Dr. Jasmohan Bajaj at the Richmond VA Medical Center and Virginia Commonwealth University completed placebo controlled trials studying the impact of microbial restoration in patients with End Stage Liver Disease, Cirrhosis and Hepatic Encephalopathy, where patients experience confusion due to high ammonia and inflammation connected to changes in the gut microbiome. 

Details on the most recent phase2, double blind, placebo controlled clinical trial are available here. In this trial, researchers found patients who received Fecal Microbiota Transplant had lower recurrences of Hepatic Encephalopathy than patients who received placebo. All patients also received current standard of care treatments Lactulose, to reduce ammonia in the bloodstream, and Rifaximin, an intestinal, non-absorbent, antibacterial agent. Published results of the clinical trial are available here.

Read more about the impact of microbial composition in liver disease and cirrhosis here and 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.

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A larger, multi-site trial is also emerging. Please check back for additional details, including recruitment and eligibility criteria.

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.

Investigators at the University of Minnesota are completing a phase II, double blind, placebo controlled clinical trial in which patients receive either microbiota therapy or placebo alongside immunotherapy for non-small cell lung cancer. The clinical trial is underway with additional details 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.

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Click below to view information on previous trials.

Diverticulitis patients develop inflamed pouches in their colon which can lead to painful complications. A pilot clinical trial at the University of Massachusetts is designed to investigate the safety of Fecal Microbiota Transplants in patients with Diverticulitis and inform the direction of future clinical trials. This study is currently recruiting patients. Clinical trial and recruitment details are available here.

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The World Health Organization predicts antibiotic resistance to be the leading cause of death, surpassing cancer, by 2050. Researchers at Emory University are investigating the safety and effectiveness of microbiota transplant therapy against multi-drug resistant organisms.

Clinical trial details are available here.  

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Primary Sclerosing Cholangitis is a devastating disease in which inflammation and scarring in the bile ducts lead to liver damage. The average life expectancy after diagnosis of PSC is 10-20 years. Researchers at the University of Minnesota are completing a pilot trial with microbiota transplants to test safety in this population and direct the development of future studies. This trial is currently recruiting patients. More trial information and eligibility criteria are available here.

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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.

A Phase 1, randomized, placebo-controlled clinical trial at Intermountain Health Park City Hospital is investigating the impact of microbiota therapy on kidney stone development. Additional clinical trial details are available 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 phase 1, open label clinical 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. Additional information about this trial is available here.

A new, phase 2, randomized, double-blind, placebo-controlled clinical trial is underway to investigate the impact of higher dosing of microbiota transplant therapy in patients with peanut allergies. In this trial, patients will receive a pre-antibiotic followed by 27 days of microbiota transplant therapy capsules or placebo capsules. Read more about the clinical trial here.

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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.

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Dr. Adams and Dr. Krajmalnik-Brown at Arizona State University 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.

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This phase 1 placebo-controlled trial demonstrated microbiota transplants are safe within this immunocompromised patient population. A follow up trial is underway to optimize dosing. Hear more about the impact of microbial restoration on Graft Versus Host Disease and non-cancer related mortality after bone marrow transplantation from Dr. Armin Rashidi here. You can also listed to updates from previous research studies with Dr. Shernan Holtan at the University of Minnesota here and from Dr. Armin Rashidi here.

Researchers at the University of Minnesota completed a phase 1, open label study testing the safety of microbiota transplants in patients with Pulmonary Arterial Hypertension. More information about the clinical trial 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).  Investigators are planning a follow up study.

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• In this trial, researchers monitored stool samples of patients successfully treated with Intestinal Microbiota Transplant capsules for recurrent C. difficile infections over a period of a year. All patients recovered clinically and none had exposure to antibiotics after transplant during the trial period.
• The majority of patients' microbiota resembled that of the donor throughout the entire period. However, in a quarter of patients the microbiota became entirely different from the donor at one year. In a minority of patients we did not see much in the way of donor microbiota at all.
• Read the full cited research publication here.

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 tracked the microbial communities of patients undergoing intensive chemotherapy for Acute leukemia and monitored the impact on the diversity of the gut microbiome. Investigators followed two groups of patients, those completing their first induction of chemotherapy and those undergoing repeat therapy.

The study found "larger departures of microbial communities from the pre-chemotherapy baseline during repeat therapy compared to first induction."

Read the trial publication here.

• Researchers studied the impact of diet on intestinal Sulfate Reducing Bacteria. This pilot crossover study monitored the gut bacteria of four healthy individuals, who followed two interventional diets for 10-14 days, containing high or low sulfur-containing amino acids (SAA). No major changes occurred in the quantity of Sulfate Reducing Bacteria, suggesting that "dietary interventions alone may be insufficient for rapid therapeutic targeting of Sulfate Reducing Bacteria." Read the trial publication here.

Researchers studied biomarkers of patients prior to Hematopoietic Cell Transplantation (HCT). Compared to 16 healthy control patients, "pre-transplant patients came to transplant with abnormal levels of all three biomarkers, reflecting residual damage from prior chemotherapy." The study suggests that pre-HCT interventions to the gut microbiome may decrease patient risk for Graft-Versus-Host disease post HCT. Read the study publication here.

Hear more about Graft versus Host disease from Dr. Shernan Holtan, researcher at the University of Minnesota.

This trial is an observational study monitoring the length of microbial disruption after chemotherapy and rounds of antibiotics for cancer treatment. Researchers found that microbial communities were "stressed beyond its ability to recover", even after antibiotics treatments ended.

You can read the trials research publication here and the clinical trial details 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.