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Microbiome Therapy

Fecal Transplant for C-diff Infection (FMT Trial)

Phase 1
Recruiting
Led By Jonathan M. Gisser, M.D.
Research Sponsored by Jonathan Gisser
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No antibiotic use within the last 90 days
≥ 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months post transplant
Awards & highlights

FMT Trial Summary

This trial is testing whether a fecal transplant can help treat children with C-diff infection who have not gotten better with other medicines.

Who is the study for?
This trial is for children and young adults aged 2 to less than 21 years with recurrent C-diff infection, who are undergoing a colonoscopy. Participants must have had at least three episodes of this infection. Healthy first-degree relatives over 18 can be donors, but they shouldn't have taken antibiotics recently or have any listed health issues.Check my eligibility
What is being tested?
The study tests fecal microbiota transplantation (FMT) in pediatric patients with recurrent C-diff infections. FMT involves transferring stool from a healthy donor into the patient's colon to balance the bacteria and combat the infection.See study design
What are the potential side effects?
Potential side effects may include discomfort at the transplant site, abdominal pain, bloating, diarrhea or constipation following the procedure. There might also be risks related to sedation for colonoscopy.

FMT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't taken antibiotics in the last 3 months.
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I am 18 years old or older.
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I have had c-diff infection three or more times.
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I am currently experiencing diarrhea.

FMT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post 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
Resolution of C. difficile
Secondary outcome measures
Adverse events

Side effects data

From 2020 Phase 1 & 2 trial • 50 Patients • NCT03106844
44%
Diarrhea
26%
Abdominal Pain
16%
Rectal Bleeding
12%
Constiption
10%
Fever
10%
Nausea
6%
Vomiting
6%
Fatigue
4%
Heart Burn
4%
Chills
4%
Migraine
4%
Yeast Infection
2%
Anemia
2%
IBD Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment

FMT Trial Design

1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota TransplantationExperimental Treatment1 Intervention
250 ml of a fecal suspension diluted in saline given by colonoscopy or enema.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation
2016
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Jonathan GisserLead Sponsor
Jonathan M. Gisser, M.D.Principal InvestigatorNationwide Children's Hospital

Media Library

Fecal Microbiota Transplantation (Microbiome Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02134392 — Phase 1
Clostridium Difficile Research Study Groups: Fecal Microbiota Transplantation
Clostridium Difficile Clinical Trial 2023: Fecal Microbiota Transplantation Highlights & Side Effects. Trial Name: NCT02134392 — Phase 1
Fecal Microbiota Transplantation (Microbiome Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02134392 — Phase 1

Frequently Asked Questions

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

Are there any availability for new participants in this research?

"Data from clinicaltrials.gov suggests that this trial is still looking for enrollees. This study was originally advertised on December 1st, 2013 and received its most recent update on March 9th, 2022."

Answered by AI

Could I possibly take part in this research?

"The requirements to take part in this clinical trial are that the patient has clostridium difficile and is between 2-21 years old. So far, around 15 people have met these qualifications."

Answered by AI

If a patient is over 30 years old, are they still able to enroll in this clinical research?

"The requirements for this study's participants specify that they must be between 2 and 21 years old. Out of the 864 total trials, 213 are for children and 651 are for adults over 65."

Answered by AI

Has the FDA cleared Fecal Microbiota Transplantation for medical use?

"Fecal Microbiota Transplantation is still in Phase 1 of clinical trials, meaning that there is limited data to support its safety and efficacy. Our team at Power estimates that it scores a 1 on our safety scale."

Answered by AI

How many people are being given the opportunity to participate in this clinical trial?

"The clinicaltrials.gov website says that this trial is open for enrollment and currently looking for 15 patients at 1 locations. The study was first posted on December 1st, 2013 and was most recently edited on March 9th, 2022."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
How old are they?
65+
What site did they apply to?
GI Division, Nationwide Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Fecal Transplant for Pediatric Patients Who Have Recurrent C-diff Infection
Jonathan Gisser 2013. "Fecal Transplant for Pediatric Patients Who Have Recurrent C-diff Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02134392.
All > Clostridium Difficile > Paid Studies Ohio
~1 spots leftby Jan 2025
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