Digestive System Disorders
Alcohol-associated liver disease
Dr. Jasmohan Bajaj at the Virginia Commonwealth University leads an NIH-funded placebo-controlled trial studying the effects of Microbiota Transplant Therapy on alcohol cravings. This work builds on promising prior observations in recipients of fecal microbiota transplants.
Hepatic Encephalopathy
Dr. Jasmohan Bajaj has recently published results of the THEMATIC clinical trial showing benefit of Microbiota Transplant Therapy in patients with advanced liver disease at risk for hepatic encephalopathy and already taking maximal medical therapy with lactulose and rifaximin. We are starting to work on a multi-center clinical trial within the VA system to follow-up on this work.
Crohn’s Disease
Dr. Byron Vaughn and Dr. Alexander Khoruts are leading a multi-center clinical trial of Microbiota Transplant Therapy in Crohn’s disease. The trial is partially funded by The Leona M. and Harry B. Helmsley Charitable Trust. Patients are being recruited at the University of Minnesota, Harvard Medical School, Indiana University, Mount Sinai Hospital in New York, Cornell University, and Henry Ford Health in Michigan.
Diet optimization after FMT in patients with C. difficile infections
Drs. Levi Teigen and Alexander Khoruts are studying how to optimize dietary management of patients being treated for recurrent C. difficile infections with fecal microbiota transplantation.
Primary Sclerosing Cholangitis
Drs. Elizabeth Aby, Alexander Khoruts, and John Lake are conducting a pharmacokinetic study of Microbiota Transplant Therapy in PSC. The trial uses a prolonged antibiotic conditioning regimen with vancomycin and ampicillin given prior evidence that vancomycin alone has potential benefit in PSC.
Clostridioides difficile Infections
The American Gastroenterological Association is keeping a National Registry of clinical outcomes in patients with C. difficile infections being treated with fecal microbiota transplantation. The data are entered by clinical providers across the country. The work is partially funded by NIH.
Neurodevelopmental Disorders
Autism and Pitt-Hopkins Syndrome
Drs. James Adams and Rosa Krajmalnik-Brown at the Arizona State University lead clinical trials studying Microbiota Transplant Therapies in autism and Pitt-Hopkins Syndrome. These conditions are associated with increased levels of microbial metabolites in the gut, which are detrimental to gut and brain functions. Our studies show that restructuring the gut microbiome using MTT leads to decreased levels of detrimental microbial metabolites and improved symptoms. A start-up company Gut-Brain-Axis Therapeutics is working to build on this work to commercialize MTT and make the treatment available to many more patients.
Neurodegenerative Disorders
Amyotrophic Lateral Sclerosis (ALS)
Dr. Richard Bedlack at Duke University is starting to explore Microbiota Transplant Therapy in ALS.
Immune System Modulation
Food Allergies
Dr. Rima Rachid at the Boston Children’s Hospital is leading the clinical trials investigating Microbiota Transplant Therapies in food (peanut) allergies. The gut microbiome calibrates immune responses in the body and preliminary evidence suggests potential for benefit of MTT in allergic and autoimmune disorders.
Cardiovascular Disorders
Pulmonary Arterial Hypertension
Dr. Thenappan Thenappan at the University of Minnesota is conducting clinical trials using Microbiota Transplant Therapies in pulmonary arterial hypertension.
Congestive Heart Failure
Drs. Ryan Demmer, Melana Yuzefpolskaya, and Paolo Colombo at the Mayo Clinic and Columbia University are starting clinical trials using Microbiota Transplant Therapy in congestive heart failure.
Infectious Diseases
Antibiotic Resistance
Dr. Michael Woodworth at Emory University is using fecal microbiota transplantation to tackle the growing problem of antibiotic resistance. The study is partially funded by the Centers for Disease Control.
Optimization of Cancer Therapies
Complications of bone marrow transplantation
Dr. Armin Rashidi at the Fred Hutchinson Cancer Center in Washington leads clinical trials using Microbiota Transplant Therapy to mitigate complications of bone marrow transplantation, including graft-versus-host disease and infections. The study is partially funded by the Lymphoma and Leukemia Society.
Optimization of checkpoint immunotherapy in lung cancer
Investigators at the University of Minnesota are completing a phase II, double blind, placebo controlled clinical trial in which patients receive either Microbiota Transplant Therapy or placebo alongside immunotherapy for non-small cell lung cancer.