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NOT YET RECRUITING
NCT06254625
PHASE1

Fecal Transplantation in Patients Colonic Diverticulitis

Sponsor: Odense University Hospital

View on ClinicalTrials.gov

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 \[insert effects\]

Official title: Fecal Transplantation in Patients With Colonic Diverticulitis: a Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-04-01

Completion Date

2024-12-31

Last Updated

2024-04-05

Healthy Volunteers

Yes

Interventions

OTHER

Fecal Microbiome

Fecal microbiome transplantation from a healthy donor.

OTHER

Placebo

Place capsules

Locations (1)

Odense University Hospital

Odense, Funen, Denmark