Clinical Trial With MBK-01, Intestinal Microbiota Capsules, for the Treatment of Patients With Recurrent Diverticulitis

Launched by MIKROBIOMIK HEALTHCARE COMPANY S.L. · Nov 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MBK-01, which is a type of intestinal microbiota capsule, for patients who frequently experience diverticulitis, a condition that causes inflammation in the colon. The goal is to see if these capsules can help reduce the number of diverticulitis episodes and improve patients' overall health and quality of life. Traditional treatments, like antibiotics, often do not work for everyone, and researchers believe that changing the bacteria in the gut might offer a better solution.

To be eligible for this trial, participants must be between 18 and 70 years old and have had at least three episodes of acute diverticulitis in the past three years. They should not have experienced any symptoms of diverticulitis in the 30 days before joining the study. Participants will take the capsules and will be monitored for safety and effectiveness over time. This trial aims to find out if this new treatment can offer a safer and more effective way to prevent recurring diverticulitis episodes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.