Your Health, Our Mission.

We deliver a safe, medically supervised approach.

We are committed to providing high-quality medically supervised fecal microbiota transplants (FMT) for autism and the diverse range of symptoms that come with being on the spectrum. We offer expert medical oversight, along with individualized treatment that delivers excellent and lasting results.

Our Treatment is Delivering Excellent Results

Novel Biome has developed and successfully executed a clinically proven treatment protocol which is improved over the pivotal protocol first developed by Dr. James Adam and his team at Arizona State University (ASU).

In this original ASU study, children were given 8 weeks of daily FMT treatment. 80% improvement over baseline in digestive related symptoms at 18 weeks was observed. Additionally, they observed a 25% improvement in autism-related symptoms score after only 18 weeks. In a two year follow up of patients in this study, they observed the 80% improvement in digestive symptoms maintained and a further 20% improvement in autism-related symptoms was reported, for a total of nearly 50% improvement from the baseline of the study.

We at Novel Biome have adjusted this protocol resulting in improved results compared to those observed in the ASU study. The protocol improvements are as follows: Individualized pre-FMT treatment plan / Extended treatment period (from 8-weeks of treatment to 16-weeks) / Optimized both the loading + maintenance dose in terms of the method of delivery (treatment approach).

Safety is our primary focus. The most critical component of your child’s medically supervised FMT treatment is adequate donor screening and high quality product manufacturing! Here at Novel Biome™, we make this our #1 priority and follow all FDA and American Gastroenterology Association donor screening standards to ensure the highest quality end product is used in our treatment. We have made significant investments into building a “state of the art” lab facility in North America and it is in this lab where we process and manufacture our FMT product.

3 Key Points

Confidence in our program safety

Our medically supervised treatment protocol uses safe and efficacious product derived from our best in class donor screening program.

Confidence in our program efficacy

Our FMT treatment protocol has demonstrated significant improvement over baseline in digestive related symptoms and improvement in autism-related symptoms score after treatment. Additionally we have observed further improvement over longer term follow-up.

Confidence in our focus on data collection and treatment outcomes measurement, transparency, communication and follow-up

We at Novel Biome™ are dedicated to data collection during and after treatment through clinical follow-up. We have a dedicated clinical data team in place to ensure we capture data that we can share to generate greater awareness and serve to expand our understanding of how and who FMT is most indicated for. We are focused on transparency throughout the entire journey to ensure you are making informed decisions that are in your or your child’s best interest.

Treatment Costs

The majority of treatment costs reflect our costs related to donor testing, lab process manufacturing, location rentals, and staffing contract costs. We are driven by data capture to help guide treatment and allow us to understand in which areas FMT has helped and in which areas there are more opportunities for improvement. As such, we include as part of the treatment protocol a CARS2 (Childhood Autism Rating Scale) assessment for each child, which is done pre and post-FMT. The CARS assessment is widely used and an empirically validated autism assessment. This assessment helps to identify where children are on the autism severity scale using quantifiable ratings based on direct observation by a certified professional. This assessment will be scheduled over Zoom.

Costs:

Total cost between product, medical consults and ongoing support is $14,300 USD

Important note:

The physician assistant treatment package isn’t to replace your doctor, who we are happy to engage and collaborate with, however, it’s an opportunity for us to apply our experience in treating ASD children with FMT to ideally prepare them for treatment. Working with our physician’s assistant (Marie), we will include 3 consults as part of a package.

Consult 1 (1 hr): Pre-FMT to look at labs and do a in-depth intake to guide the pre-treatment (will include applicable medication prescriptions)

Consult 2 (30 min): This consult will be in the first 4-5 weeks of starting FMT to troubleshoot and provide suggestions on diet, supplements, etc.

Consult 3 (30 min): This consult will be after completing FMT to review progress and discuss opportunities for continued support of the new transplanted microbiome

Between these consults, you will also have the opportunity to reach out to Marie to ask any questions you might have.

Optional Testing Costs:

Optional testing to help guide pre-treatment prescriptions/treatment that includes an understanding of the gut microbiome and mold exposure. We are happy to discuss these up front with you:

Lodging and transportation are organized as needed by families.

What To Expect

Once you arrive at the treatment clinic location:

A further 15 weeks of “at home” treatment will accompany you home with the appropriate storage supplies for the remainder of the treatment.

Follow up support with bi-weekly meetings to tailor dietary and lifestyle interventions.

Donor Screening

The most critical component of your child’s medically supervised FMT treatment is adequate donor screening! Here at Novel Biome™, we make this our #1 priority and follow all FDA and American Gastroenterology Association donor screening standards to ensure the highest quality product. All of our donors reside in North America.

The donors undergo routine screening for both blood and stool borne pathogens. Before becoming a donor, they undergo this rigorous screening and then again on a routine basis to ensure all collected and processed materials are safe to be implanted.

Serologic testing:

Stool testing:

In addition to extensive laboratory analysis, the donor’s medical background and health history is pivotal in determining whether or not they would make a suitable donor. All donors are vaginally born, breastfed, active, physically fit and have never received antibiotics in their lives. Additionally, they eat a diverse omnivorous diet to ensure as much bacterial diversity as possible.

A basic screen of their medical history would include the following diseases:

Take the Next Step

Book Your Treatment

Please contact us to discuss our treatment approach, to receive more information or to join one of our treatment retreats. 

We have treatment centres in Mexico, Hungary and Australia with more coming soon.

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