Actively Recruiting
A Phase IIa Randomized, Controlled, Open-label Trial to Assess MBK-01 Oral Capsules for Safety and Effectiveness in Recurrent Diverticulitis
Led by Mikrobiomik Healthcare Company S.L. · Updated on 2025-06-05
81
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with recurrent diverticulitis, a condition marked by repeated episodes of inflammation in the colon that significantly affects quality of life through physical, psychological, and social symptoms. Traditional antibiotic treatments often fail to control the disease in many patients, leading to chronic and recurrent episodes, and an increased risk of complications. The study aims to evaluate a new treatment approach using MBK-01, an oral capsule containing lyophilized intestinal microbiota, to reduce the frequency of diverticulitis episodes and improve patient outcomes. Participants will be randomly assigned to one of three groups: one receiving MBK-01 without a maintenance dose, another receiving MBK-01 with a maintenance dose three months after the initial treatment, and a control group receiving no intervention. Those in the MBK-01 groups will first undergo a three-day antibiotic pre-treatment followed by a two-day washout period before starting MBK-01 capsules. The treatment involves an initial dose of 4 capsules on the first day and a daily capsule for the next 16 days, with the maintenance group receiving an identical regimen three months later. The control group will receive usual care without preventive medication. Throughout one year of follow-up, participants will attend six clinic visits to monitor health and treatment effects. These visits include physical exams, lab tests, stool samples, and questionnaires assessing gastrointestinal quality of life and general health. Researchers will track episodes of diverticulitis, hospitalizations, surgeries, antibiotic use, and any adverse events. The study will assess the safety, tolerability, and optimal dosing of MBK-01 while observing its impact on patient-perceived health outcomes and the frequency of diverticulitis episodes.
CONDITIONS
Brief Title
Clinical Trial With MBK-01, Intestinal Microbiota Capsules, for the Treatment of Patients With Recurrent Diverticulitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of both sexes aged 18 to 70 years
- Three or more episodes of acute diverticulitis in the left or sigmoid colon within the past 3 years
- Diagnosis of diverticulitis confirmed by imaging and clinical or laboratory signs
- No symptomatic diverticulitis episode in the 30 days prior to enrollment
- Agreement to use contraceptive measures if of reproductive age
- Signed informed consent
You will not qualify if you...
- Inability to verify required diverticulitis episode information
- Diverticulitis located outside the descending or sigmoid colon
- Previous colonic resection
- History of colorectal cancer
- Mechanical colonic preparation within 3 months before enrollment
- History of abdominal surgery
- Allergy or intolerance to study medications
- Prior fecal microbiota transplantation
- Systemic antibiotic treatment within 30 days before enrollment
- Use of probiotic, prebiotic, or symbiotic products within 30 days before enrollment
- Treatment with rifaximin or mesalazine within 30 days before enrollment
- Hereditary or acquired immunodeficiency
- Chronic infectious diseases such as hepatitis B, hepatitis C, or HIV
- Pregnancy or lactation
- Any condition that may interfere with study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 3 days
Participants in the experimental groups will take antibiotics for 3 days before starting the MBK-01 treatment.
No scheduled visits during this phase
Duration - 2 days
Participants in the experimental groups will have a 2-day washout period after antibiotics before starting MBK-01 treatment.
No scheduled visits during this period
Duration - 17 days for initial dose; maintenance dose lasts 17 days starting 3 months after initial dose for one group
Participants in the experimental groups receive MBK-01 capsules: an initial dose of 4 capsules on the first day, followed by a daily capsule for 16 days. One experimental group will also receive a maintenance dose 3 months later, administered the same way.
No scheduled visits during treatment
Duration - 1 year
Participants attend follow-up visits to monitor health status, treatment effects, adherence, and any episodes of diverticulitis for up to 1 year after starting treatment.
6 visits: at 1 week, 4 weeks, 16 weeks (3 months for maintenance group), 6 months, and 1 year after treatment start
Trial Site Locations
Total: 1 location
1
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
Research Team
O
Olaia Aurtenetxe
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here