Actively Recruiting
Clinical Trial With MBK-01, Intestinal Microbiota Capsules, for the Treatment of Patients With Recurrent Diverticulitis
Led by Mikrobiomik Healthcare Company S.L. · Updated on 2025-06-05
81
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 18-70 (both included).
- Three or more episodes of acute diverticulitis of the left or sigmoid colon in the past 3 years confirmed by imaging and clinical or laboratory signs.
- No symptomatic episode of acute diverticulitis in the 30 days before signing informed consent.
- Agreement to use required contraceptive measures during the study if of reproductive age.
- Signed informed consent provided by patient or legal representative.
You will not qualify if you...
- Inability to verify required information on acute diverticulitis episodes.
- Acute diverticulitis in colon locations other than descending or sigmoid colon.
- Previous colonic resection.
- History of colorectal cancer.
- Mechanical colonic preparation within 3 months before signing informed consent.
- History of abdominal surgery.
- Allergy or intolerance to any study or related antibiotics.
- Prior fecal microbiota transplantation.
- Systemic antibiotic use within 30 days prior to informed consent.
- Use of probiotics, prebiotics, symbiotics, rifaximin, or mesalazine within 30 days prior to informed consent.
- Hereditary or acquired immunodeficiency.
- Chronic infectious diseases including hepatitis B, hepatitis C, or HIV.
- Pregnancy or lactation.
- Any condition that could prevent study compliance as judged by the investigator.
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Trial Site Locations
Total: 1 location
1
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
Research Team
O
Olaia Aurtenetxe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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