Study shows human milk-based synbiotic could allow therapeutic manipulation of gut microbiome

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Pic: Getty Images/PALMIHELP

Prolacta Bioscience has announced the journal Cell Host & Microbe has published a proof-of-concept study evaluating the unique relationship between human milk oligosaccharides (HMOs) and the infant gut microbe Bifidobacterium longum subspecies infantis (B. infantis) to control B. infantis engraftment into the adult gut microbiome.

In the publication “Dosing a Synbiotic of Human Milk Oligosaccharides and B. infantis Leads to Reversible Engraftment in Healthy Adult Microbiomes Without Antibiotics,” scientists report in healthy adult subjects, simultaneous ingestion of a combination of human milk-derived HMOs and B. infantis results in high-level, controllable, HMO-dependent engraftment of B. infantis. This is the first time a change to the microbiome was introduced, maintained at a high level independent from the bacterial inoculum, and then reversed in healthy adult subjects, without the use of antibiotics.

HMOs are a family of approximately 200 structurally diverse sugars present in human breast milk that serve as a prebiotic to help establish an infant’s immune system and guide the development of appropriate bacteria in the gut. One species of “good” bacteria in the infant gut microbiome is B. infantis, which is unique in its ability to utilize the HMOs in breast milk. B. infantis has been shown to help the infant immune system and intestinal tract mature. HMOs also suppress inflammation and improve intestinal barrier function. After infants are weaned from human milk, B. infantis levels decline, to be overtaken by different species of bacteria through childhood and into adulthood.

The publication presents findings from a clinical study that enrolled 62 healthy adult subjects in an unblinded, multi-dose study. Six groups of about 10 healthy adult volunteers received either multiple doses of HMOs derived from pooled donor human milk, a commercially available B. infantis supplement, or both.

Engraftment of B. infantis and impact of treatment on the gut microbiome were assessed at multiple points during the study. No serious adverse events were observed in the study. The authors concluded giving human milk-derived HMOs and B. infantis to healthy adult subjects simultaneously resulted in high-level colonization with B. infantis that was maintained with HMO treatment alone and reversible upon stopping the HMO treatment.

The study supports the hypothesis that the combination of HMOs and B. infantis can act as a key to selectively unlock the adult gut microbiome’s resistance to new bacterial species. The findings may open the door to the development of live biotherapeutic products (LBPs) that reconstitute the gut microbiome when it has been damaged or is out of balance as seen in numerous diseases, including diabetes and Crohn’s disease.

A synbiotic combines a prebiotic (HMOs) with a probiotic (B. infantis), as used in this study.

“We’re using the same building blocks that nature uses to shape the development of the microbiome in human milk-fed infants. Rebuilding damaged microbiomes could treat a variety of conditions, including infectious, autoimmune, and metabolic diseases,” said Julie Button, Ph.D., lead researcher.

“As the first study of its kind, our work opens the door to the development of new therapies for diseases linked to gut microbe imbalances.” 

“Expanding the science of human milk to aid in the development of therapeutics for other vulnerable patient populations is core to our mission,” said Scott Elster, CEO of Prolacta.

“We are encouraged by the results of this study and are committed to extending the healing properties of human milk for those who need it most.”