Clinical trial with MBK-01, intestinal microbiota capsules, for the treatment of patients with recurring diverticulitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Mikrobiomik Healthcare Company S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

14 Oct 2024 → ongoing

Decision date (initial)

2024-01-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Mikrobiomik Healthcare Company S.L.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis, Dose response, Safety

1. To assess the efficacy of MBK-01 and its different treatment regimens versus the control group in reducing the frequency of acute diverticulitis episodes.
2. To assess the safety and tolerability of MBK-01 in its different treatment regimens in patients with diverticulitis.
3. Determination of the optimal dosing regimen for MBK-01

Secondary objectives 1

1. To assess the effect of capsule-based FMT on patient-perceived health outcomes

Conditions and MedDRA coding

Recurring diverticulitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients of both sexes aged 18-70 years (both included).
2. 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.
3. Not having had any symptomatic episode of acute diverticulitis in the 30 days prior to signing the informed consent.
4. 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).
5. Patients who have signed the informed consent, either autonomously or through a legal representative.

Exclusion criteria 15

1. Patients for whom the information on episodes of acute diverticulitis required for inclusion in the study cannot be fully verified.
2. Patients with acute diverticulitis in the ascending colon, transverse colon or other locations other than the descending or sigmoid colon.
3. Previous colonic resection of any segment of the colon.
4. Medical history of colorectal cancer.
5. Having taken a mechanical colonic preparation in the 3 months prior to signing the informed consent.
6. History of abdominal surgery.
7. 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.
8. Prior administration of FMT.
9. Systemic antibiotic treatment in the 30 days prior to signing the informed consent.
10. Taking a marketed probiotic/prebiotic/symbiotic in the 30 days prior to signing the informed consent.
11. Treatment with rifaximin or mesalazine in the 30 days prior to signing the informed consent.
12. Presence of hereditary or acquired immunodeficiency.
13. Chronic infectious diseases such as HBV, HCV or HIV.
14. Pregnancy or lactation.
15. Any other condition that, in the opinion of the investigator, could prevent or hinder compliance with the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Number of new episodes of acute diverticulitis during the trial.
2. 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.
3. Number of new episodes of acute diverticulitis in the trial between the two MBK-01 regimens.
4. Occurrence of treatment-related adverse events between the two MBK-01 regimens during the trial.

Secondary endpoints 8

1. Time to first episode of acute diverticulitis.
2. Time to successive episodes of acute diverticulitis (other than the first episode.
3. Time to successive episodes of acute diverticulitis (other than the first episode.
4. Number of hospitalizations due to acute diverticulitis in the trial.
5. Number of courses of systemic antibiotic treatments used in the trial for episodes of acute diverticulitis.
6. Need for surgery for acute diverticulitis during the trial.
7. Changes in the Gastrointestinal Quality of Life Index (GIQLI) questionnaire.
8. Changes in the SF-36 questionnaire.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Mikrobiomik Healthcare Company S.L.

Sponsor organisation

Mikrobiomik Healthcare Company S.L.

Address

Astondo Bidea 612

City

Derio

Postcode

48160

Country

Spain

Scientific contact point

Organisation

Mikrobiomik Healthcare Company S.L.

Contact name

Clinical trial information desk

Public contact point

Organisation

Mikrobiomik Healthcare Company S.L.

Contact name

Clinical trial information desk

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications