Fecal Microbiota Transplantation in Postoperative Crohn's Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04637438
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Tampere University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Finland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Arms & Interventions

Arms

Active Comparator: Fecal Microbiota Transplantation

Placebo Comparator: Plasebo

Interventions

Other: - Fecal Microbiota Transplantation

FMT via colonoscopy

Other: - Placebo

Water infusion via colonoscopy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tampere University Hospital, Tampere, Finland

Status

Recruiting

Address

Tampere University Hospital

Tampere, , 33521

Tampere University Hospital, Tampere, Finland

Status

Recruiting

Address

Tampere University Hospital

Tampere, , 33521

Site Contact

Elina M Jokinen, PhD

elina.jokinen@pshp.fi

+3583311611