Fecal Microbiota Transplantation in Postoperative Crohn's Disease
Not applicable · Testing Fecal Microbiota Transplantation · 2 sites · Tampere University Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fecal Microbiota Transplantation to see if it can prevent disease or complications. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 120
- Any sex
Some of the main requirements, copied from the record:
- Over 18 years
- Able to provide written consent
- Stricturing and/or fistulizing Crohn's disease needing ileocecal or ileal resection
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2021-05-18.
- Main results expected around 2023-12 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in Finland.
Main thing being measured
- Change in endoscopic Rutgeerts score between first and second colonoscopy (1 year)
In the researchers’ words
This pilot study aims to detect possible trends or signals suggesting efficacy of FMT on prevention of delay of POR, to determine the safety of FMT in post operative CD, and asses if a full randomised controlled trial is feasible in this setting. With microbiota analysis we aim to assess if changes in gut microbiota are related to disease course of CD after operation.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Tampere University Hospital |
| Collaborators | Turku University Hospital; Joint Authority for Päijät-Häme Social and Health Care; Kuopio University Hospital; Helsinki University Central Hospital; Tampere University |
| Enrollment | 20 (estimated) |
| Start date | 2021-05-18 |
| Primary completion (est.) | 2023-12 |
| First posted | 2020-11-19 |
| Last updated | 2022-10-27 |
| Official title | Fecal Microbiota Transplantation in Postoperative Crohn's Disease |
| ClinicalTrials.gov ID | NCT04637438 |
Interventions
- Fecal Microbiota Transplantation (Other)
FMT via colonoscopy - Placebo (Other)
Water infusion via colonoscopy
Full eligibility criteria (from the record)
Inclusion Criteria: * Over 18 years * Able to provide written consent * Stricturing and/or fistulizing Crohn's disease needing ileocecal or ileal resection Exclusion Criteria: * Pregnancy * Active infection, abscess or fistula at the time of the first colonoscopy * Life expectancy <1 year * Unable to provide written consent * Use on antibiotics or probiotics at the time of first colonoscopy
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Tampere University Hospital | Tampere | Finland | Recruiting |
| Tampere University Hospital | Tampere | Finland | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.