Your Health, Our Mission.

We deliver a safe and 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 focused on improving symptoms associated with GI dysfunction and autism, with the goal of improving quality of life.

Our Treatment Protocol is Grounded in Science and Delivers Results

Novel Biome™ has developed and successfully executed a clinically proven treatment protocol which is an improvement on the pivotal protocol first developed by Dr. James Adam and his team at Arizona State University (ASU)¹.

In this original ASU study, children were given 8 weeks of daily FMT treatment. Over the 18-week treatment protocol, gastrointestinal (GI) symptoms showed an average improvement of 82% over baseline¹. Additionally, they observed a 24% improvement in autism-related symptoms scores after only 18 weeks¹. In a two-year follow-up of patients in this study, they observed that improvements in GI symptoms were maintained, and the severity of ASD symptoms was also improved². Specifically, autism-related symptoms showed a further 23% improvement, for a total of nearly 50% improvement from baseline².

We at Novel Biome™ have adjusted this protocol resulting in improved results compared to those observed in the ASU study¹. Ourprotocol improvements include:

An individualized pre-FMT treatment plan
Extended treatment period (from 8-weeks of treatment to 16-weeks)
Optimization of both the loading and maintenance FMT doses in terms of the method of delivery and concentration of bacteria per dose

Safety is our primary focus, and we understand that 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 by applying our extensive donor screening criteria to ensure the highest quality end product is used in our treatment. We have made significant investments in our manufacturing process, creating a pharmaceutical-grade lab facility in North America to best ensure the highest quality product we can.

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 ASD 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 who ensure we capture data, using validated tools, which we can share to generate greater awareness and serve to expand our understanding of FMT and whom it 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. To best ensure safety and quality, we utilize a state-of-the-art laboratory for manufacturing and perform extensive donor screening and blood and stool testing. In addition, 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 part of the treatment protocol, a Childhood Autism Rating Scale (CARS2) assessment is done pre-and post-FMT for every child. The CARS assessment is widely used and an empirically validated autism assessment¹. This assessment helps to identify where children are on the autism severity scale using quantifiable ratings based on direct observation by a certified professional.

Costs:

FMT product for 16 weeks of treatment is $12,500 USD
3 medical consults with physician assistant is $750 USD
MD Consult at treatment centre to initiate and oversee treatment is $250 USD
CARS2 assessment pre and post-FMT (total time commitment is approximately 1-2 hours per assessment) with a total cost of $800 USD (not required for non-ASD patients)

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

The total time commitment at the treatment location is 5 days, with two of the five days including medically supervised FMT treatment
15 weeks of at-home FMT materials, for a total of 16-weeks, will be supplied to you for ongoing treatment
Guidance on your specific pre-FMT treatment to optimize your child’s gut and overall health so they better respond to the treatment. Nearly always includes antimicrobial or antibiotic treatment with applicable prescriptions made by our physician’s assistant Marie Mvogo.

Once you arrive at the treatment clinic location:

Day 1 Arrive at treatment location airport + transport to suggested hotel
Day 2 Medical Consult and Bowel Cleanse
Day 3 First FMT treatment utilizing enema or capsules for the “loading dose”
Day 4 Second FMT loading dose treatment
Day 5 Transport back to the airport for the trip home. Maintenance treatment to start when you arrive back home.

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

Donor Screening is our #1 Priority

At Novel Biome™, we understand that the most critical safety component of your child’s medically supervised FMT treatment is appropriate and safe donor screening! This is why we make this our #1 priority, ensuring that we manufacture the highest quality product we can in our pharmaceutical-grade lab facility. Our manufacturing process includes extensive donor screening along with appropriate medical assessment and blood and stool testing.

Donor Screening:

We use stringent initial screening criteria exceeding all published screening standards^4-13. In addition to extensive laboratory analysis, the donor’s medical background and health history are pivotal in determining whether or not they would make a suitable donor.

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

Chronic infectious disease(s)
Known exposure to HIV or Viral Hepatitis
Autoimmune disease(s)
Gastrointestinal disease or symptoms
Atopic disease(s)
Metabolic disorders
Mood disorders and Neuro-Atypical
Neurodegenerative Disorder(s)
Chronic pain syndrome
Malignancies
Obesity

We ensure high-quality donors by surpassing screening standards^4-13 and only select donors who are vaginally born, breastfed, active, physically fit, no history of neurological, psychiatric or neurodevelopmental disorders, eat a diverse omnivorous diet and have never received antibiotics in their lives, all factors that are known to affect the microbiome^14-16.

Novel Biome’s initial donor screening goes above and beyond the standard^4-13

Standard initial medical and health screening^4-13	Novel Biome’s initial screening
-	Vaginally born
-	Breastfed
Donor ages range from ≥18 and ≤60 years old	All donors under 30 years of age
General healthy diet	Confirmed diverse omnivorous diet
<3 months use of antibiotics, antifungals, antivirals, immune-suppressants, chemotherapy	No lifetime use of antibiotics, antifungals, antivirals, immune-suppressants, chemotherapy
-	Never smoked and lives in a non-smoking home (both tobacco and cannabis)
Only recent allergic reactions	No allergies
No travel of 6 months to tropical countries and high-risk areas of communicable disease/ infectious intestinal diseases	No travel for 12 months outside of home country
Inquire about 13 different infectious diseases	Inquire about 34 different infectious diseases
-	No treatment or diagnosis for ADHD and ADD
-	No sleep issues (e.g. insomnia, frequent waking, nightmares)

Blood and Stool Testing:

Once a donor has passed our initial screening, we then apply another set of stringent screening, to rule out any possible abnormalities that may be found in blood or stool. . All our donors reside in North America and undergo both initial and routine (every 90 days) screening that includes 120 testing parameters to evaluate blood and stool, including parasites, viruses, fungi, and active infections to ensure all collected and processed materials are safe to be implanted. To best ensure quality and safety, all stool that is processed and manufactured is first held in quarantine for 90 days to ensure all blood and stool screening passes our standards. For additional safety, we keep a portion of all manufactured samples to ensure in the case of an adverse event, we are able to perform additional testing.

Complete Blood Count (CBC) & Comprehensive Metabolic Panel (CMP)
HIV, type 1 and 2
Hepatitis A virus IgM
Hepatitis B surface antigen
Hepatitis C virus antibody
Treponema pallidum (Cascade with reflex to RPR)
Total of 54 blood tests

Stool testing:

C difficile toxin B by PCR
Routine bacterial culture for enteric pathogens
Ova and parasites
PCR stool testing for beneficial fecal flora, pathogenic organisms, including bacteria, fungi, and parasites
Multidrug-Resistant Organisms (MDROs): ESBL, MRSA, VRE
Total of 73 stool tests

1. Kang et al., 2017, 2. Kang et al., 2019, 3. Moulton et al., 2019, 4. Cammarota et al., 2017, 5. Jørgensen et al., 2017, 6. Australian Regulatory Guidelines of Biologicals., 2020, 7. Cammarota et al., 2019, 8. Mullish et al., 2018, 9. Terveer et al., 2017, 10. Bakken et al., 2011, 11. Kelly et al., 2015, 12. Woodworth et al., 2017, 13. Sokol et al., 2016, 14. Gomaa et al., 2020, 15. Shao et al., 2019, 16. Pannaraj et al., 2017

Take the Next Step

Book Your Discovery Call

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, Panama, Hungary and Australia with more coming soon.