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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

Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I've been hospitalized for a severe C. diff infection that didn't improve with antibiotics.

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I have had C. difficile infection recur at least twice after treatment.

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I have tried and not responded to standard treatments like metronidazole or vancomycin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Vomiting

Fatigue

Heart Burn

Chills

Migraine

Yeast Infection

Anemia

IBD Flare

100%

80%

60%

40%

20%

Study treatment Arm

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

2016

Completed Phase 2

~350

0 / 3Eligibility criteria met

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

Frequently Asked Questions

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

What is the population size of participants in this experimental research?

"Affirmative. According to clinicaltrials.gov, this investigation is actively seeking participants. The trial was initially listed on January 16th 2014 and more recently updated on October 3rd 2021; it needs 500 people at one medical facility to contribute data."

Answered by AI

Are there any vacancies available for participants of this research study?

"Indeed, this medical study is currently welcoming participants. Clinicaltrials.gov states that the trial was first published on January 16th 2014 and its most recent update occured on October 3rd 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile

Krunal Patel 2014. "Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03562741.

All > Clostridium Difficile