RecruitingPhase 2NCT06687382

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.

Enrollment

81 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Diverticulitis Diverticulitis of Sigmoid

Summary

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 proposed as a mechanism involved in the transition from diverticulosis to diverticulitis, inflammation and some of the symptoms of the disease. In this way, fecal microbiota transplantation (FMT) could have an important role in the prevention of new episodes, as it can modify the composition of the intestinal microbiota in a less invasive and more physiological way. Until now the efficacy of FMT in patients with recurrent diverticulitis has not been assessed; however, its benefits and safety have been demonstrated in studies for inflammatory bowel disease (IBD), a pathology with similarities to diverticulitis in its symptoms and underlying inflammation. The objective of the present clinical trial is to assess the efficacy of MBK-01 (heterologous lyophilized intestinal microbiota oral capsules) in reducing the frequency of episodes in recurrent diverticulitis, its safety and tolerability and to determine the optimal dosing regimen.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

Patients of both sexes aged 18-70 (both included).
Three or more episodes compatible with a diagnosis of acute diverticulitis of the left or sigmoid colon in the 3 years prior to signing the informed consent. The diagnosis of each episode of diverticulitis must have been made by demonstrating inflammation in the colon compatible with diverticulitis in an imaging test (computed tomography or ultrasound) and presenting at least one of the following analytical or clinical alterations :abdominal pain, vomiting, intestinal obstruction, body temperature over 38ºC, constipation (less than one bowel movement every 3 days), elevated acute-phase reactants (leukocytes higher than 11,000 cells/µL and/or C-reactive protein (CRP) higher than 5mg/dL and/or procalcitonin higher than 0.2), rectal bleeding.
Not having had any symptomatic episode of acute diverticulitis in the 30 days prior to signing the informed consent.
In the case of women and men of reproductive age, for safety, those who agree to follow the required contraceptive measure from the signing of the informed consent until the penultimate visit of the follow-up period.
Patients who have signed the informed consent, either autonomously or through a legal representative.

Exclusion Criteria15

Patients for who the information on episodes of acute diverticulitis required for inclusion in the study cannot be fully verified.
Patients with acute diverticulitis in the ascending colon, transverse colon or other locations other than the descending or sigmoid colon.
Previous colonic resection of any segment of the colon.
Medical history of colorectal cancer.
Having taken a mechanical colonic preparation in the 3 months prior to signing the informed consent.
History of abdominal surgery.
Allergy or intolerance to any component of the investigational medicinal product or ancillary medicinal products (amoxicillin, clavulanic acid, fosfomycin or metronidazole) used in the trial.
Prior administration of fecal microbiota transplantation (FMT).
Systemic antibiotic treatment in the 30 days prior to signing the informed consent.
Taking a marketed probiotic/prebiotic/symbiotic in the 30 days prior to signing the informed consent.
Treatment with rifaximin or mesalazine in the 30 days prior to signing the informed consent.
Presence of hereditary or acquired immunodeficiency.
Chronic infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
Pregnancy or lactation.
Any other condition that, in the opinion of the investigator, could prevent or hinder compliance with the study.

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Interventions

BIOLOGICALMBK-01

Initial dose of 4 capsules of MBK-01 (heterologous lyophilized intestinal microbiota coming from healthy donors) orally the first day, followed by a single daily capsule during 16 days. Participants will receive a total dose of 20 capsules of MBK-01.

BIOLOGICALMBK-01

Initial dose of 4 capsules of MBK-01 (heterologous lyophilized intestinal microbiota coming from healthy donors) orally the first day, followed by a single daily capsule for 16 days and a maintenance dose 3 months after the ending of the initial dose. The maintenance dose is administered the same as the initial dose: 4 capsules of MBK-01 orally the first day, followed by a single daily capsule for 16 days. Participants will receive a total dose of 40 capsules of MBK-01.