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Fecal Microbial Transplant

Donor Stool Transplant for 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

Summary

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

Eligible Conditions
  • Colitis

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

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

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
248 Previous Clinical Trials
5,074,523 Total Patients Enrolled
1 Trials studying Colitis
10 Patients Enrolled for 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
2 Trials studying Colitis
19 Patients Enrolled for Colitis

Media Library

Fecal Microbial Transplant (Fecal Microbial Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT02291523 — Phase 1
Colitis Research Study Groups: Patient Stool Transplant, Donor Stool Transplant
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
~11 spots leftby Nov 2025
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