← Back to Search

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
Need for colonoscopy
Age: 7-21 who have been diagnosed with ulcerative colitis
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You require a colonoscopy.
Select...
You are between the ages of 7 and 21 and have been diagnosed with 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
229 Previous Clinical Trials
5,076,241 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to take part in this clinical exploration?

"This medical experiment is recruiting 101 individuals aged 7 to 21 with a mild to moderate case of ulcerative colitis, based on their PUCAI score ranging from 10-64. Additionally, these participants must be willing and able to have a colonoscopy conducted."

Answered by AI

Are elderly individuals eligible to partake in this scientific experiment?

"Patients aged between 7 and 21 qualify for enrollment in this clinical trial. On the other hand, there are 70 medical studies exclusively for minors below 18 years old, as well as 347 trials designed to serve those 65 or older."

Answered by AI

What are the security implications of Donor Stool Transplant for individuals?

"The safety rating of Donor Stool Transplantation is assessed as a 1, due to the preliminary nature of this Phase 1 trial which does not have extensive evidence for either its efficacy or security."

Answered by AI

Does the recruitment period for this research endeavor remain open?

"Contrary to expectation, clinicaltrials.gov documents indicate that this medical investigation is not currently recruiting patients; the trial was initially published on November 1st 2016 and last amended on January 30th 2022. Despite this, there are still 408 other trials presently searching for participants."

Answered by AI
Recent research and studies
~12 spots leftby Mar 2025