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Fecal Microbial Transplant

Donor Stool Transplant for Ulcerative Colitis (FMT_UC Trial)

Phase 1
Waitlist Available
Led By Sonia Michail, MD
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

FMT_UC Trial Summary

This trial will test the safety and effectiveness of a new medication for ulcerative colitis.

Eligible Conditions
  • Ulcerative Colitis

FMT_UC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary endpoint is disease remission based on PUCAI scores (<10).
Secondary outcome measures
Secondary endpoints will include change in mucosal inflammation reflected on laboratory studies.

FMT_UC Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Donor Stool TransplantActive Control1 Intervention
Arm 2 will get FMT (Fecal Microbial Transplant) with Healthy Donor Stool and high dose 5-ASA (Pentasa). The FMT is done through colonoscopy.
Group II: Patient Stool TransplantPlacebo Group1 Intervention
Arm 1 will get FMT (Fecal Microbial Transplant) placebo and high dose 5-ASA (Pentasa). The FMT is done through colonoscopy.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor
236 Previous Clinical Trials
5,076,995 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
10 Patients Enrolled for Ulcerative Colitis
Sonia Michail, MDPrincipal Investigator - Children Hospital Los Angeles
Children's Hospital Los Angeles
Ain Shams University (Medical School)
University Of Ne Medical Center (Residency)
5 Previous Clinical Trials
53 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
10 Patients Enrolled for Ulcerative Colitis

Media Library

Fecal Microbial Transplant (Fecal Microbial Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT02291523 — Phase 1
Ulcerative Colitis Research Study Groups: Patient Stool Transplant, Donor Stool Transplant
Ulcerative Colitis Clinical Trial 2023: Fecal Microbial Transplant Highlights & Side Effects. Trial Name: NCT02291523 — Phase 1
Fecal Microbial Transplant (Fecal Microbial Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02291523 — Phase 1
~12 spots leftby Jun 2025
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