A Phase IIa randomized, controlled, open-label clinical trial to assess the efficacy, safety, and tolerability of the investigational medicinal product MBK-01, FSPIM (Full Spectrum & Purified Intestinal Microbiota) oral capsules, as well as to determine the optimal dosage in the treatment of patients with recurrent diverticulitis (DIREBIOT). - DIREBIOT

Mikrobiomik Healthcare Company S.L.0 个研究点目标入组 81 人开始时间: 2023年9月26日最近更新: 2024年7月22日

研究概览

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•Patients of both sexes aged 18-70 years (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 been made by demonstrating inflammation in the colon compatible with diverticulitis in an imaging test (CT or ultrasound) and presenting at least one of the following analytical or clinical alterations: - Abdominal pain. - Vomiting. - Intestinal obstruction. - Body temperature > 38ºC. - Constipation (number of bowel movements less than one bowel movement every 3 days). - Elevated acute phase reactants (leukocytes > 11,000 cells/µL and/or CRP > 5 mg/dL and/or procalcitonin > 0.2). - Rectal bleeding., 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 measures from the signing of the informed consent until the penultimate visit of the follow-up period (V5)., Patients who have signed the informed consent, either autonomously or through a legal representative.

•Patients for whom the information on episodes of acute diverticulitis required for inclusion in the study cannot be fully verified., 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 HBV, HCV or HIV., Pregnancy or lactation., Any other condition that, in the opinion of the investigator, could prevent or hinder compliance with the study., 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 FMT., Systemic antibiotic treatment in the 30 days prior to signing the informed consent.

发起方

Mikrobiomik Healthcare Company S.L.