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Fecal Microbiota Transplant + Dietary Fiber for Graft-versus-Host Disease
Study Summary
This trial is testing how well a fecal microbiota transplant and dietary fiber supplementation work in treating patients with gut graft versus host disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I have had a blockage in my intestines before.I have had a bowel perforation in the past.I have a history of inflammatory bowel disease.I have had diverticulitis in the past.I have a severe food allergy.I have had surgery to remove part of my intestines.I have had a gastric bypass surgery.I am not pregnant, planning a pregnancy, or breastfeeding, and if capable of bearing children, I have a negative pregnancy test.The study team thinks I can't safely join the study.I had a stem cell transplant from a donor within the last 100 days.I have been diagnosed with celiac disease through blood tests or a biopsy.I have mild to severe GI issues due to a recent transplant.I am willing and able to follow all study procedures including taking oral treatments, undergoing a colonoscopy, taking fiber supplements, providing stool samples, and completing surveys.My white blood cell count has been stable for three days after a transplant.
- Group 1: Arm I (upper FMT)
- Group 2: Arm II (Lower FMT)
- Group 3: Arm III (upper FMT, fiber supplementation)
- Group 4: Arm IV (Lower FMT, fiber supplementation)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What potential hazards should a person be cognizant of upon undergoing Colonoscopy?
"Our assessment of the safety profile for colonoscopy is 1 on a scale of 1 to 3. This judgement is informed by this being an early stage trial with limited evidence supporting its efficacy and security."
Has recruitment for this experiment commenced?
"As per the information accessible on clinicaltrials.gov, this trial is not accepting participants at present. It was posted on July 1st 2023 and modified for the last time November 1st 2022. Nevertheless, there are 169 other medical trials that currently require volunteers to join them in their pursuits of knowledge."
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