Diverticulitis Trials in Disease

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

This clinical trial is investigating a new treatment approach for people who experience recurring episodes of diverticulitis. The study focuses on an investigational therapy called MBK-01, which consists of oral capsules containing intestinal microbiota. These beneficial bacteria are designed to help restore a healthy balance in the gut, potentially reducing inflammation and preventing future episodes of the condition.

Main inclusion criteria:

• Patients must be between 18 and 70 years of age
• Must have experienced three or more episodes of acute diverticulitis in the left or sigmoid colon within the past 3 years
• Each episode must have been confirmed by imaging tests such as CT scan or ultrasound showing colon inflammation
• During episodes, patients must have experienced at least one symptom including abdominal pain, vomiting, intestinal obstruction, fever above 38°C, constipation, elevated inflammatory markers in blood tests, or rectal bleeding
• Must not have had any symptomatic episode in the 30 days before joining the trial
• Women and men of reproductive age must agree to use contraceptive measures throughout the study

Main exclusion criteria:

• Individuals outside the specified age range cannot participate
• Participants who do not meet other specific study criteria
• Individuals considered part of vulnerable populations who may be at higher risk of harm or exploitation

Focus and goal of the trial:

The primary purpose of this study is to evaluate how effective and safe MBK-01 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. Throughout the study, healthcare professionals will monitor the number of new episodes, any side effects, and changes in health indicators. The trial also aims to determine the optimal dosage of MBK-01 for treating this condition.

The study involves several phases. After joining and providing informed consent, participants undergo an initial assessment to confirm eligibility, including a review of medical history and physical examination. During the treatment phase, participants receive MBK-01 oral capsules along with other medications that may include metronidazole, fosfomycin, and amoxicillin, which are antibiotics commonly used in managing this condition. Regular follow-up visits throughout the trial include physical examinations, laboratory tests, and questionnaires to evaluate gastrointestinal health and quality of life.

Investigational drug:

MBK-01 is the main investigational treatment being tested in this trial. It is a microbiota-based therapy that contains lyophilized capsules of fecal microbiota, which includes beneficial bacteria that naturally live in the gut. The therapy aims to restore the natural balance of intestinal bacteria, potentially helping to maintain digestive health and prevent inflammatory episodes. This Phase IIa trial is examining both the safety and effectiveness of this novel approach to treating recurring diverticulitis.