BridgeMD
Clinical trial with MBK-01, intestinal microbiota capsules, for the treatment of patients with recurring diverticulitis
EU CTIS ID: 2023-506224-87-00
What this study is testing
1. To assess the efficacy of MBK-01 and its different treatment regimens versus the control group in reducing the frequency of acute diverticulitis episodes. 2. To assess the safety and tolerability of MBK-01 in its different treatment regimens in patients with diverticulitis. 3. Determination of the optimal dosing regimen for MBK-01
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of both sexes aged 18-70 years (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 (CT or ultrasound) and presenting at least one of the following analytical or clinical alterations: - Abdominal pain. - Vomiting. - Intestinal obstruction. - Body temperature > 38ºC. - Constipation (number of bowel movements less than one bowel movement every 3 days). - Elevated acute phase reactants (leukocytes > 11,000 cells/µL and/or CRP > 5 mg/dL and/or procalcitonin > 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 measures from the signing of the informed consent until the penultimate visit of the follow-up period (V5).
- Patients who have signed the informed consent, either autonomously or through a legal representative.
You likely can't join if
- Patients for whom the information on episodes of acute diverticulitis required for inclusion in the study cannot be fully verified.
- 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 HBV, HCV or HIV.
- Pregnancy or lactation.
See the full eligibility criteria
- Patients of both sexes aged 18-70 years (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 (CT or ultrasound) and presenting at least one of the following analytical or clinical alterations: - Abdominal pain. - Vomiting. - Intestinal obstruction. - Body temperature > 38ºC. - Constipation (number of bowel movements less than one bowel movement every 3 days). - Elevated acute phase reactants (leukocytes > 11,000 cells/µL and/or CRP > 5 mg/dL and/or procalcitonin > 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 measures from the signing of the informed consent until the penultimate visit of the follow-up period (V5).
- Patients who have signed the informed consent, either autonomously or through a legal representative.
- Patients for whom the information on episodes of acute diverticulitis required for inclusion in the study cannot be fully verified.
- 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 HBV, HCV or HIV.
- Pregnancy or lactation.
- Any other condition that, in the opinion of the investigator, could prevent or hinder compliance with the study.
- 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 FMT.
- Systemic antibiotic treatment in the 30 days prior to signing the informed consent.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.