Effect of pHyph, A novel antibiotic-free treatment, on bacterial vaginosis symptoms and vaginal microbiome composition
4 affiliations
- 1Centre for Translational Microbiome Research, Department of Microbiology, Tumor and Cell Biology (MTC), Karolinska Institutet, Stockholm, Sweden
- 2Gedea Biotech AB, Medicon Village, Lund, Sweden
- 3Department of Medical Biochemistry and Microbiology, Science for Life Laboratory, Uppsala University, Uppsala, Sweden
- 4Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Skåne University Hospital, Lund University, Sweden
Abstract
Background: Bacterial vaginosis (BV) is the most prevalent vaginal infection among reproductive-age women and is associated with increased susceptibility to gynecological complications. Current antibiotic treatments achieve high initial cure rates but show high rates of recurrence, partly due to their inability to remove persistent biofilms. pHyph is a novel, non-antibiotic treatment that lowers vaginal pH, promoting Lactobacillus growth and biofilm disruption.
Objective: To evaluate the immediate and long-term effects of pHyph on the vaginal microbiome, BV resolution, and symptom reduction.
Study design: In a randomized, controlled, partially blinded study, 61 women with clinically diagnosed BV were randomized to immediate (IT, n = 35) or delayed (DT, n = 26) treatment. Vaginal swabs were collected before treatment, after 6 days, and during maintenance to Day 70. Microbiome composition was analyzed using a qPCR panel targeting 47 bacterial and 6 fungal species.
Results: Compared to controls, pHyph reduced the abundance of multiple BV-associated species and increased Lactobacillus iners following 6-day treatment (median 8.96 ×103 [Q1–Q3: 3.10 ×103–2.72 ×104] vs. median 9.44 × 10² [Q1–Q3: 0.00–4.29 × 10 ³] normalized qPCR counts, p < 0.05). Additionally, pHyph reduced BV-related symptoms, particularly fishy odor (p < 0.05). Treatment promoted a shift to CST III microbiome composition, and maintenance dosing was associated with sustained Lactobacillus abundance up to Day 70.
Conclusions: pHyph shows potential as an alternative BV treatment by reducing BV-associated pathogens while promoting lactobacilli. Extended dosing may enhance microbiome stability.
Related
- Large-scale metagenomic characterization of the vaginal microbiome and uropathogens in women with recent bacterial vaginosis and urinary tract infections
- Effectiveness of male partner treatment in reducing recurrence of bacterial vaginosis: a systematic review and meta-analysis
- Perturbation-based propagation of bacterial composition uncertainty improves robustness and reproducibility of microbiome differential abundance analysis.
- Exploratory pilot study of a spray-type probiotic delivery system for vaginal health in women at risk for bacterial vaginosis
- Bacterial profile and antibiotic susceptibility of bloodstream infections among infants, children, and adolescents undergoing treatment for acute leukemia
BibTeX
@article{lahtinen2026effect,
title = {{Effect of pHyph, A novel antibiotic-free treatment, on bacterial vaginosis symptoms and vaginal microbiome composition}},
author = {Emilia Lahtinen and Luisa W. Hugerth and Gabriella Edfeldt and Annette Säfholm and Sten Kornfält and Helena Strevens and Ina Schuppe-Koistinen},
journal = {European Journal of Obstetrics \& Gynecology and Reproductive Biology: X},
year = {2026},
month = oct,
doi = {10.1016/j.eurox.2026.100497},
url = {https://doi.org/10.1016/j.eurox.2026.100497},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Effect of pHyph, A novel antibiotic-free treatment, on bacterial vaginosis symptoms and vaginal microbiome composition
AU - Emilia Lahtinen
AU - Luisa W. Hugerth
AU - Gabriella Edfeldt
AU - Annette Säfholm
AU - Sten Kornfält
AU - Helena Strevens
AU - Ina Schuppe-Koistinen
PY - 2026
DA - 2026/10/08
JO - European Journal of Obstetrics & Gynecology and Reproductive Biology: X
DO - 10.1016/j.eurox.2026.100497
UR - https://doi.org/10.1016/j.eurox.2026.100497
AB - Background: Bacterial vaginosis (BV) is the most prevalent vaginal infection among reproductive-age women and is associated with increased susceptibility to gynecological complications. Current antibiotic treatments achieve high initial cure rates but show high rates of recurrence, partly due to their inability to remove persistent biofilms. pHyph is a novel, non-antibiotic treatment that lowers vaginal pH, promoting Lactobacillus growth and biofilm disruption. Objective: To evaluate the immediate and long-term effects of pHyph on the vaginal microbiome, BV resolution, and symptom reduction. Study design: In a randomized, controlled, partially blinded study, 61 women with clinically diagnosed BV were randomized to immediate (IT, n = 35) or delayed (DT, n = 26) treatment. Vaginal swabs were collected before treatment, after 6 days, and during maintenance to Day 70. Microbiome composition was analyzed using a qPCR panel targeting 47 bacterial and 6 fungal species. Results: Compared to controls, pHyph reduced the abundance of multiple BV-associated species and increased Lactobacillus iners following 6-day treatment (median 8.96 ×103 [Q1–Q3: 3.10 ×103–2.72 ×104] vs. median 9.44 × 10² [Q1–Q3: 0.00–4.29 × 10 ³] normalized qPCR counts, p < 0.05). Additionally, pHyph reduced BV-related symptoms, particularly fishy odor (p < 0.05). Treatment promoted a shift to CST III microbiome composition, and maintenance dosing was associated with sustained Lactobacillus abundance up to Day 70. Conclusions: pHyph shows potential as an alternative BV treatment by reducing BV-associated pathogens while promoting lactobacilli. Extended dosing may enhance microbiome stability.
SN - 2590-1613
ER -