Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

NCT03399188 | Unknown

• 1 other identifier: 4-2017-0223
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammatory Bowel Diseases

Keywords

Inflammatory Bowel Diseases, Fecal microbiota transplantation, microbiome

Outcome Measures

Primary Outcomes (1)

• Clinical remission

  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

  6months after the Second FMT

Secondary Outcomes (4)

• Microbiome analysis by using relative abundance at phylum and genus level, beta diversity

  Before, day 0~28 of 1st FMT, day 0~28, 60, 90, 180 of 2nd FMT

• Clinical response using disease activity index

  6 months after the Second FMT

• Endoscopic healing

  4 weeks after the First FMT

• Adverse events

  6 months after the Second FMT

Study Arms (1)

FMT group

EXPERIMENTAL

Group who received fecal microbiome transplantation

Procedure: Fecal microbiome transplantation

Interventions

Fecal microbiome transplantation PROCEDURE

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.

FMT group

Eligibility Criteria

• Age: 7 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Inflammatory bowel disease patients in active stage.

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 16, 2018
• Study Start: November 15, 2017
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

KR (1)