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Fecal Microbiota Transplantation Capsule for Gastrointestinal Tract Graft Versus Host Disease (GvHD)
Study Summary
This trial is studying the side effects of using an investigational procedure, fecal microbiota transplantation, in treating patients with severe acute gut graft-versus-host-disease.
- Severe Gastrointestinal Tract Acute Graft Versus Host Disease (GvHD)
- Graft-versus-Host Disease
- Gastrointestinal Tract Graft Versus Host Disease
Timeline
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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- You can easily and safely swallow capsules without any difficulty or discomfort.You have a blockage in your intestines or a condition called toxic megacolon.You have a history of severe food allergies.You have a condition called delayed gastric emptying syndrome, which means your stomach takes longer than usual to empty its contents.You have allergies to certain ingredients found in the study medication, such as sodium chloride, glycerol, or gelatin.You are currently taking experimental medications for the treatment of gut GvHD.You have experienced symptoms of GvHD (graft-versus-host disease) within the first 100 days after a stem cell transplant.You are currently experiencing bleeding in your stomach or intestines.You have a condition where you frequently inhale food or liquid into your lungs.You have a history of inflammatory bowel disease like Crohn's disease or ulcerative colitis.Your blood pressure or heart rate is not stable.You have trouble swallowing because of problems with your throat or muscles, such as from a stroke or conditions like multiple sclerosis or ALS.You have stage 4 and experience frequent loose stools, severe stomach pain, bleeding, or blockage in your intestines.
- Group 1: Treatment (OpenBiome FMT capsule DE)
- 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
Am I qualified to participate in this research endeavor?
"This clinical trial seeks 10 participants between adolescence and late adulthood that have graft versus host disease. To qualify, one must be refractory to steroid treatment or resistant after 5 days of systemic steroids (> 1 mg/kg/day methylprednisolone), capable of swallowing capsules without difficulty, and in stage 4 with greater than 2 liters of stool per day as well as intense abdominal pain, haemorrhage or ileus."
Is there an opportunity for participants to join this research project?
"This clinical trial is no longer actively enrolling. It was first made available on September 1st 2023 and the information present was last altered more than a year ago, on September 16th 2022. Despite this study's closure, there are presently 171 other medical studies that need participants to be recruited."
Does this clinical experiment extend to patients of an underage age?
"Potential patients must be aged between 18 and 80 to take part in this study. Alternatively, there are 65 trials for those under the age of majority and 147 studies available to persons above seniority."
Has the Fecal Microbiota Transplantation Capsule received authorization from federal regulators?
"As this clinical trial is in its initial phase, Fecal Microbiota Transplantation Capsule has only limited research backing up its safety and efficacy. As such, we have assigned a score of 1 to it."
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