Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease

NCT04436874 | Unknown DMC

• 1 other identifier: FMT-IBD-190923
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use.

Conditions

Fecal Microbiota Transplantation

Keywords

Ulcerative Colitis; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• steroid-free clinical remission and endoscopic remission

  The primary outcome is a composite of steroid-free clinical remission together with endoscopic remission or response at week 6, defined as defined as a total Mayo score of ≤2 points with no individual sub-score \>1 point, and at least a 1 point reduction from baseline in the endoscopy sub-score

  3 years

Secondary Outcomes (10)

• Steroid-free clinical remission

  3 years

• Steroid-free clinical response

  3 years

• Steroid-free endoscopic response

  3 years

• microbiological change

  3 years

• Change in microbiome of stool

  3 years

Study Arms (4)

Han ethnic-UC

EXPERIMENTAL

Ulcerative colitis subjects will be treated with bacterial solution from Han ethnic by endoscopy

Device: endoscopy

Han ethnic-CD

EXPERIMENTAL

Crohn's disease subjects will be treated with bacterial solution from Han ethnic by endoscopy

Device: endoscopy

Dai ethnic-UC

EXPERIMENTAL

Ulcerative colitis subjects will be treated with bacterial solution from Dai ethnic by endoscopy

Device: endoscopy

Dai ethnic-CD

EXPERIMENTAL

Crohn's disease subjects will be treated with bacterial solution from Dai ethnic by endoscopy

Device: endoscopy

Interventions

endoscopy DEVICE

transplant infusion of feces from healthy donors into affected subjects

Dai ethnic-CD; Dai ethnic-UC; Han ethnic-CD; Han ethnic-UC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years inclusive (no limit on gender)
• Confirmed diagnosis of ulcerative colitis for \> 3 months, according to established clinical,endoscopic and histologic criteria
• Currently active mild-moderate ulcerative colitis, as measured by a Mayo score of 4-10, in which endoscopy sub-score ≥ 1 and physician's global assessment sub-score ≤ 2
• Written informed consent obtained.

You may not qualify if:

• Subjects who are unable to give consent or who have conditions rendering them incapable to answer questionnaires or provide samples.
• Females who are pregnant or actively trying to fall pregnant
• Subjects unwilling to practice an effective method of contraception throughout the study period
• Subjects defined as in remission by the investigator
• Evidence or history of toxic megacolon
• Isolated proctitis \< 5 cm
• A diagnosis of Crohn's Disease or indeterminate colitis
• Subjects with perianal disease (e.g. fistulae, pre-existing fissures)
• Significant gastrointestinal surgery e.g. colon resection, colectomy :Minor gastrointestinal surgery will be reviewed on a case by case basis by the investigator;Regarding appendicectomy, only exclude patients who had appendicectomy \< 3 months ago)
• Subjects taking antimicrobials (antibiotics, antifungals, antivirals) for any reason, including antibiotics for ulcerative colitis, in the preceding 4 weeks
• Subjects who are steroid dependent and requiring \> 20mg prednisone or \> 9mg budesonide daily at the time of enrolment
• Subjects who have recently taken or are actively taking or expected to require prohibited medication/s during the study period including follow-up. These include:Rectal therapy including corticosteroid, 5-aminosalicylate within 2 weeks before first FMT;Treatment with biologic agents e.g. infliximab, adalimumab, vedolizumab, within 12 weeks before first FMT;Treatment with other major immunosuppressant agents including calcineurin inhibitors, anti-neoplastic agents, lymphocyte depleting biological agents within 12 weeks before first FMT;Probiotic therapy within 4 weeks before first FMT;Experimental / trial drug protocol involvement within 12 weeks before first FMT;Anti-mycobacterial (TB or MAC) therapy within 4 weeks before first FMT
• Allowed concomitant medications:
• The following drugs are allowed as long as the dose is stable preceding first FMT for the noted time:
• oral 5-aminosalicylates (stable dose for 4 weeks)

Sponsors & Collaborators

• First Affiliated Hospital of Kunming Medical University: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Endoscopy

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Y L Miao, doctor

  First Affiliated Hospital of Kunming Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor，Director of Gastroenterology

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 18, 2020
• Study Start: September 23, 2019
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2022
• Last Updated: June 19, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)