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Microbiota Restoration

Fecal Microbiota Transplantation for C. diff Infection

N/A
Recruiting
Research Sponsored by Krunal Patel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity
Failed standard therapy with oral metronidazole and/or oral vancomycin
Must not have
Age <16 years old
patients with acute severe colonic dilation at risk for colonic perforation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether stool transplant can effectively treat recurrent C. diff infection by replenishing good bacteria in the colon.

Who is the study for?
This trial is for people who've had at least two recurrences of C. diff infection, with symptoms coming back within 2-8 weeks after treatment. It's also for those whose severe C. diff led to hospitalization and didn't improve with standard antibiotics. Participants must be over 16 and not at risk of colon perforation.
What is being tested?
The study tests fecal microbiota transplantation (FMT) via colonoscopy to treat recurrent C. diff infections by transferring stool from a healthy donor into the patient's colon, aiming to restore beneficial bacteria.
What are the potential side effects?
Potential side effects may include discomfort or pain from the colonoscopy procedure, bloating, changes in bowel habits, and risks associated with gut flora alteration such as new infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've been hospitalized for a severe C. diff infection that didn't improve with antibiotics.
Select...
I have tried and not responded to standard treatments like metronidazole or vancomycin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am younger than 16 years old.
Select...
I am at risk for a tear in my colon due to severe swelling.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clostridium Difficile (C. diff) resolution'

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%
Fatigue
6%
Vomiting
4%
Heart Burn
4%
Chills
4%
Yeast Infection
4%
Migraine
2%
Anemia
2%
IBD Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota TransplantationExperimental Treatment1 Intervention
Subjects receive intervention of stool transplanted to the colon via colonoscopy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation
2020
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

Krunal PatelLead Sponsor

Media Library

Fecal Microbiota Transplantation (Microbiota Restoration) Clinical Trial Eligibility Overview. Trial Name: NCT03562741 — N/A
Clostridium Difficile Infection Research Study Groups: Fecal Microbiota Transplantation
Clostridium Difficile Infection Clinical Trial 2023: Fecal Microbiota Transplantation Highlights & Side Effects. Trial Name: NCT03562741 — N/A
Fecal Microbiota Transplantation (Microbiota Restoration) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03562741 — N/A
~42 spots leftby Jan 2026
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