Crohn DiseaseNCT04637438
Fecal Microbiota Transplantation in Postoperative Crohn's Disease
A study testing Fecal Microbiota Transplantation in people with Crohn Disease, run by Tampere University Hospital at 2 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Fecal Microbiota Transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesFinland
- Study dates
- 18 May 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years
- Able to provide written consent
- Stricturing and/or fistulizing Crohn's disease needing ileocecal or ileal resection
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Tampere University Hospital
Tampere, 33521
- Recruiting
Tampere University Hospital
Tampere, 33521
Elina M Jokinen, PhD, elina.jokinen@pshp.fi
About this study
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.
- Conditions
- Crohn Disease
- Being tested
- Fecal Microbiota Transplantation, Placebo
- Keywords
- Fecal Microbiota Transplantation
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationOther
FMT via colonoscopy
PlaceboOther
Water infusion via colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation | Active comparator | Not described Receives: Other: Fecal Microbiota Transplantation |
| Plasebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endoscopic Rutgeerts score between first and second colonoscopy
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.
Measured: 1 year
Secondary outcomes (10)
Safety of FMT using FinFMT-Questionnaire
Unvalidated survey including 20 questions.
Measured: 3 months, 12 months, 5 years
Clinical activity of Crohn's disease using Harwey-Bradshaw Index
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.
Measured: 6 months, 12 months, 5 years
Histologic activity of Crohn's Disease using modified Global Histological Activity Score
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.
Measured: 1 years, 5 years
Change of microbiota in stool samples and in intestinal biopsies
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.
Measured: 6 weeks,12 weeks, 48 weeks, 5 years
Patient reported outcome
IBD symptom index (IBD-SI) questionnaire. Minimum number of points 0 indicating remission, maximum number of points 15 indicating active disease or flare.
Measured: 12 weeks, 48 weeks,years 5
Change in inflammatory marker CRP mg/l
Median in intervention group versus plasebo group
Measured: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Need for hospitalization
Avarage number of days spent in hospital in intervention group vs. plasebo group
Measured: Through study completion, an avarage of 1 year and 5 years
Need for treatment escalation
Number of patients needing treatment escalation from thiopurines to TNF alfa blockers in intervention group versus plasebo group
Measured: Through study completion, an avarage of 1 year and 5 years
F-calpro microg/g
Median in intervention group versus plasebo group
Measured: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Hb mg/l
Median in intervention group versus plasebo group
Measured: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start18 May 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Joint Authority for Päijät-Häme Social and Health Care, Kuopio University Hospital, Helsinki University Central Hospital, Tampere University
- Responsible party
- Principal investigator, Elina Jokinen, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637438
- Sponsor's protocol ID
- R20041
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2020
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation in Postoperative Crohn's Disease
- ClinicalTrials.gov ID
- NCT04637438
- Acronym / sponsor ID
- R20041
- Conditions
- Crohn Disease
- Keywords
- Fecal Microbiota Transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Joint Authority for Päijät-Häme Social and Health Care, Kuopio University Hospital, Helsinki University Central Hospital, Tampere University
- Study start
- 18 May 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation | Active comparator | Other: Fecal Microbiota Transplantation |
| Plasebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years
- Able to provide written consent
- Stricturing and/or fistulizing Crohn's disease needing ileocecal or ileal resection
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota TransplantationFMT via colonoscopy | Other | Fecal Microbiota Transplantation |
| PlaceboWater infusion via colonoscopy | Other | Plasebo |
Primary outcome
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.
10 secondary outcomes
Safety of FMT using FinFMT-Questionnaire
Time frame: 3 months, 12 months, 5 years
Clinical activity of Crohn's disease using Harwey-Bradshaw Index
Time frame: 6 months, 12 months, 5 years
Histologic activity of Crohn's Disease using modified Global Histological Activity Score
Time frame: 1 years, 5 years
Change of microbiota in stool samples and in intestinal biopsies
Time frame: 6 weeks,12 weeks, 48 weeks, 5 years
Patient reported outcome
Time frame: 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
Need for hospitalization
Time frame: 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
F-calpro microg/g
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation in people with Crohn Disease, run by Tampere University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elina Jokinen, PhD (+3583311611, elina.jokinen@pshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endoscopic Rutgeerts score between first and second colonoscopy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.