# Cervical Cancer Prevention Prebiotic Device

> **NIH NIH R41** · GLYCIOME, LLC · 2021 · $399,993

## Abstract

A novel, intravaginal prebiotic-gel (“PreBioGyn”) is proposed for cervical cancer prevention, through optimization
of vaginal health and treatment of vaginal dysbiosis (pathogen and pathobiont overgrowth
), related to high-risk
human papillomavirus (hrHPV) persistence and oncogenesis. PreBioGyn is
an OTC user-directed, Class 2
medical device, uniquely innovative for women in Low Resource Settings (LRS), at greatest risk of death from
cervical cancer. Increased rates of hrHPV persistence and cervical cancer are directly and indirectly linked to
vaginal dysbiosis, due to elevations in vaginal pH levels, depletion of beneficial vaginal microbiota (e.g.
Lactobacillus crispatus), and disruption of the mucosal barrier. Cervicitis and reduced vaginal acidity are leading
risk factors for cervical cancer formation and progression. There is a significant need for an affordable, easy-to
use vaginal product that optimizes vaginal pH,
microbiota and mucosal function, to prevent cervical cancer
.
Existing vaginal pH “correcting” buffer-gels lower pH, but harm Lactobacillus
and mucosal cells and/or don’t
conform to WHO guidelines for vaginal safety. This is of critical public health significance
given that ~90% of
women report use of at least one vaginal product in any past 90 days, with use of such products increasing
urogenital events (e.g. vaginal dysbiosis) 3-fold. In fact, a significant overlap occurs between women with high
vaginal product use, hrHPV persistence and cervical cancer incidence, due, in part, to product-related vaginal
microbiome and mucosa damage. Preliminary data show that the PreBioGyn patent-pending gel, with a novel
prebiotic ingredient combination, supports L. crispatus while suppressing cervical cancer-linked P. bivia growth
and is unparalleled in mucosal safety. Glyciome and academic partners (Brigham &Women’s Hospital and Univ
of Puerto Rico School of Medicine) propose Phase 1 STTR studies to establish preclinical safety, efficacy and
feasibility of the prebiotic gel and novel applicator (low-waste and shipping cost, enhanced user-ease and
comfort). Successful completion of Phase 1 will demonstrate the following. 1) Vaginal biocompatibility of the gel
in a physiologically relevant human in-vitro model vs leading buffer-gels, based on quantitative measures of: no
cervicovaginal cell damage, inflammation and/or immunotoxicity; selective epithelial colonization by Lactobacilli;
and no enhanced proliferation of pathobionts or cervical cancer cells. 2) User perception and acceptability of gel
and applicator vs leading gels in quantifiable milestones of acceptance. 3) Physicochemical and functional
properties of the gel over time and vs leading gels to demonstrate stability, and superior functionality and
conformance with recommended guidelines. 4) Final design of an Integrated Manufacturing Prototype for
coordination with the proposed manufacturer. Successful completion of the project will lead to STTR Phase 2
manufacturing scale up, cli...

## Key facts

- **NIH application ID:** 10252708
- **Project number:** 1R41CA254543-01A1
- **Recipient organization:** GLYCIOME, LLC
- **Principal Investigator:** Joanna Elizabeth Ellington
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $399,993
- **Award type:** 1
- **Project period:** 2021-06-17 → 2023-06-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10252708

## Citation

> US National Institutes of Health, RePORTER application 10252708, Cervical Cancer Prevention Prebiotic Device (1R41CA254543-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10252708. Licensed CC0.

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