Postbiotic Akkermansia Supports Metabolic, Endocrine, Microbiome Benefits in Women with PMOS: Study

AKK Probio, a postbiotic Akkermansia muciniphila ingredient distributed in the U.S. by Maypro, was shown to support beneficial changes in metabolic, endocrine, and gut microbiome biomarkers in a population of women with polyendocrine metabolic ovarian syndrome (PMOS), formerly known as polycystic ovary syndrome (PCOS). The findings were published in Clinical Nutrition.

The 12-week randomized controlled trial found that adjunctive supplementation with postbiotic Akkermansia muciniphila, when combined with standardized oral contraceptive therapy, was associated with improvements across multiple metabolic, endocrine, reproductive and gut microbiome measures compared with placebo plus standardized therapy.

PMOS affects approximately one in eight women worldwide. The condition was renamed in 2026 following a major international consensus effort designed to more accurately reflect its multisystem nature. Rather than focusing primarily on the ovaries and the misleading concept of ovarian “cysts,” the new name recognizes the interconnected endocrine, metabolic, and ovarian dysfunction that characterizes the condition.

This broader understanding of PMOS also makes the new AKK PROBIO research particularly timely, Maypro reported, as the study simultaneously evaluated metabolic health, reproductive endocrine function, clinical manifestations, and the gut microbiome.

The randomized controlled trial included 100 women with obesity-associated PMOS who were receiving standardized oral contraceptive therapy. Participants were randomized to receive either postbiotic AKK PROBIO at 10 billion cells equivalent per day or placebo for 12 weeks. Ninety-two women completed the intervention, including 47 in the AKK PROBIO group and 45 in the placebo group. An additional 30 healthy women served as a reference group.

Researchers conducted a broad assessment that included anthropometric measures, glucose-insulin homeostasis, lipid metabolism, sex hormones and reproductive endocrine measures, clinical manifestations of hyperandrogenism, menstrual regularity, gut microbiota and safety.

Over 12 weeks, participants receiving postbiotic AKK PROBIO showed improvements in several metabolic and reproductive endocrine measures compared with placebo, including:

• Significant reductions in fasting insulin and HOMA-IR, a widely used measure of insulin resistance
• A significant reduction in LDL cholesterol
• Significant reductions in serum testosterone and luteinizing hormone
• Improvement in the luteinizing hormone-to-follicle-stimulating hormone ratio
• Improvements in acne and hirsutism, common clinical manifestations associated with hyperandrogenism
• A substantial increase in the proportion of participants reporting regular menstrual cycles

What makes this study particularly interesting is the breadth of the response,” said Lauren Clardy, senior director of scientific affairs at Maypro. “We saw changes across insulin resistance, reproductive hormones and menstrual regularity, along with meaningful shifts in the gut microbiome. That is especially relevant now that PMOS is being recognized for what it is: a very complex condition involving interconnected metabolic, endocrine and reproductive pathways.”

Analysis of the gut microbiome showed that postbiotic AKK PROBIO supplementation was associated with significant changes in microbial diversity and overall community composition.

Researchers reported increases in potentially beneficial microorganisms, including Bifidobacterium and Faecalibacterium, along with reductions in Bacteroides, Ruminococcus and Fusobacterium, among other taxa of interest. The overall microbial profile also shifted in the direction of that observed in the healthy reference group.

“The findings add to a growing body of research examining the relationship between the intestinal microbiome and women’s metabolic and endocrine health,” said Xin Ma, R&D director of Thankcome Biological Science and Technology, the producer of AKK Probio. “The study found changes not only in specific microbial populations, but also across metabolic, endocrine and reproductive measures. These results provide an important foundation for continued investigation of the gut microbiome in PMOS.”

Postbiotic AKK PROBIO was well tolerated during the 12-week intervention. Liver and kidney function remained stable and within normal ranges, no gastrointestinal adverse events were reported, and researchers observed no apparent systemic safety concerns.

The study provides new clinical evidence supporting investigation of Akkermansia muciniphila in PMOS and expands the research surrounding AKK Probio beyond its established focus on metabolic and gut health.

“PMOS is an important example of why women’s health can’t always be approached one symptom or one pathway at a time,” Clardy said. “Metabolic health, insulin sensitivity, reproductive hormones and the gut microbiome are interconnected. This study gives us an important new window into how microbiome-focused interventions may fit into a more integrated approach to women’s health.”

AKK PROBIO is a proprietary strain of human intestinal-origin Akkermansia muciniphila developed by Thankcome and available in live probiotic and inactivated postbiotic forms. The postbiotic form retains membrane-associated and secreted bioactive components, including Amuc_1100 and P9, while offering the formulation stability required for applications such as functional foods, beverages, gummies, powders, and fast-melt products.

The new PMOS findings add to an expanding clinical research program investigating AKK PROBIO across metabolic health, gut barrier function, mood, sleep, liver health, sarcopenia, and healthy aging, Maypro reported.

In a previously published placebo-controlled, eight-week clinical trial involving 130 adults with overweight, live and postbiotic AKK PROBIO were evaluated for effects on body composition, metabolic measures and appetite-regulating hormones, including GLP-1, leptin and peptide YY. The research also examined measures related to mood, sleep quality and liver health.

AKK PROBIO recently completed the U.S. Food and Drug Administration’s New Dietary Ingredient (NDI) Notification process. According to Thankcome, it is the first gut-derived Akkermansia muciniphila strain of human intestinal origin to reach this regulatory milestone.

“AKK PROBIO is supported by two human clinical studies, 12 preclinical studies, and two safety assessments, with five additional human clinical trials underway. The ingredient is also backed by 19 granted patents. The strain has been deposited with four internationally recognized microbial culture collections across the United States, Germany, China, and Australia: ATCC (ATCC PTA-128002), DSM (DSM 35753), CGMCC (CGMCC 20955), and NMI (NMI V26-004872), respectively.” Clardy added. “Maypro is a distributor of AKK PROBIO in the United States. For product briefs, clinical research, formulation guidance, or samples, visit the contact page on Maypro.com.