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Fecal Microbiota Transplantation in Postoperative Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04637438
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : October 27, 2022
Sponsor:
Collaborators:
Turku University Hospital
Joint Authority for Päijät-Häme Social and Health Care
Kuopio University Hospital
Helsinki University Central Hospital
Tampere University
Information provided by (Responsible Party):
Elina Jokinen, Tampere University Hospital

Study Description
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Brief 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. With microbiota analysis we aim to assess if changes in gut microbiota are related to disease course of CD after operation.

Condition or disease Intervention/treatment Phase
Crohn Disease Other: Fecal Microbiota Transplantation Other: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fecal Microbiota Transplantation in Postoperative Crohn's Disease
Actual Study Start Date : May 18, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Fecal Microbiota Transplantation Other: Fecal Microbiota Transplantation
FMT via colonoscopy
Placebo Comparator: Plasebo Other: Placebo
Water infusion via colonoscopy


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Safety of FMT using FinFMT-Questionnaire [ Time Frame: 3 months, 12 months, 5 years ]
    Unvalidated survey including 20 questions.

  2. 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.


  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. F-calpro microg/g [ Time Frame: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years ]
    Median in intervention group versus plasebo group

  10. Hb mg/l [ Time Frame: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years ]
    Median in intervention group versus plasebo group


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04637438


Contacts
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Contact: Elina Jokinen, PhD +3583311611 elina.jokinen@pshp.fi

Locations
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Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Elina M Jokinen, PhD       elina.jokinen@pshp.fi   
Sponsors and Collaborators
Tampere University Hospital
Turku University Hospital
Joint Authority for Päijät-Häme Social and Health Care
Kuopio University Hospital
Helsinki University Central Hospital
Tampere University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Elina Jokinen, Doctor of Medical Science, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT04637438    
Other Study ID Numbers: R20041
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elina Jokinen, Tampere University Hospital:
Fecal Microbiota Transplantation
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases