Onegevity has been awarded an SBIR grant from the National Institutes of Health (NIH) to develop a multi-omics platform to study polycystic ovary syndrome in 2021. Thorne is assisting Onegevity to find participants who would be interested in volunteering for a clinical trial that will examine the nuances of PCOS in women who have been diagnosed and women who have not. To our knowledge, this is the first study of its kind aimed at building a comprehensive portfolio of data from every angle geared directly at women's health.

Thorne is excited to share this clinical trial opportunity with our community, and we are proud that Onegevity is taking a deep scientific look into a health concern that will benefit many of our customers.

PCOS is the most common endocrine disorder in women of reproductive age – seen in upward of 13 percent of women. So if you live with it, you are not alone. Due to PCOS's complex nature and unclear origin, it can take years to diagnose. Even after diagnosis, treatment and self-management options are minimal and don't work for everyone. With recent scientific technology developments in high-throughput next-generation sequencing, and molecular technologies, Onegevity has a unique opportunity to implement a multi-omic approach (genome, microbiome, metabolome, epigenome) to study women who have PCOS. The goal is to improve the diagnosis process, improve monitoring, and design personalized and efficacious therapy options. 

Who is eligible?

The PCOS study will enroll women, ages 18-40, who have been diagnosed with PCOS or not and who are NOT using hormones or hormonal birth control for the previous three months. Women should be otherwise healthy with no other significant medical or endocrine disorders. 

This study can only accept women living in the United States, but cannot enroll women who live in Rhode Island, New York, New Jersey, Maryland, North Dakota, South Dakota, or Hawaii. 

What to expect

If you are eligible and agree to participate, then after signing consent and filling out a questionnaire about some lifestyle habits, you will be sent a box of tests. Each woman will be asked to provide samples for comprehensive "omic" testing. From the privacy of her home, a woman will collect a stool sample that will be used to analyze her gut microbiome, use a vaginal swab that will be used to analyze her vaginal microbiome, and use a cheek swab that will be used for genetic testing. These samples are easy to collect and will include instructions and a pre-paid return packaging mailer.

You will also be required to visit a local diagnostics laboratory for a fasting blood draw for a thorough analysis of sex hormones (DHEA-s, estradiol, FSH, LH, progesterone, SHBG, testosterone, and TSH), a lipid panel (cholesterol, HDL, LDL, triglycerides), markers of insulin resistance (glucose, insulin, hemoglobinA1c), markers of stress (cortisol, hs-CRP), and vitamin D.

All testing will be paid for by the study. This study's expected time commitment is about two hours, and participants will receive all test results (valued at $800) and a $50 Amazon gift card upon completion. 

Data privacy 

Privacy of data and personal information is of utmost importance and will be treated as confidential information. Each participant's data will be coded and de-identified after collection and stored in locked files on servers behind firewalls. Personal information will not be disclosed unless required by law. A participant can drop out at any time with no questions asked.

The brief science

A multi-omic study is essential in characterizing PCOS because this syndrome has overlapping symptoms, multiple etiological factors, and complex physiology that involves numerous pathways, proteins, and systems. Gleaning from existing gut microbiome research, it is known that PCOS patients have lower gut microbiome diversity than non-PCOS women. Studies have found specific phylum associated with reproductive issues in PCOS, and some women show alteration in gut barrier function and endotoxemia or the presence of lipopolysaccharides (LPS) in their bloodstreams.

The gut microbiome can be a cause of insulin resistance, a classic symptom in women with PCOS. It can also play a role in other symptoms: hyperandrogenism, chronic inflammation, and metabolic syndrome. This is mainly a result of the gut microbiome's capability to influence energy absorption, the pathways of short-chain fatty acids (SCFAs), LPS, choline and bile acids, intestinal permeability, and the gut-brain axis. These metrics will be reported in the test these women complete for this study. Characterizing the gut microbiome of women with PCOS and optimizing their gut bacteria levels is an area of interest to Onegveity. 

Regarding the vaginal microbiome, women with PCOS tend to be more diverse than healthy women controls. A few specific bacteria are found in different amounts in healthy women, such as Lactobacillus crispatus, Mycoplasma, Prevotella, Escherichia coli (E. coli), and Streptococcus. Similarly, vaginal pH, blood levels of estradiol, LH, and FSH can significantly affect the distribution of the vaginal microbiome, validating the multi-omic approach to this syndrome. 

Although PCOS has a genetic component, much is still unknown about the underlying genetic component, which is why doing a genetic test in this study is important. Many genes have been associated with PCOS, affecting fertility directly and indirectly. Studies using family members with PCOS have failed to find a fully penetrant variant(s), but we are getting closer by the day.

To date, no one study has undertaken a complete study at the same time of these aspects of women's health, and Thorne hopes this study will help health-care practitioners understand PCOS from a holistic view. Onegevity intends to use artificial intelligence and the Onegevity Health Intelligence platform to bring these solutions to the public in the future in the form of the best lifestyle considerations, nutrition recommendations, and will work with Thorne to design and manufacture personalized supplement options.

If you are interested and eligible, please contact the study coordinator at StudyCoordinator@onegevity.com to learn more. The study has been approved by the University of Maryland Institutional Review Board (HP-00089723).

References

  1. Khan M, Ullah A, Basit S. Genetic basis of polycystic ovary syndrome (PCOS): Current perspectives. Appl Clin Genet 2019;12:249-260.
  2. Lindheim L, Bashir M, Münzker J, et al. Alterations in gut microbiome composition and barrier function are associated with reproductive and metabolic defects in women with polycystic ovary syndrome (PCOS): A pilot study. PLoS One 2017;12(1):e0168390.
  3. Zhao X, Jiang Y, Xi H, et al. Exploration of the relationship between gut microbiota and polycystic ovary syndrome (PCOS): a review. Geburtshilfe Frauenheilkd 2020;80(2):161-171.
  4. Hong X, Qin P, Huang K, et al. Association between polycystic ovary syndrome and the vaginal microbiome: A case-control study. Clin Endocrinol 2020;93(1):52-60.
  5. Xu J, Bian G, Zheng M, et al. Fertility factors affect the vaginal microbiome in women of reproductive age. Am J Reprod Immunol 2020;83(4):e13220.