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Study on MBK-01 and Drug Combination for Treating Patients with Recurrent Diverticulitis

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of recurring diverticulitis, a condition where small, bulging pouches in the digestive tract become inflamed or infected repeatedly. The trial will use an investigational treatment called MBK-01, which consists of lyophilized capsules of fecal microbiota. These capsules are designed to help restore the natural balance of bacteria in the intestines. The study will also involve the use of other medications, including metronidazole, fosfomycin, and amoxicillin, which are commonly used antibiotics.

The purpose of the study is to evaluate how effective and safe the MBK-01 treatment is in reducing the frequency of acute diverticulitis episodes. Participants will be randomly assigned to receive either the MBK-01 treatment or a control treatment. The study will monitor the number of new episodes of acute diverticulitis, any side effects, and changes in health indicators throughout the trial. The trial will also help determine the best dosage of MBK-01 for treating this condition.

Participants will take the treatment orally, and the study will last for a period of time during which they will be regularly monitored by healthcare professionals. The trial aims to provide valuable information on how well MBK-01 works in managing recurring diverticulitis and its potential benefits for patients suffering from this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the clinical trial, you will be provided with detailed information about the study, including its purpose, procedures, and potential risks and benefits. You will be required to sign an informed consent form, confirming your understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility for the trial. This may include a review of your medical history and a physical examination. You will be asked about your previous episodes of diverticulitis and any symptoms you have experienced.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive the investigational medicinal product MBK-01, which consists of oral capsules containing intestinal microbiota. The dosage and frequency will be determined based on the specific regimen assigned to you. You may also receive other medications such as metronidazole, fosfomycin, and amoxicillin as part of the treatment plan. All medications will be taken orally.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored. You will have regular follow-up visits to assess the effectiveness and safety of the treatment. These visits may include physical examinations, laboratory tests, and questionnaires to evaluate your gastrointestinal health and overall quality of life.

  5. Step 5

    Completion of the trial

    At the end of the trial, a final assessment will be conducted to evaluate the outcomes of the treatment. You will be informed about the results and any further steps that may be necessary for your health care.

Who can join the trial?

12 criteria

  • Patients must be between the ages of 18 and 70.
  • Patients must have had three or more episodes of acute diverticulitis in the left or sigmoid colon in the past 3 years. Each episode must have been confirmed by an imaging test like a CT scan or ultrasound, showing inflammation in the colon.
  • During each episode, patients must have experienced at least one of the following symptoms:
    • Abdominal pain
    • Vomiting
    • Intestinal obstruction (a blockage in the intestines)
    • Body temperature higher than 38°C
    • Constipation (fewer than one bowel movement every 3 days)
    • Elevated acute phase reactants (high levels of certain substances in the blood indicating inflammation, such as leukocytes > 11,000 cells/µL, CRP > 5 mg/dL, or procalcitonin > 0.2)
    • Rectal bleeding
    • Patients must not have had any symptomatic episode of acute diverticulitis in the 30 days before signing the informed consent.
    • Women and men of reproductive age must agree to use contraceptive measures from the time of signing the informed consent until the second-to-last follow-up visit.
    • Patients must have signed the informed consent form, either by themselves or through a legal representative.

Who cannot join the trial?

5 criteria

  • Patients with a history of **recurring diverticulitis** cannot participate. Diverticulitis is a condition where small, bulging pouches in the digestive tract become inflamed or infected.
  • Individuals who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
  • Participants who are not part of the specified clinical trial groups are not eligible.
  • Both **male** and **female** participants are eligible, but those who do not meet other criteria will be excluded.
  • Individuals considered part of a **vulnerable population** are excluded. This term refers to groups who may be at a higher risk of harm or exploitation.
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Investigated drugs

MBK-01 is an investigational medicinal product being tested in this clinical trial. It comes in the form of oral capsules and is designed to help people with recurrent diverticulitis, a condition where small bulges or pockets in the digestive tract become inflamed or infected. The goal of MBK-01 is to reduce the number of times these painful episodes occur. It works by using a special blend of intestinal microbiota, which are beneficial bacteria that live in the gut. These bacteria can help maintain a healthy balance in the digestive system, potentially reducing inflammation and preventing future episodes of diverticulitis. The trial is also looking at how safe and tolerable MBK-01 is for patients, as well as finding the best way to use it for treatment.

What is already known about the treatment

MBK-01 – MBK-01 is administered in the form of oral capsules and is currently being studied in a Phase IIa clinical trial. It is an investigational treatment aimed at reducing the frequency of acute episodes in patients with recurrent diverticulitis. The medication works by utilizing Full Spectrum & Purified Intestinal Microbiota to potentially restore a healthy balance of gut bacteria, which may help in managing the condition. MBK-01 falls under the pharmacological classification of microbiota-based therapies.

Investigated diseases

Recurring Diverticulitis – Recurring diverticulitis is a condition characterized by repeated inflammation or infection of small pouches, called diverticula, that can form in the walls of the digestive tract, particularly the colon. These pouches develop when weak spots in the intestinal wall give way under pressure, causing small bulges. When these diverticula become inflamed or infected, it leads to diverticulitis, which can cause symptoms such as abdominal pain, fever, and changes in bowel habits. The inflammation can lead to complications like abscesses, perforations, or blockages in the colon. Over time, repeated episodes of diverticulitis can cause scarring and narrowing of the colon. The condition often requires careful management to prevent further episodes and maintain digestive health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506224-87-00Protocol codeDIREBIOTEstimated enrolment81 patientsSponsorMikrobiomik Healthcare Company S.L.

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