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Randomized Trial Comparing Single vs. Maintenance Fecal Microbiota Transplant for Refractory Crohn's Disease in Children

NCT03747718 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-04-14

No results posted yet for this study

Summary

NCT02108821

Primary goal:

-To determine the safety of fecal transplant by colonoscopy and retention enemas for induction followed by maintenance retention fecal vs. placebo enemas in children and young adults with uncomplicated mild-moderately active Crohn's disease.

Secondary goals:

* Assess efficacy of this induction regimen followed by maintenance fecal or placebo transplants in responders. The efficacy will be assessed by clinical evaluation and fecal calprotectin that is a non-invasive biomarker.
* Correlate subject's baseline microbiome findings with likelihood for response to FMT induction therapy.
* Follow the chronological microbiome shifts after transplant and correlate with response using clinical and calprotectin assessment in the two groups.

Conditions

  • Crohn Disease

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation

Fecal Microbiota Transplantation via colonoscopy for the first transplant in all subjects. This will be followed by 2 fecal enema transplants for all subjects 7 days (+/- 3 days) after colonoscopy. All subjects will be assessed 1.5 months (+/- 2 weeks) after colonoscopy. The subjects who are deemed responders based on a drop in PCDAI=12.5 or higher will be randomized to receive fecal or placebo enemas at 1 monthly (+/- 2 weeks) enemas at 1.5, 2.5 and 3.5 months after colonoscopy. All subjects will be assessed at 4.5 and 6 months (+/- 2 weeks) following colonoscopy. The study will be completed at 6 months (+/- 2 weeks) following colonoscopy.

OTHER

Placebo

Fecal Microbiota Transplantation via colonoscopy for the first transplant in all subjects. This will be followed by 2 fecal enema transplants for all subjects 7 days (+/- 3 days) after colonoscopy. All subjects will be assessed 1.5 months (+/- 2 weeks) after colonoscopy. The subjects who are deemed responders based on a drop in PCDAI=12.5 or higher will be randomized to receive fecal or placebo enemas at 1 monthly (+/- 2 weeks) enemas at 1.5, 2.5 and 3.5 months after colonoscopy. All subjects will be assessed at 4.5 and 6 months (+/- 2 weeks) following colonoscopy. The study will be completed at 6 months (+/- 2 weeks) following colonoscopy.

Sponsors & Collaborators

Principal Investigators

  • Alka Goyal, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
2 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-12-01
Completion
2025-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03747718 on ClinicalTrials.gov