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Infant Gut Microbiome Biomarker Study Underway

Sleeping infant in diaper

(Cheryl Holt, Pixabay.

8 Aug. 2022. A clinical study has begun analyzing infants’ stool samples to determine the characteristics of healthy microbial communities in young children. The research, called My Baby Biome, is conducted by Persephone Biosciences Inc. in San Diego, a developer of synthetic biological treatments for disorders of the microbiome, particularly diseases associated with the gut.

Persephone Biosciences is a five year-old company designing engineered biologics that address conditions in communities of bacteria and other microbes in the human microbiome. The microbiome is an emerging area for health researchers, with more recent discoveries pointing to links between conditions of microbes in the gut and disorders elsewhere in the body, including those not often associated with the gut.

Persephone Bio is currently conducting large-scale observational studies, with participants providing stool and other samples for analysis. The company says the studies are generating data connecting gut bacteria to genomic profiles and metabolic conditions from people who give permission to access their electronic health records. Those data, say the company, make it possible to associate microbial profiles in individuals to specific disorders. As reported by Science & Enterprise last month, one of those studies is investigating associations between the gut microbiome and advanced cases of four solid tumor cancers: non-small cell lung cancer, triple negative breast cancer, colorectal cancer, and pancreatic cancer.

Associate infant microbiome with childhood immune health

The company expects data from its observational studies to guide development of probiotics and synthetic live biologic therapies that work in the gut. Persephone Bio says biomarkers or molecular indicators revealed by the research provide targets for designing healthy engineered microbes that address precise disease conditions. In April, the company announced a collaboration with synthetic biology tools and materials company Ginkgo Bioworks to develop engineered biologic therapies from modified bacterial forms called bacteroids that live in the human gut in an anaerobic or oxygen-free environment.

The My Baby Biome clinical study aims to recruit 600 U.S. infants in a registry, to provide stool samples for analysis by the company. The research team says it enrolled its first participant, looking for indicators of dysbiosis, or imbalances in the composition of gut microbes in babies, from newborns to two months old. In addition, parents are asked to complete questionnaires on their children’s immune health.

Persephone Bio is looking primarily for biomarkers in the first six to 12 months from fecal genomics, transcriptomics, and proteins expressed, along with metabolic indicators associated with a healthy infant microbiome. The company also plans to track the children for seven years, noting microbial conditions associated with any immune disorders, such as allergies or skin disorders, reported in questionnaires sent to parents.

“This study,” says Persephone Bio co-founder and CEO Stephanie Culler in a statement released through BusinessWire, “the largest ever conducted to be focused on the infant microbiome, is a significant step in exploring the complex interactions between a child’s microbiome and immediate and eventual health outcomes, including immunology, allergy, overall health, and treatment response.”

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