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Fecal Transplantation in Patients Colonic Diverticulitis

NCT06254625 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-05

No results posted yet for this study

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

Interventions

OTHER

Fecal Microbiome

Fecal microbiome transplantation from a healthy donor.

OTHER

Placebo

Place capsules

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Thomas Bjørsum-meyer, M.D., PhD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06254625 on ClinicalTrials.gov