ALLOGENEIC FAECAL MICROBIOTA, POOLED for Recurrent diverticulitis | Acute diverticulitis

Inclusion criteria

• {"criterion_text":"- Patients of both sexes aged 18-70 years (both included).\n- 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.\n- Not having had any symptomatic episode of acute diverticulitis in the 30 days prior to signing the informed consent.\n- 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).\n- Patients who have signed the informed consent, either autonomously or through a legal representative."}

Exclusion criteria

• {"criterion_text":"- Patients for whom the information on episodes of acute diverticulitis required for inclusion in the study cannot be fully verified.\n- Taking a marketed probiotic/prebiotic/symbiotic in the 30 days prior to signing the informed consent.\n- Treatment with rifaximin or mesalazine in the 30 days prior to signing the informed consent.\n- Presence of hereditary or acquired immunodeficiency.\n- Chronic infectious diseases such as HBV, HCV or HIV.\n- Pregnancy or lactation.\n- Any other condition that, in the opinion of the investigator, could prevent or hinder compliance with the study.\n- Patients with acute diverticulitis in the ascending colon, transverse colon or other locations other than the descending or sigmoid colon.\n- Previous colonic resection of any segment of the colon.\n- Medical history of colorectal cancer.\n- Having taken a mechanical colonic preparation in the 3 months prior to signing the informed consent.\n- History of abdominal surgery.\n- 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.\n- Prior administration of FMT.\n- Systemic antibiotic treatment in the 30 days prior to signing the informed consent."}

Primary endpoints

• {"endpoint_text":"- Number of new episodes of acute diverticulitis during the trial.\n- Occurrence of adverse events (AEs), serious AEs (SAEs), AEs resulting in discontinuation of study treatment, AEs of special interest (AESI), diverticulitis-related AEs, and changes in vital signs and laboratory values during the clinical trial.\n- Number of new episodes of acute diverticulitis in the trial between the two MBK-01 regimens.\n- Occurrence of treatment-related adverse events between the two MBK-01 regimens during the trial.","definition_or_measurement_approach":"- Number of new episodes of acute diverticulitis during the trial: Episodes are diagnosed by demonstrating inflammation in the colon compatible with diverticulitis on an imaging test (CT or ultrasound) and presenting at least one of the listed clinical or analytical alterations (abdominal pain, vomiting, intestinal obstruction, body temperature > 38ºC, constipation as defined, elevated acute phase reactants, rectal bleeding).\n- Occurrence of AEs/SAEs/AESI/etc.: standard AE reporting during the clinical trial including collection of AEs, SAEs, AEs leading to treatment discontinuation, AESI, diverticulitis-related AEs, and monitoring of vital signs and laboratory values (as stated in the endpoint description).\n- Number of new episodes between MBK-01 regimens: comparison/count of new acute diverticulitis episodes occurring under each MBK-01 treatment regimen during the trial.\n- Occurrence of treatment-related adverse events between MBK-01 regimens: comparison of treatment-related AEs between the two MBK-01 regimens during the trial."}

Secondary endpoints

• {"endpoint_text":"- Time to first episode of acute diverticulitis.\n- Time to successive episodes of acute diverticulitis (other than the first episode.\n- Time to successive episodes of acute diverticulitis (other than the first episode.\n- Number of hospitalizations due to acute diverticulitis in the trial.\n- Number of courses of systemic antibiotic treatments used in the trial for episodes of acute diverticulitis.\n- Need for surgery for acute diverticulitis during the trial.\n- Changes in the Gastrointestinal Quality of Life Index (GIQLI) questionnaire.\n- Changes in the SF-36 questionnaire.","definition_or_measurement_approach":"- Time to first/successive episodes: endpoint described as time-based endpoints; no detailed start/stop time definition provided in the source.\n- Number of hospitalizations due to acute diverticulitis: count of hospital admissions for diverticulitis during the trial; detailed criteria not provided in the source.\n- Number of courses of systemic antibiotic treatments: count of systemic antibiotic treatment courses used for diverticulitis episodes during the trial; further specification not provided.\n- Need for surgery: occurrence of surgical intervention for diverticulitis during the trial; further specification not provided.\n- Changes in GIQLI and SF-36: measurement via the Gastrointestinal Quality of Life Index and SF-36 questionnaires; specific timing of assessments not specified in the source."}

Spain

Earliest CTIS Part Ii Submission Date

27-10-2023

Latest Decision Or Authorization Date

14-10-2024

Processing Time Days

353

Number Of Sites

1

Number Of Participants

81

Primary sponsor

Full Name

Mikrobiomik Healthcare Company S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Contract research organisations

Name

Sermes CRO

Responsibilities

On site monitoring, Statistical analysis, Medical writing, Regulatory expertise, Project management, Safety reporting

Third parties

• {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"On site monitoring, Statistical analysis, Medical writing, Regulatory expertise, Project management, Safety reporting","organisation_type":"Pharmaceutical company"}