 versus rifaximin: a retrospective cross-sectional study.
    Urgesi R, Pagnini C, De Angelis F, Khan A, et al · · 2025 · PMID 41108431 · DOI 10.1007/s00384-025-05005-6

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Other recruiting trials for Diverticular Diseases

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing