As everybody knows, there is an exponential growth in autism cases. Despite the rapid increase in caseload, research in this field is minimal. Postmortem brain tissue studies revealed gross epigenetic errors, which gave the impression that it is challenging to develop a drug that can correct these errors; hence this diagnosis goes out of the radar of investors or the pharmaceutical industry. Few academicians are representing the research in this field. There are very few treatment modalities that are relevant for autism. In recent research, it was proved that faecal microbiota transfer therapy could help alleviate core symptoms of autism. However, some mice studies demonstrated the association between gut microbes and epigenetic errors in autism. In very few human studies, FMT had shown some promising results. The results of FMT in autism motivated us to work in this regard.
In our research exploring the role of gut microbes and autism, we have realized that most autistic kids could have been born neurotypical. We understood that environmental toxins disrupting man microbe symbiotic relationship during pregnancy resulting in autism; hence early detection of toxins like Bisphenol A and other pesticides in the blood of pregnant women and detoxing pregnant women could prevent autism. Like folic acid supplementation in antenatal programmes eradicated conditions like anencephaly and neural tube defects, adding N-acetyl cysteine, a glutathione precursor and dietary fibre, may prevent or eliminate autism. This possibility has motivated us to do this academic clinical trial.
Of the ~80,000 industrial chemicals registered with EPA for commercial use, only 5% (~4000) are characterized as toxic substances to the human body. However, on average, 2500 new chemicals are being introduced into the market each year, which are being used in more than 6 million products for human consumption, many of which resist human metabolism, thereby accumulating in the human body. These toxins damage the human body directly through their toxicity or indirectly by killing the friendly microbes in our gut, disrupting symbiotic relationships and promoting ill-health.
The environmental working group (EWG) and Rachel’s Network conducted a study on cord blood in 2007-2009. They found that 9 out of 10 cord blood samples from babies of African, American, Asian, and Hispanic descent have shown bisphenol A (chemical widely used in hardening plastics). Further, they identified 232 environmental toxins in human cord blood, which is evidence of fetuses developing in a toxic bath.
Researchers increasingly believe that these toxic substances disrupt our symbiotic relationship with our evolutionary friends, resulting in various diseases. Therefore, we have realized the importance of in-depth academic research to explore the robustness of symbiotic relationships with our gut microbes. We, therefore, have taken the initiative to investigate the causal association between environmental toxins and the gut microbiome (gut microbial ecosystem) and their role in autism.
Faecal microbiota transfer therapy is categorized under the drugs category for regulatory considerations. However, following the research process of drugs for a modality like faecal microbiota transfer therapy is an expensive affair with minimal or no return of investment; hence this research is not in the good interest of the pharmaceutical industry. USFDA categorised FMT as a drug that is closing the doors of FMT research which could be detrimental for the entire humankind. USFDA should reconsider revising their policies regarding FMT research as this may have more immense consequences compared to the little boy on Hiroshima
Humans evolved six million years ago. The thing that never happened in millions of years occurred in the last 40 years. Usage one element, lead resulted in the downfall of the roman empire, 80,000 chemicals dumped into the environment in previous 40 years could lead to human extinction and autism could be the significant path for human extinction, prediction of autism incidence in 2050 could be an eye-opener for the future. Hence autism and FMT research should be taken as a global responsibility.
We have taken an initiative of an academic clinical trial. We will be recruiting 100 children diagnosed with autism spectrum disorder, and these children will be treated with faecal microbiota transfer therapy. In addition, gut microbiome tests and epigenetic tests will be done before and after treatment to assess the changes in microbiome profiles and epigenetic signatures and are correlated with clinical outcomes, thereby establishing etiopathogenesis to propose treatment modality for autism and design antenatal program for effective prevention.
Though we may or may not be successful in getting approvals for treatment modality with this small academic trial, we will show the association between gut microbes and autism. In addition to this, we envision creating a digital platform where authentic scientific information regarding autism is made available for parents and professionals to enable them to choose the treatment modalities wisely.
Suppose the preliminary results of the trial are satisfactory. In that case, we envision establishing exclusive medical facilities that can guide and train parents to “DO-IT-YOURSELF” faecal microbiota transfer therapy under medical professional’s supervision and help them improve the quality of life of affected individuals.
Sponsor : Providence Microbiome Research Center Pvt Ltd.(Recognised by startup india)
CRO : KSBIO Clinserve (Dr Naresh MD)
Data Management : Inductive Quotient Analytics Pvt Ltd
Microbiome and Epigenetic testing support : National Genomics Core, center for DNA Finger Printing and Diagnostics. Agenes info Omics Pvt Ltd.
Site : St Theresa hospital, Hyderabad
Investigators : Dr Chandrashekhar Thodupunuri MBBS PGDCC MAPS Practitioner
Clinical Advisory Board:
Scientific Advisory board:
CTRI Registration number: CTRI/2022/02/040457
Contact us for participation: