FMT Clinical Trials in Autism

The incidence rate of diagnosed Autism (ASD) continues to rise as according to the US Centers for Disease Control and Prevention, now, about 1 in every 59 children in the U.S. is diagnosed with Autism (ASD), up from 1 in every 150 in the year 2000. Up until now, effective treatments for ASD have included speech and social therapy, psychiatric medications, behavioral therapy, and dietary and nutritional approaches. Currently, no medical treatments have been approved to treat core symptoms of ASD such as social communication difficulties and repetitive behaviors.

Today, there are many clinicians focused on the importance of the gut microbiome and its association with brain and neurological health. There is growing clinical interest in understanding the impact of changes to normal gut microbiota and how these changes may act as a trigger for many human diseases such as Clostridium difficile infection, conditions associated with Irritable Bowel Disease (IBD), and Autism (ASD). In Autism (ASD), clinical researchers have found that approximately 30 – 50% of children have chronic gastrointestinal (GI) problems, primarily constipation and/or diarrhea that can last for many years. This chronic discomfort and pain can cause irritability, decreased attention, learning difficulties, and negatively impact their behavior.

Fecal Microbiota Transplant (FMT) is a medical procedure being studied across many disease states that are the result of damaged gut flora or an unhealthy gut microbiome. Researchers have found factors like non-vaginal birth, diet and medical treatment with antibiotics can negatively impact our gut flora resulting in an unhealthy gut microbiome. The transplantation of a healthy gut microbiome through FMT revitalizes our body’s immune system and reverses the overgrowth of harmful bacteria. In this procedure, a healthy fecal sample from a healthy screened donor is transplanted into the patient to stimulate good bacterial growth in the gut. The patient receives their transplant through medically supervised administration of an enema or by taking capsules that contain a freeze-dried powder manufactured through a laboratory process resulting in a tasteless, odorless capsule delivery. These capsules are enteric-coated to ensure targeted delivery.

There is a great deal of promising clinical research focused on Autism (ASD) involving the manipulation of the gut microbiome through FMT:

In Australia, Fecal Microbiota Transplantation (FMT) was initially developed by Dr. Borody at his Centre for Digestive Diseases in Sydney. At the center, Dr. Borody oversaw more than 18,000 FMTs since 1987 for various diseases or disorders. He pioneered in Australia the use of FMT for colitis and Clostridium difficile infection and was the first to use oral FMT to treat children with ASD.  In his research, he found there to be dosing differences with treatment. He reported only one dose of FMT is usually enough to cure C. difficile infections, but his patients with Autism required much longer dosing schedules. He reported that 3 months of daily FMT was required to treat his Autism (ASD) patients. In terms of clinical outcomes, Dr. Borody saw significant improvements in both GI and autism symptoms.

This clinical success led to another clinically focused study conducted in 2017 at Arizona State University (ASU) titled, “Long-term benefit of Microbiota Transfer Therapy (or FMT) in Autism symptoms and gut microbiota“. Researchers, Adams, Krajmalnik-Brown, and Kang demonstrate long-term beneficial effects for children diagnosed with ASD through FMT. This study demonstrated remarkable improvements in gut health and autism symptom improvement at the study’s scheduled end.

The study demonstrated a 45% reduction in core ASD symptoms (language, social interaction, and behavior) at two years post-treatment compared with before treatment began. The ASU study compared differences in the microbiome of children with autism compared with typically developing children. At the start of the study, children with autism were found to have lower diversity in their respective gut microbes and were depleted of certain strains of helpful bacteria, such as Bifidobacteria and Prevotella. In terms of longer-term results reported in this study, 2 years after treatment, most of the initial improvements in gut symptoms remained and parents of the children in the study reported a continued reduction of ASD symptoms.

Another study entitled “Dynamics of Gut Microbiomes in Autism Spectrum Disorder (ASD) Symptoms” is being conducted at the Children’s Hospital of Los Angeles. The purpose of this study is to demonstrate the clinical benefits of (FMT) for children and young adults with Autism Spectrum Disorder (ASD) over 2 years. The study was started in August 2019 and it is set to complete in March 2022.

In Israel, an interventional clinical study entitled “FMT in Children with Autism and Gastrointestinal Symptoms” conducted at the Shamir Medical Center has randomized patients (n = 50) to receive FMT capsules. The focus of this study is to demonstrate that changing the gut microbiome could lead to improvement in both ASD and gastrointestinal (GI) symptoms. This study was started in February 2020 and the completion date is set for December 2022.

At Novel Biome, Dr. Jason Klop, ND and team are actively collecting treatment outcomes data related to FMT treatment for Autism (ASD). Data collection is focused on symptom outcomes measurement related to both gut health improvement and ASD-related symptoms and their plan is to measure outcomes out longitudinally for 2 years post-treatment.

In summary, there is growing clinical interest in understanding the important role of healthy gut microbiomes. There is also increasing clinical interest in demonstrating positive clinical benefit and treatment outcomes through FMT for children with Autism (ASD) who suffer chronic GI problems and debilitating symptoms associated with ASD. Completed studies have demonstrated significant improvements in both GI and Autism symptoms and more studies are currently underway.

Our focus at Novel Biome is in supporting autistic children who suffer from digestive symptoms and significant microbiome imbalance to restore their microbiome through FMT. You can learn more about our approach to treatment by going here.

In health,

 Team Novel Biome

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