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Biohm to Begin Study to Potentially Find Link Between Gut Microbiome and Autism


NEW YORK (GenomeWeb) – After launching a microbiome analysis kit for consumers last year, probiotics startup Biohm is now embarking on a new microbiological venture: a genomic study to determine if there is a link between autism and the human gut microbiome.

Biohm CEO and Founder Afif Ghannoum explained that his company saw potential in researching the disease after a number of customers for its Biohm Gut Report consumer genomics product began purchasing the test for their children with autism. Noticing that the samples had a curious imbalance, the company performed initial research and saw that the microbiome had a significant correlation with autism.

"When we saw there was a lack of information, we decided to leverage our technology and make it as accessible to as many people with autism or children with autism as possible," Ghannoum said.

The Cleveland, Ohio-based firm wants to collect data on the microbiomes of 25,000 individuals who have been diagnosed with autism. To do this, it will send study participants one of its home testing kits, which is used to collect a fecal sample. After filling out an informed consent form, families with autistic children mail the sample kit to the microbiome lab at Case Western Reserve University. As part of an ongoing agreement with Biohm to sequence human gut reports, researchers at the CWRU lab will extract DNA and analyze the samples using Thermo Fisher Scientific Ion Torrent sequencing technology and PCR testing to find profile the levels of different bacteria and fungi in the subject's intestinal flora.   

"[Since] the DNA sequencing is very expensive, we like to run the test with 96 samples per turn, which is why our [human gut report] take four to six weeks," explained Mahmoud Ghannoum, cofounder and CSO of Biohm, director of the center for medical mycology at CWRU, and Afif's father.   

"For bacterial detection, we use 16S sequencing, or a segment in the bacteria that is used to differentiate different species," Mahmoud explained. "We apply [internal transcribed spacer] sequencing for fungi, which highlights a region that shows differentiation between organisms."

Biohm will also compare the autistic children's microbiome data to a standard gut microbiome, in hope of identifying peculiar levels of bacteria and fungi that diverge from those in a normal microbiome.

Biohm believes a link might exist between the research subjects' microbiomes and a variety of potential issues, such as medications or cohorts of organisms that are elevated in people with autism. The company said it will provide all resulting data to researchers in the field for free. The data will be kept on a password-protected platform, where potential researchers will be able to examine it without access to personal information beyond the subject's age and location.

Families will also receive data on the levels of different bacteria and fungi that live in their autistic child's intestinal flora. For example, Biohm's current test records levels of pathogenic fungi within the Ascomycota phylum, which contain species of Candida that cause thrush and yeast infections.

It is unclear what participating families should do with that information, although Biohm has promised not to use the data for product sales. As part of its social mission, the firm wants to leverage its product to further scientific research and learn more about the widespread neurological condition. 

While the microbiome kits cost $180 for normal consumers, Biohm promises to give away 100 kits to study participants and will offer $80 to $100 off the remaining kits as part of the study. With each kit costing the firm $80 to sequence and analyze, Biohm plans to donate remaining profits to a list of autism research foundations selected by the study's participants.

Outside of the autism study, Biohm will continue to market its Biohm Gut Report, which has not been evaluated by the US Food and Drug Administration, to consumers. Aware that not many companies are performing "full-spectrum sequencing, [Biohm] decided to look at both bacteria and fungal populations in the individual's microbiome," Afif explained.

Customers can pay for a microbiome kit and send their sample to the lab at CWRU. Biohm then analyzes the data and sends the results to the consumer in four to five weeks. The report contains a handbook that gives the consumers a detailed glossary of species that potentially live in their microbiome. The report also provides the levels of microorganisms found in the samples, as well as a comparison to normal levels of bacteria and fungi found in the majority of human microbiomes. Because the human microbiome is filled with a vast array of microbial species, Biohm focuses on species that are shared in at least 20 percent of the human population.

The results include nutritional and wellness recommendations by nutritionists who work with Mahmoud Ghannoum's lab to "build out massive correlative data that can help people optimize their digestive and biomedical health." The company declined to comment on how many kits it has sold since its launch or how much data it has compiled in this regard.

According to Afif, Biohm's nutritionists might find an elevated type of bacteria or fungi, spiked by molecules like carbohydrates. Paying attention to the consumers' diets, the nutritionists may recommend the individual to lower their fast food intake, while increasing other types of foods.

Afif argues that finding levels of certain organisms might indicate the gut's microbial balance is off-kilter and that it needs probiotics to rebalance the ecosystem. As such, the company also offers a combination of probiotics called PathoBiome 30B that it claims will help breaks down digestive plaque and rebalance the gut's total microbiome.

"[The advice] is dietary specific, since diets and genetics are two of the largest factors in microbiome balance," Afif said. "While we can't affect genetics, we can make recommendations and optimize a person's diet to improve their microbiome."

While the standard gut reports include nutritional guidance, Afif said that the autism study participants will not receive such guidance because Biohm does not have enough data to make justified conclusions about their microbiomes.  

Daniel McDonald, director the American Gut Project, a non-profit research project run by the Rob Knight lab at the University of California, San Diego, however, warns consumers about using unregulated probiotics.

"Buying a bunch of probiotics is akin to going into the grocery store and buying a number of random drugs, consuming them, and hoping for some type of health benefit," he explained. "Consumers may want to be very careful of the use of pre- and probiotics, as in general they're not well understood."

To be fair, McDonald said that clinical data regarding a probiotic called VSL#3 suggests that it is effective in treating specific cases of patients with irritable bowel syndrome. In general, he stressed the importance of patients consulting with their medical professional if they choose to have a dietary change, such as ingesting probiotics based on nutritional advice from microbiome companies, for supposed health benefits.

In terms of a link to autism, McDonald also believes that a connection may exist between the disease and the human gut microbiome.There are numerous published reports about increased gastrointestinal distress with individuals on the spectrum, many of which are captured in a 2014 meta-analysis published in the journal Pediatrics. McDonald's team at the American Gut Project began a subproject in 2016 to collect fecal samples from patients with autism and any neurotypical siblings they might have. The team has so far collected a few hundred samples, but has not yet begun to analyze the data.

"I believe that we will eventually find that some level of genetic predisposition, combined with an environmental factor, such as the gut microbiome, is what contributes to [autism]," McDonald added.