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New treatment option for Diverticulitis
Official title Clinical Trial With MBK-01, Intestinal Microbiota Capsules, for the Treatment of Patients With Recurrent Diverticulitis
ClinicalTrials.gov ID: NCT06687382
What this study is testing
What is MBK-01?
MBK-01 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diverticulitis.
Also referred to as Fecal Microbiota Transplantation, Intestinal Microbiota Transplantation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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...
- Patients who have signed the informed consent, either autonomously or through a legal representative.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
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 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.