UnknownPhase 1

Fecal Transplantation in Patients Colonic Diverticulitis

Denmark40 participantsStarted 2024-04-01

Plain-language 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 \[insert effects\]

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- 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 Exclusion Criteria: * 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 pol…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 3 months

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

Timeframe: 3 months

Trial details

NCT IDNCT06254625

SponsorOdense University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-31

Contact for this trial

Camilla Thorndal Nielsen, Medical student

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

View on ClinicalTrials.gov More Diverticulitis, Colonic trials