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Microbiota Transplantation
Fecal Microbiota Transplantation for Clostridioides difficile Colitis
Phase 1
Waitlist Available
Led By David Y Graham, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
VA patients with confirmed diagnosis of CDI treated with metronidazole or vancomycin
Diagnosis confirmed by presence of diarrhea and abdominal discomfort
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial is to confirm and extend the work of Trede and Rask-Madsen that administration of a defined fecal microbiota will lead to rapid and sustained resolution of C. difficile associated chronic relapsing diarrhea.
Who is the study for?
This trial is for VA patients with confirmed C. difficile infection (CDI) that persists or returns after standard treatment. They must be able to give informed consent and not have severe kidney issues, active serious cancer, HIV/AIDS, be bedridden, on high-dose steroids or other strong immune-suppressing drugs, have advanced liver disease, need certain concurrent antibiotics, or have a life expectancy under one year.Check my eligibility
What is being tested?
The study tests fecal microbiota transplantation (FMT), which involves transferring stool from a healthy donor to the patient's intestine to restore normal gut bacteria balance. This could suppress C. difficile growth and alleviate chronic diarrhea associated with CDI.See study design
What are the potential side effects?
In the limited number of patients treated so far in this study there were no adverse events reported post-FMT. Generally speaking though FMT can sometimes cause temporary digestive discomfort such as bloating and gas.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a veteran diagnosed with CDI and treated with metronidazole or vancomycin.
Select...
I have been diagnosed with a condition causing diarrhea and abdominal discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Binomial: success defined as resolution or no resolution of disease. Resolution is defined as either complete cessation of clinical symptoms or diagnostic confirmation of the absence of disease, during the period of follow-up after transplantation.
Trial Design
1Treatment groups
Experimental Treatment
Group I: microbiota transplantationExperimental Treatment1 Intervention
Two hundred mL of the bacterial suspension (microbiota transplantation) will be instilled into the small intestine via a catheter introduced through the biopsy channel of the endoscope and the flushed with 25 mL of sterile pre-reduced 0.9% saline. After removal of the endoscope, after recovery, patients will be allowed to resume a normal diet and physical activities.
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,240 Total Patients Enrolled
Michael E. DeBakey VA Medical CenterFED
64 Previous Clinical Trials
15,776 Total Patients Enrolled
Antone R Opekun, MS, PA-CStudy DirectorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is severely impaired.I have an active cancer that is not just on the skin's surface.My liver is severely damaged and cannot function properly.I am currently taking or have taken chemotherapy drugs.I have HIV/AIDS.I recently had a bone marrow transplant or have a severe immune system problem.I am currently taking strong medications to suppress my immune system.I am a veteran diagnosed with CDI and treated with metronidazole or vancomycin.I am unable to get out of bed by myself.I need to take medicine to fight an infection.I have been diagnosed with a condition causing diarrhea and abdominal discomfort.My condition worsened or didn't improve within 4 weeks after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: microbiota transplantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this undergone the FDA's approval process?
"This new treatment has only been tested on a limited number of patients, so it received a score of 1 for safety."
Answered by AI
Are there any positions left for prospective participants in this research?
"Based on a review of the information available on clinicaltrials.gov, it appears that this particular medical trial is not currently looking for new participants. The study was initially posted on 2/28/2013 and was last updated on 2/24/2022. However, there are 283 other clinical trials that are presently recruiting patients."
Answered by AI
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