Phase 2Recruiting
Clinical Trial With MBK-01, Intestinal Microbiota Capsules, for the Treatment of Patients With Recurrent Diverticulitis
A Phase IIa Randomized, Controlled, Open-label Clinical Trial to Assess the Efficacy, Safety, and Tolerability of the Investigational Medicinal Product MBK-01, FSPIM (Full Spectrum & Purified Intestinal Microbiota) Oral Capsules, as Well as to Determine the Optimal Dosage in the Treatment of Patients With Recurrent Diverticulitis (DIREBIOT)
- Sponsor
- Mikrobiomik Healthcare Company S.L. (Industry)
- Enrolment
- 81 planned
- Conditions
- Diverticulitis; Diverticulitis of Sigmoid
- Interventions
- MBK-01; MBK-01
- Ages
- adults, older adults
- Registry
- NCT06687382, CTIS2023-506224-87-00
Full record on ClinicalTrials.gov
From the registry
Patients with diverticulitis experience a prolonged course of the disease and report a variety of physical, psychological and social symptoms, which highly impacts in their quality of life. Although antibiotic therapy has been the preferred treatment option for acute diverticulitis, it does not control the disease in 40 percent of the patients with complicated diverticulitis and 13 to 23 percent of the patients with non-complicated diverticulitis, which results in chronic and recurrent episodes of diverticulitis. As the episodes repeat, the outpatient conservative treatment has worse success rates and the incidence of complicated diverticulitis with abscess increases up to five times. Therefore, it is of great importance to establish new treatments in order to avoid the recurrences of the disease. As of today, there is not enough evidence of the efficacy of current treatment options to prevent recurrences in patients with diverticulitis, but recent approaches suggest the modification of intestinal microbiota as a preventive strategy. Microbial imbalance (dysbiosis) has been…
Primary outcomes
- Number of new episodes of acute diverticulitis during the trial
- Time to first episode of acute diverticulitis
- Time to successive episodes of acute diverticulitis (other than the first episode)
- Time between episodes of acute diverticulitis
History
Primary completion expected
Last registry update
Started
Registered