ACT supports multidisciplinary, collaborative academic research focused on restoring the microbiome with one goal in mind...cures! Our research projects and collaborations are rapidly expanding and spread across multiple health conditions. Read more about our academic collaborators and current research projects below.
Placebo controlled trials are studying the impact of microbial restoration in patients with end stage liver disease and cirrhosis who can experience confusion due to high ammonia and inflammation connected to changes in the gut microbiome. Additional information on this clinical trial is available here. Read more about the impact of microbial composition in liver disease and cirrhosis here.
A placebo-controlled trial at the University of Minnesota investigating the role of bacteria linked to hydrogen sulfide gas and inflammation in Ulcerative Colitis. Visit their site to learn more about the study. Hear more from the principal investigator, Dr. Byron Vaughn and in their published journal article.
This phase 1 single blinded, placebo-controlled trial is currently recruiting patients. More trial information and eligibility criteria are available here.
A larger, multi-site trial is also emerging. Please check back for additional details, including recruitment and eligibility criteria.
This placebo-controlled trial has reached recruitment goals and should have results available by the end of the year. Hear more about the impact of microbial restoration on Graft Versus Host Disease and non-cancer related mortality after bone marrow transplantation from Dr. Shernan Holtan at the University of Minnesota here and from Dr. Armin Rashidi here.
This phase 2 clinical trial is investigating the efficacy of Fecal Microbiota Transplant in treating recurrent C. difficile infections. More information on the clinical trial is available here.
A phase 2 double blind, double placebo-controlled clinical trial studying the impact of Fecal Microbiota Transplant in treating recurrent C. difficile Infections in solid organ transplant recipients. Trial details are available here.
Clinicians and providers in this collaborative trial are actively treating patients with recurrent C. difficile infections through Intestinal Microbiota Transplants and maintaining a single registry evaluating clinical results.
This phase 1, open label study has begun recruitment. More information is available here. Read more from the investigators in their publication (link to abstract only, access available upon request to the investigators or a journal subscription).
Details on this Phase II, double blind, placebo controlled trial are available here.
A Phase 2, double-blind, placebo-controlled study is underway at Arizona State University utilizing Microbiota Transplant Therapy with pediatric and adult patients. More information regarding the current trial is available here.
Click below to view information on previous trials.
A pilot clinical trial designed to investigate the safety of Fecal Microbiota Transplants in patients with Diverticulitis. This study is currently recruiting patients. Clinical trial and recruitment details are available here.
Clinical trial details are available here. This study is not yet recruiting participants.
This pilot clinical trial is currently recruiting patients. More trial information and eligibility criteria are available here.
Hidradenitis Suppurativa (HS) is a chronic inflammatory skin condition resulting in painful skin abscesses and scarring. A study at the University of Minnesota is investigating the impact of altering HS patients microbiome composition through microbiota transplant. Learn more about the clinical trial here.
Read more about the study premise in this emerging trial here.
A Phase 1, open label trial demonstrated the safety of Fecal Microbiota Transplants in peanut allergic patients. 30% of patients increased their amount of peanut protein they consumed without reaction.
A secondary trial was completed, including an antibiotic treatment prior to the administration of FMT. In this trial, 60% patients improved their peanut protein reactivity after one FMT.
Future trials are in planning to evaluate the efficacy of prolonged administration of FMT.
Investigators are researching the impact of Microbiota Transfer Therapy on Autism and gastrointestinal symptoms in patients with Autism. A phase 1 clinical trial found Autism symptoms reduced nearly 50% two years after microbiota therapy. Read more about the initial trial.
Additional information about the Autism Research Program at Arizona State University is available here.
ASU Researchers Dr. James Adams& Dr. Rosa Krajmalnik-Brown share results from their research.
Hear from patients enrolled in the trial and here.
Dr. Adams and Dr. Krajmalnik-Brown led a Phase 2, double-blind, placebo-controlled trial assessing the impact of Microbiota Transfer Therapy in patients with Pitt-Hopkins Disease, a genetic disease associated with a severe form of Autism. The study demonstrated microbiota transfer therapy is safe in Pitt-Hopkins patients with improvements in gastrointestinal and Pitt-Hopkins symptoms. The FDA is currently reviewing the treatment protocol for approval. Another trial is in development with a next-generation microbiota therapeutic to allow more patients access who are unable to swallow the standard microbiota therapeutic capsules.
A randomized, double-blind, placebo controlled trial investigating the impact of microbial restoration on patients being treated with intensive chemotherapy for acute leukemia. Study details are available here. Initial findings indicate Microbiota Transplant Therapy is safe in this patient population. A phase 2, randomized, double-blind trial found the patients receiving the active MTT therapy had a lower rate of infection than the placebo group.
Researchers are preparing for a third clinical trial to investigate whether FMT after an allogenic stem cell transplant, when compared to placebo, can prevent Acute-Versus-Host disease.
Investigators studied the connection between high levels of Hydrogen sulfide, sulfate reducing bacteria and inflammation in Ulcerative Colitis patients. The study suggests that "the increasing severity of inflammation in Ulcerative Colitis is due to the dilution of beneficial factors, concentration of toxic factors and changing detoxification capacity of the host, all of which are intimately linked to the nutrient flow from the diet." Read the full literature review here.
Researchers investigated the impact of altering the microbial composition on metabolizing sugar in pre-diabetic patients. Participants received an Intestinal Microbiota Transplant from screened, lean donors. Additional clinical trial information is available here.