Fecal Microbiota Transplantation in Postoperative Crohn's Disease

October 24, 2022 updated by: Elina Jokinen, Tampere University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Fecal Microbiota Transplantation
Other: Fecal Microbiota Transplantation
FMT via colonoscopy
Placebo Comparator: Plasebo
Other: Placebo
Water infusion via colonoscopy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in endoscopic Rutgeerts score between first and second colonoscopy
Time Frame: 1 year
Rutgeerts endoscopic score ranges from i0 indicating remission to i4 indicating severe post-operative relapse. Cut off value > i1 will be used to compare number on patients in intervention group and in placebo group.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety of FMT using FinFMT-Questionnaire
Time Frame: 3 months, 12 months, 5 years
Unvalidated survey including 20 questions.
3 months, 12 months, 5 years
Clinical activity of Crohn's disease using Harwey-Bradshaw Index
Time Frame: 6 months, 12 months, 5 years

Scores of less that 5 indicate that the patient's Crohn's disease is in remission while scores higher than 16 indicate severe disease activity.

Median scores will be compared between intervention group and placebo group.
6 months, 12 months, 5 years
Histologic activity of Crohn's Disease using modified Global Histological Activity Score
Time Frame: 1 years, 5 years
The GHAS consists of eight items assessing acute and chronic inflammatory changes, epithelial damage and the extent of inflammation (i.e. the proportion of biopsy specimens affected). Each of the eight items is scored, with the totals subsequently added together. Maximum number 14 indicates histological activity. The median GHAS score will be compared between intervention group and placebo group.
1 years, 5 years
Change of microbiota in stool samples and in intestinal biopsies
Time Frame: 6 weeks,12 weeks, 48 weeks, 5 years
The relative abundances of taxonomic units in cases versus controls and different time points will be compared at the level of phylum, class, genus, species and OTU. Alpha diversity measures will be determined from the original unfiltered dataset by counting observed taxa (OTU richness) and by Chao1, ACE, Shannon, Simpson and Fisher indices; diversity will be compared between time points.cases and controls. Beta diversity will be assessed by examining the results of principle component analysis using multiple distance methods, if appreciable difference between cases and controls or time points will be noted, formal testing of clustering will be performed. To simplify complex bacteriome profiles, we will also sort each sample into enterotypes based on the leading components of their bacteriomes; the enterotypes will be tested as a predictor of the case-control or disease status of cases.
6 weeks,12 weeks, 48 weeks, 5 years
Patient reported outcome
Time Frame: 12 weeks, 48 weeks,years 5
IBD symptom index (IBD-SI) questionnaire. Minimum number of points 0 indicating remission, maximum number of points 15 indicating active disease or flare.
12 weeks, 48 weeks,years 5
Change in inflammatory marker CRP mg/l
Time Frame: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Median in intervention group versus plasebo group
6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Need for hospitalization
Time Frame: Through study completion, an avarage of 1 year and 5 years
Avarage number of days spent in hospital in intervention group vs. plasebo group
Through study completion, an avarage of 1 year and 5 years
Need for treatment escalation
Time Frame: Through study completion, an avarage of 1 year and 5 years
Number of patients needing treatment escalation from thiopurines to TNF alfa blockers in intervention group versus plasebo group
Through study completion, an avarage of 1 year and 5 years
F-calpro microg/g
Time Frame: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Median in intervention group versus plasebo group
6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Hb mg/l
Time Frame: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Median in intervention group versus plasebo group
6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tampere University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Turku University Hospital
Helsinki University Central Hospital
Kuopio University Hospital
Tampere University
Joint Authority for Päijät-Häme Social and Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R20041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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