MBK-01 intestinal microbiota capsules to prevent recurrent sigmoid diverticulitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IIa randomized, controlled, open-label trial assigns participants 1:1:1 to MBK-01 without maintenance, MBK-01 with a maintenance dose at three months, or a no-intervention control. Participants in the MBK-01 arms receive a three-day antibiotic pretreatment (amoxicillin, fosfomycin and metronidazole), a two-day washout, then an initial dosing regimen of four capsules on day one followed by one capsule daily for 16 days (20 capsules total); the maintenance arm repeats that 17-day regimen at month three. Eligible adults are 18–70 with imaging-confirmed recurrent left or sigmoid diverticulitis (three or more episodes in the prior three years) and no symptomatic episode within 30 days. The study will compare recurrence rates and monitor safety and tolerability between arms.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario Ramón y Cajal
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Juan Ocaña Jiménez — Hospital Universitario Ramon y Cajal
• Study coordinator: Olaia Aurtenetxe
• Email: ensayosclinicos@mikrobiomik.net
• Phone: +34 944 540 166

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.