Effect of pHyph, a Novel Antibiotic-Free Treatment, on Bacterial Vaginosis Symptoms and Vaginal Microbiome Composition

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. p Hyph 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 p Hyph 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 , p Hyph reduced the abundance of multiple BV-associated species and increased Lactobacillus iners following 6-day treatment (median 8.96×10 3 [Q1–Q3: 3.10×10 3 –2.72×10 4] vs. median 9.44 × 10² [Q1–Q3: 0.00–4.29 × 10³] normalized qPCR counts, p < 0.05). Additionally, p Hyph 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 p Hyph shows potential as an alternative BV treatment by reducing BV-associated pathogens while promoting lactobacilli. Extended dosing may enhance microbiome stability.