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Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis

NCT03006809 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-28

No results posted yet for this study

Summary

This is a prospective unblinded, randomized trial for the use of Fecal Microbiota Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or without antibiotic pretreatment.

Conditions

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation (FMT), OpenBiome

Delivered by colonoscopy, enema or orally (as capsules)

OTHER

pretreatment antibiotics

5 day course (vancomycin PO 500mg bid, metronidazole PO 500mg bid, and neomycin PO 500mg bid) starting 6 days prior FMT

Sponsors & Collaborators

  • Najwa Elnachef

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-02
Primary Completion
2020-05-04
Completion
2021-04-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03006809 on ClinicalTrials.gov