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Virus Therapy

Fecal Microbiota Transplant for Clostridium Difficile Infection

Phase 4
Waitlist Available
Led By Muhammad Memon, MD
Research Sponsored by Methodist Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Vancomycin
At least two episodes of severe C diff infection that have required hospitalization and significant morbidity within one year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up eight weeks following transplant.
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of FMT for recurrent CDI.

Who is the study for?
This trial is for patients who've had at least three mild to moderate or two severe Clostridium difficile infections that didn't get better with standard treatments. It's not for those with recent bone marrow transplants, advanced liver disease, late-stage HIV/AIDS, immune suppression from medications (unless the doctor approves), pregnancy, or certain serious intestinal conditions.Check my eligibility
What is being tested?
The study tests Fecal Microbiota Transplant (FMT) effectiveness in treating recurrent C. difficile infection by transferring healthy gut bacteria from a screened donor into the patient's colon. The goal is to restore beneficial bacteria and reduce both health costs and physical burden of CDI.See study design
What are the potential side effects?
While specific side effects are not listed here, FMT procedures may cause discomfort during administration and potential risks include transmission of infectious agents or adverse reactions related to gut flora changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently taking or have taken Vancomycin.
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I've been hospitalized twice for severe C diff infection in the past year.
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I have a severe C Diff infection that didn't improve with medication and needed hospital care.
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I have had C Diff infection 3 times and treatments haven't worked.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eight weeks following transplant.
This trial's timeline: 3 weeks for screening, Varies for treatment, and eight weeks following transplant. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
material volume
repeat transplant, colectomy and antibiotics
serious adverse reactions
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Clostridium difficile infectionExperimental Treatment1 Intervention
Clostridium difficile infection (CDI) is due to a toxin-producing bacteria that causes a more severe form of antibiotic associated diarrhea. The disease ranges from mild diarrhea to severe colon inflammation that can even be fatal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplant
2021
Completed Phase 4
~190

Find a Location

Who is running the clinical trial?

Methodist Health SystemLead Sponsor
152 Previous Clinical Trials
4,825,609 Total Patients Enrolled
Muhammad Memon, MDPrincipal InvestigatorMethodist Mansfield Medical Center
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Fecal Microbiota Transplant (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04090346 — Phase 4
Clostridium Difficile Infection Research Study Groups: Clostridium difficile infection
Clostridium Difficile Infection Clinical Trial 2023: Fecal Microbiota Transplant Highlights & Side Effects. Trial Name: NCT04090346 — Phase 4
Fecal Microbiota Transplant (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04090346 — Phase 4

Frequently Asked Questions

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

What security measures are in place to ensure patient safety with Fecal Microbiota Transplant?

"There is ample evidence that Fecal Microbiota Transplantation has already been approved, thus it earns a score of 3 on the safety scale."

Answered by AI

Are people still being accepted for participation in this experiment?

"Data available on clinicaltrials.gov confirms that this research project, which began on June 5th 2018 and was last updated November 9th 2021, is not actively recruiting patients. Fortunately, there are 42 other trials currently accepting applicants."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Fecal Microbiota Transplant
2018. "Fecal Microbiota Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04090346.
~3 spots leftby May 2025
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