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NCT03948919 · ClinicalTrials.gov registry record · Phase 1

Fecal Transplant for Ulcerative Colitis

A Phase 1 study of Ulcerative Colitis, sponsored by University of Minnesota.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target
1
Study location

NCT03948919 is a Phase 1 study of Ulcerative Colitis that has completed, run by University of Minnesota. The registered enrollment target is 26 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03948919, a Phase 1 study of Ulcerative Colitis, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate the engraftment of donor microbiota with active ulcerative colitis (UC) following sequential fecal microbiota transplant (FMT). One key group of bacteria we are following are sulfate reducing bacteria (SRB). We plan to measure the relative abundance of SRB at baseline and after FMT. It is widely unknown if the microbiota in UC is dysfunctional and therefore perpetuates inflammation, or if the ongoing inflammation shapes the microbiota. We aim to determine if we can alter the microbiota in UC towards a healthy, more diverse microbiota resembling the donor using capsule FMT material.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Fecal microbiota

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2019-07-31
Est. Completion 2024-01-04
Phase Phase 1

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT03948919

The ClinicalTrials.gov registry entry for NCT03948919 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03948919 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT03948919 about?

NCT03948919 is a clinical study titled "Fecal Transplant for Ulcerative Colitis". The purpose of this study is to evaluate the engraftment of donor microbiota with active ulcerative colitis (UC) following sequential fecal microbiota transplant (FMT). One key group of bacteria we are following are sulfate reducing bacteria (SRB). We plan to measure the relative abundance of SRB at...

What is the current status of trial NCT03948919?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2019-07-31. Estimated completion is 2024-01-04.

What conditions does trial NCT03948919 study?

This clinical trial studies the following conditions: Ulcerative Colitis.

What interventions are being tested in trial NCT03948919?

The interventions under investigation include: Placebo (DRUG), Fecal microbiota (DRUG).

Who is sponsoring clinical trial NCT03948919?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03948919 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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