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The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation

NCT03621657 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-03-15

Study results available
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Summary

The primary objective of this study is to compare the gut microbiota and clinical outcomes of oral FMT during antibiotic treatment, immediately following antibiotic treatment, and placebo. The second objective is to assess the safety and feasibility of daily oral Fecal Microbiome Transplant (FMT) as a treatment option.

Conditions

  • Clostridium Difficile Infection
  • C.Difficile Diarrhea
  • CDI

Interventions

DRUG

Low Dose FMT Capsule DE

5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course.

DRUG

Single Dose FMT Capsule DE

30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment.

DRUG

Placebo oral capsule

Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Nasia Safdar, MD, PhD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2020-02-27
Completion
2020-02-27
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 NCT03621657 on ClinicalTrials.gov