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Microbiome Restoration

Fecal Microbiota Transplantation (FMT) for Antibiotic Resistance

N/A

Waitlist Available

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing whether a fecal microbiota transplant can eliminate highly drug-resistant bacteria from the intestinal tract of renal transplant patients. The goal is to test whether this will prevent difficult to treat post-transplant infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years 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 elimination of the target multi-drug resistant organism (MDRO), using culture and molecular test-based screening of recipient stool, at both the 14 and 30 days post-FMT.

Secondary outcome measures

Compare proportions, type and timing of adverse events post-FMT

Proportions of recolonization over 180 days

Timing of recolonization over 180 days

Side effects data

From 2016 Phase 1 trial • 23 Patients • NCT02108821

48%

Abdominal Pain

22%

Flatulence and bloating

22%

Diarrhea

13%

Emesis

Bloody stools

Nausea

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Fecal Microbiota Transplantation

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Fecal microbiota transplantation with antibiotic pre-treatmentExperimental Treatment1 Intervention

Group II: Fecal microbiota transplantationExperimental Treatment1 Intervention

Group III: No intervention follow-upActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fecal Microbiota Transplantation (FMT)

2016

Completed Phase 1

~170

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,422 Previous Clinical Trials

2,468,283 Total Patients Enrolled

Media Library

Fecal Microbiota Transplantation (FMT) (Microbiome Restoration) Clinical Trial Eligibility Overview. Trial Name: NCT04181112 — N/A

Antibiotic Resistance Research Study Groups: No intervention follow-up, Fecal microbiota transplantation, Fecal microbiota transplantation with antibiotic pre-treatment

Antibiotic Resistance Clinical Trial 2023: Fecal Microbiota Transplantation (FMT) Highlights & Side Effects. Trial Name: NCT04181112 — N/A

Fecal Microbiota Transplantation (FMT) (Microbiome Restoration) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04181112 — N/A

Frequently Asked Questions

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

Are there any remaining opportunities for enrollment in this experiment?

"Yes, according to clinicaltrials.gov this medical trial is still accepting enrolment from participants. It was initially posted on November 4th 2019 and its most recent update was October 4th 2021. The study requires 90 patients across a single site for completion."

Answered by AI

What is the estimated participant count for this experiment?

"Indeed, clinicaltrials.gov shows that this medical study is currently enrolling applicants. It was first published on November 4th 2019 and most recently updated October 4th 2021. The trial seeks to recruit 90 patients from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fecal Transplant for MDRO Decolonization

Amee Manges 2019. "Fecal Transplant for MDRO Decolonization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04181112.