Clinical Trial With MBK-01, Intestinal Microbiota Capsules, for the Treatment of Patients With Recurrent Diverticulitis

NCT06687382 | Recruiting Phase 2

• 2 other identifiers: DIREBIOT2023-506224-87-00
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with diverticulitis experience a prolonged course of the disease and report a variety of physical, psychological and social symptoms, which highly impacts in their quality of life. Although antibiotic therapy has been the preferred treatment option for acute diverticulitis, it does not control the disease in 40 percent of the patients with complicated diverticulitis and 13 to 23 percent of the patients with non-complicated diverticulitis, which results in chronic and recurrent episodes of diverticulitis. As the episodes repeat, the outpatient conservative treatment has worse success rates and the incidence of complicated diverticulitis with abscess increases up to five times. Therefore, it is of great importance to establish new treatments in order to avoid the recurrences of the disease. As of today, there is not enough evidence of the efficacy of current treatment options to prevent recurrences in patients with diverticulitis, but recent approaches suggest the modification of intestinal microbiota as a preventive strategy. Microbial imbalance (dysbiosis) has been proposed as a mechanism involved in the transition from diverticulosis to diverticulitis, inflammation and some of the symptoms of the disease. In this way, fecal microbiota transplantation (FMT) could have an important role in the prevention of new episodes, as it can modify the composition of the intestinal microbiota in a less invasive and more physiological way. Until now the efficacy of FMT in patients with recurrent diverticulitis has not been assessed; however, its benefits and safety have been demonstrated in studies for inflammatory bowel disease (IBD), a pathology with similarities to diverticulitis in its symptoms and underlying inflammation. The objective of the present clinical trial is to assess the efficacy of MBK-01 (heterologous lyophilized intestinal microbiota oral capsules) in reducing the frequency of episodes in recurrent diverticulitis, its safety and tolerability and to determine the optimal dosing regimen.

Conditions

Diverticulitis; Diverticulitis of Sigmoid

Keywords

Recurrent Diverticulitis; Diverticular Disease; Acute Diverticulitis; Diverticulosis; Fecal Microbiota Transplantation; Fecal Microbiota Transfer; Intestinal Microbiota

Outcome Measures

Primary Outcomes (16)

• Number of new episodes of acute diverticulitis during the trial

  Diagnosis of the new episode by diagnostic imaging (computed tomography scan or ultrasound) and the presence of at least one of the following symptoms: abdominal pain, vomits, intestinal obstruction, body temperature over 38ºC, constipation, elevated acute-phase reactants leukocytes higher than 11,000 cells/µL and/or C-reactive protein higherthan 5mg/dl and/or procalcitonin higher than 0.2), hematochezia reported by the patient.

  Up to 1 year after the start of the treatment

• Time to first episode of acute diverticulitis

  Time in weeks from the signing of the informed consent to the first episode of acute diverticulitis.

  Up to 1 year after the start of the treatment

• Time to successive episodes of acute diverticulitis (other than the first episode)

  Time in weeks from the signing of the informed consent to successive episodes of acute diverticulitis (different from the first episode).

  Up to 1 year after the start of the treatment

• Time between episodes of acute diverticulitis

  Time in weeks between episodes of acute diverticulitis during the trial.

  Up to 1 year after the start of the treatment

• Number of hospitalizations due to acute diverticulitis in the trial

  Number of hospitalizations because of acute diverticulitis during the trial.

  Up to 1 year after the start of the treatment

• Number courses of systemic antibiotic treatment used in the trial for the episodes of acute diverticulitis

  Number of systemic antibiotic treatment cycles used during the trial for the episodes of acute diverticulitis.

  Up to 1 year after the start of the treatment

• Need for surgery for acute diverticulitis during the trial

  Number of patients that abandon the study because of the need for surgery for acute diverticulitis.

  Up to 1 year after the start of the treatment

• Occurrence of Adverse Events (AES)

  Frequency of AES.

  Up to 1 year after the start of the treatment

• Occurrence of Serious Adverse Events (SAES)

  Frequency of SAES.

  Up to 1 year after the start of the treatment

• Occurrence of AES that result in discontinuation of study treatment

  Frequency of AES that result in discontinuation of study treatment.

  Up to 1 year after the start of the treatment

• Occurrence of AES of special interest (AESI)

  Frequency of AESI.

  Up to 1 year after the start of the treatment

• Occurrence of diverticulitis-related AES

  Frequency of diverticulitis-related AES.

  Up to 1 year after the start of the treatment

• Changes in vital signs

  Frequency of patients with abnormal changes in vital signs (systolic blood pressure, diastolic blood pressure, body temperature and heart rate).

  Up to 1 year after the start of the treatment

• Changes in laboratory values

  Frequency of patients with abnormal changes in laboratory values (biochemical, hematological and coagulation, lipidic, thyroid, hepatitis B and C virus, human immunodeficiency virus (HIV) and diverticulitis related parameters (C-reactive protein and procalcitonin)).

  Up to 1 year after the start of the treatment

• Number of new episodes of acute diverticulitis in the trial between the two MBK-01 regimens

  Diagnosis of the new episode by diagnostic imaging (computed tomography scan or ultasound) and the presence of at least one of the following symptoms: abdominal pain, vomits, intestinal obstruction, body temperature over 38ºC, constipation, elevated acute-phase reactants leukocytes higher than 11,000 cells/µL and/or C-reactive protein higher than 5mg/dl and/or procalcitonin higher than 0.2), hematochezia reported by the patient.

  Up to 1 year after the start of the treatment

• Occurrence of treatment-related AES between the two MBK-01 regimens during the trial

  Frequency of AES related to the treatment with MBK-01.

  Up to 1 year after the start of the treatment

Secondary Outcomes (2)

• Effect of capsule-based fecal microbiota transplantation (FMT) patient-perceived on health outcome, measured by changes in the Gastrointestinal Quality of Life Index (GIQLI) questionnaire

  Day 0, 16 weeks (3 months for the MBK-01 group), 6 months and 1 year after the start of the treatment

• Effect of capsule-based FMT patient-perceived on health outcome, measured by changes in the SF-36 questionnaire

  Day 0, 16 weeks (3 months for the MBK-01 group), 6 months and 1 year after the start of the treatment.

Study Arms (3)

MBK-01 with no maintenance dose

EXPERIMENTAL

Participants will receive MBK-01 capsules of intestinal microbiota coming from healthy donors. They will receive an initial dose of 4 capsules the first day, followed by a single daily capsule during 16 days.

Biological: MBK-01

MBK-01 with maintenance dose

EXPERIMENTAL

Participants will receive MBK-01 capsules of intestinal microbiota coming from healthy donors. They will receive an initial dose of 4 capsules the first day, followed by a single daily capsule during 16 days. 3 months after the ending of the initial dose they will receive a maintenance dose, administered the same as the initial dose.

Biological: MBK-01

No intervention

NO INTERVENTION

Participants will not receive any intervention.

Interventions

MBK-01 BIOLOGICAL

Initial dose of 4 capsules of MBK-01 (heterologous lyophilized intestinal microbiota coming from healthy donors) orally the first day, followed by a single daily capsule during 16 days. Participants will receive a total dose of 20 capsules of MBK-01.

Also known as: Fecal Microbiota Transplantation, Intestinal Microbiota Transplantation

MBK-01 with no maintenance dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes aged 18-70 (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 (computed tomography or ultrasound) and presenting at least one of the following analytical or clinical alterations :abdominal pain, vomiting, intestinal obstruction, body temperature over 38ºC, constipation (less than one bowel movement every 3 days), elevated acute-phase reactants (leukocytes higher than 11,000 cells/µL and/or C-reactive protein (CRP) higher than 5mg/dL and/or procalcitonin higher than 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 measure from the signing of the informed consent until the penultimate visit of the follow-up period.
• Patients who have signed the informed consent, either autonomously or through a legal representative.

You may not qualify if:

• 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 fecal microbiota transplantation (FMT).
• Systemic antibiotic treatment in the 30 days prior to signing the informed consent.
• 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 hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
• Pregnancy or lactation.
• Any other condition that, in the opinion of the investigator, could prevent or hinder compliance with the study.

Sponsors & Collaborators

• Mikrobiomik Healthcare Company S.L.: lead

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

RECRUITING

MeSH Terms

Conditions

Diverticulitis; Diverticular Diseases; Diverticulum

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Juan Ocaña Jiménez

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olaia Aurtenetxe

CONTACT

+34 944 540 166; ensayosclinicos@mikrobiomik.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 13, 2024
• Study Start: April 3, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

ES (1)