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Trial record 2 of 33 for:    IBD | Recruiting Studies | fecal microbiota transplantation

Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

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ClinicalTrials.gov Identifier: NCT03399188
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in IBD patients.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Procedure: Fecal microbiome transplantation Not Applicable

Detailed Description:

Fecal microbiota transplantation will be performed to the IBD patients, and microbial analysis will be done for donor and recipient feces. Fecal microbiota transplantation will be done twice via colonoscopy, with one month of duration. During the early stage of Fecal microbiota transplantation, recipient feces will be analyzed for the intestinal microbiota frequently.

Clinical outcome will be assessed 1month, 2month, 6month, and 1 year after the transplantation.

Relevance of intestinal microbial change and clinical outcome after transplantation and factors associated with successful clinical outcome will be investigated.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Inflammatory bowel disease patients in active stage.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: FMT group
Group who received fecal microbiome transplantation
Procedure: Fecal microbiome transplantation
Fecal microbiota transplantation will be performed through colonoscopy to the IBD patients. Donor feces will be extensively screened for other diseases. Colonoscopy will be done at FMT center of Severance Children's Hospital twice with a month of duration. Recipients will be admitted the day before colonoscopy, and they will be discharged after a day of observation.




Primary Outcome Measures :
  1. Clinical remission [ Time Frame: 6months after the Second FMT ]

    For Ulcerative Colitis patients Patients 18 years old and under: Pediatric ulcerative colitis activity index (PUCAI) less than 10.

    It ranges from 0 to 85, with a higher score indicating greater severity of disease Patients over 18 years old: Partial Mayo score same or less than 1 It ranges from 0 to 9, with a higher score indicating greater severity of disease For Crohn's Disease patients Patients 18 years old and under: Pediatric Crohn's disease activity index (PCDAI) less than 10 It ranges from 0 to 100, with a higher score indicating greater severity of disease Patients over 18 years old: Crohn's disease activity index (CDAI) less than 150 It ranges from 0 to over 600, with a higher score indicating greater severity of disease



Secondary Outcome Measures :
  1. Microbiome analysis by using relative abundance at phylum and genus level, beta diversity [ Time Frame: Before, day 0~28 of 1st FMT, day 0~28, 60, 90, 180 of 2nd FMT ]
    • Microbial changes (increase of microbial diversity and improvement of firmicutes/bacteriodes ratio) in an early stage after FMT by using Relative abundance at phylum and genus level
    • Microbial stability after FMT for one week (change in beta diversity)

  2. Clinical response using disease activity index [ Time Frame: 6 months after the Second FMT ]
  3. Endoscopic healing [ Time Frame: 4 weeks after the First FMT ]
  4. Adverse events [ Time Frame: 6 months after the Second FMT ]
    Any adverse events thought to be related to FMT will be measured throughout the follow-up period after FMT.



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Ages Eligible for Study:   7 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 7 years old to 80 years old at start of trial
  • Inflammatory bowel disease such as ulcerative colitis, Crohn's disease, and Behcet's colitis
  • Patients who do not respond to the conventional treatments or who do not wish/not able to use one.
  • Patients who agree to participate in the trial after thorough explanation
  • Evidence of active disease

Exclusion Criteria:

  • Patients whose CRP<8, calprotectin<200, and mucosal healing endoscopically (who are in stable state)
  • Patients whose symptom is due to other disease than IBD

    _Patients with immunosuppressive disease

  • Patients who are clinically unstable such as massive hemorrhage or perforation
  • Patients with toxic megacolon, paralytic ileus, or symptomatic intestinal obstruction
  • Absolute neutrophil count (ANC) <1.5 *10^9/L (1500/mm3)
  • Pregnant or under breast feeding
  • Patients enrolled in other clinical trials

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): NCT03399188


Locations
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Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: Hong Koh    82-2-2227-2050    khong@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03399188     History of Changes
Other Study ID Numbers: 4-2017-0223
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Yonsei University:
Inflammatory Bowel Diseases, Fecal microbiota transplantation, microbiome
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis