Fecal Transplantation in Patients Colonic Diverticulitis

NCT06254625 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 333-2023-AK
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the safety and effect of fecal microbiome transplantation (FMT) in patients with a former episode of acute colonic diverticulitis. The main question\[s\] it aims to answer are:

• Is FMT in patients with a former episode of acute colonic diverticulitis a safe procedure without severe adverse events
• What is the impact of FMT on patient-reported outcomes and re-admission rate Participants will be asked to:
• to ingest either 25-30 capsules with FMT or placebo capsules
• Fill-in GI-QLI questionnaire prior to treatment/placebo and 3 months post baseline
• Fill-in eating habit questionnaire
• deliver blood-and stool samples prior to treatment/placebo and 3 months post baseline
• In both the treatment and placebo group 5 patients will be offered sigmoideoscopy for mucosal biopsies if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\]

Conditions

Diverticulitis, Colonic; Colon Inflamed

Keywords

Fecal microbiome; Fecal microbiome transplantation; Colonic diverticulitis

Outcome Measures

Primary Outcomes (2)

• Proportion of patients treated with antibiotics within 3 months following FMT comparing FMT and placebo.

  3 months

• Patient safety monitored by a) number of re-admissions, and b) number of adverse events within 3 months of FMT.

  3 months

Secondary Outcomes (2)

• Change from baseline to 3 months in the GI-QLI questionnaire

  3 months

• Change from baseline to 3 months in: fecal bacteria composition and metabolism

  3 months

Study Arms (2)

Fecal microbiome transplantation

EXPERIMENTAL

25-30 capsules are ingested with apple juice or coca cola light, and the patient is observed for 30-60 minutes before they are allowed to go home. The capsules are to be ingested within 4 hours of thawing. Each transplant, comprising 25-30 capsules, contain 50 g of feces originating from one donor.

Other: Fecal Microbiome

Placebo

PLACEBO COMPARATOR

The placebo group receives 25-30 placebo capsules.

Other: Placebo

Interventions

Fecal Microbiome OTHER

Fecal microbiome transplantation from a healthy donor.

Fecal microbiome transplantation

Placebo OTHER

Place capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- CT-confirmed Acute Uncomplicated Diverticulitis: Eligible patients should have a confirmed diagnosis of acute uncomplicated diverticulitis based on in-hospital CT scans.
• The condition must be defined as an infection limited to the colon, not extending to the peritoneum, and the patients should not require antibiotics treatment for their diverticulitis.
• This definition ensures that the study focuses on cases of uncomplicated diverticulitis.
• \- Admission to Odense University Hospital (Odense/Svendborg): Participants must be admitted to Odense University Hospital in Odense or Svendborg for the diagnosis and initial management of acute uncomplicated diverticulitis

You may not qualify if:

• Inability to provide Informed Consent: Patient who are unable to comprehend the study information and provide informed consent due to cognitive impairment, language barriers or any other reason will be excluded.
• Cognitive or Physical Impairment: Patients with disabilities that hinder their ability to comply with the study procedures, either cognitively or physically, will be excluded.
• Complicated Diverticulitis: patients with complicated diverticulitis, as defined by the presence of abscesses, fistulas, perforations, or other severe complications on the CT scan, will not be eligible for participation.
• CT Findings Requiring Biopsy or Polyp Removal: Individuals with CT findings indicating the need for colonoscopy to perform biopsy (e.g., suspected cancer) or for polyp removal will not be eligible for the study.
• Presence of Other Gastrointestinal Diseases: Patients with other gastrointestinal diseases, for such as IBD, will be excluded to maintain a homogeneous study population.
• Immunocompromised Patients: Individuals with known immunodeficiency disorders or undergoing immunosuppressive thearapy will be excluded due to potential safety concerns associated with FMT.
• History of FMT: Patients with a previous history of FMT will be excluded rom the study to avoid any potential confounding factors.
• Pregnant and Lactation: Pregnant or lactating individuals will not be included to ensure the safety of both the mother and the fetus/infant..
• Allergies to Active Substances in the Trial: Patients with known allergies to the active substances administered in the trial will not be eligible for participation.
• Participation in Other Clinical Trials: Individuals currently participating in other clinical trials involving investigational drugs or interventions will not be eligible to avoid potential interference with study outcomes

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Funen, 5000, Denmark

Location

Related Publications (1)

• Thorndal C, Kragsnaes MS, Nilsson AC, Holm DK, dePont Christensen R, Ellingsen T, Kjeldsen J, Bjorsum-Meyer T. Safety and efficacy of faecal microbiota transplantation in patients with acute uncomplicated diverticulitis: study protocol for a randomised placebo-controlled trial. Therap Adv Gastroenterol. 2025 Jan 2;18:17562848241309868. doi: 10.1177/17562848241309868. eCollection 2025.

  PMID: 39758967 DERIVED

MeSH Terms

Conditions

Diverticulitis, Colonic; Colitis

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Diverticulitis; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Diverticulosis, Colonic; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Thomas Bjørsum-meyer, M.D., PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Thorndal Nielsen, Medical student

CONTACT

+45 65415190; Camilla.Thorndal.Nielsen@rsyd.dk

Thomas Bjørsum-meyer, M.D., PhD

CONTACT

+4565415190; thomas.bjoersum-meyer@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: February 12, 2024
• Study Start: April 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

DK (1)