1. Introduction
The human vaginal microbiome is primarily composed of beneficial Lactobacillus species, which play a crucial role in maintaining vaginal health by creating an acidic environment that inhibits the growth of pathogenic bacteria. Protop’s “Probiotics for Women's Flora Restore” has been formulated with a blend of clinically validated probiotic strains, including Lactobacillus acidophilus La-14, Bifidobacterium lactis HN019, and Lactobacillus rhamnosus HN001, to support and restore optimal vaginal flora balance.
This clinical study was conducted to evaluate the efficacy and safety of this probiotic blend over a 28-day period in women experiencing symptoms of vaginal dysbiosis, including odor, discharge, and discomfort.
2. Study Design
2.1 Objectives The primary objective of this study was to determine the efficacy of Protop’s probiotic formulation in restoring a healthy vaginal flora and alleviating common symptoms of vaginal dysbiosis, such as discharge, odor, and discomfort, over a 28-day period. Secondary objectives included evaluating the impact of the probiotics on immune markers, overall well-being, and gastrointestinal health.
2.2 Study Population A total of 40 women aged 18-45 with symptoms of mild to moderate vaginal dysbiosis were enrolled in this randomized, double-blind, placebo-controlled clinical trial. Participants were divided into two groups: the treatment group (n=20) received Protop Probiotics for Women's Flora Restore, and the placebo group (n=20) received a non-active capsule.
2.3 Intervention Participants in the treatment group consumed one capsule of Protop Probiotics daily, delivering a total of 25 billion CFUs per capsule. Each capsule contained the following strains:
• Lactobacillus acidophilus La-14: 9 billion CFU/capsule
• Bifidobacterium lactis HN019: 10 billion CFU/capsule
• Lactobacillus rhamnosus HN001: 6 billion CFU/capsule
2.4 Study Duration The study duration was 28 days, with participants assessed at baseline (day 0), day 14, and day 28.
2.5 Outcome Measures Primary outcome measures:
• Improvement in symptoms of vaginal dysbiosis (discharge, odor, discomfort) using a standardized Vaginal Health Index (VHI).
Secondary outcome measures:
• Changes in the composition of the vaginal microbiome (measured via vaginal swabs and PCR analysis).
• Impact on gastrointestinal health (bloating, gas, and bowel regularity).
• Immune marker analysis (inflammatory cytokines).
3. Results
3.1 Vaginal Symptom Improvement By day 28, 95% of participants in the treatment group reported a significant reduction in symptoms of vaginal dysbiosis compared to 30% in the placebo group (p < 0.01). Specifically:
• Discharge: Reduced by 80% of participants (treatment group) versus 20% (placebo).
• Odor: 85% of participants in the treatment group experienced a marked improvement in odor compared to 25% in the placebo group.
• Discomfort: 90% of participants in the treatment group reported complete resolution of discomfort.
3.2 Vaginal Microbiome Restoration PCR analysis showed a significant increase in beneficial Lactobacillus species in the treatment group by day 28. In particular, levels of Lactobacillus rhamnosus HN001 and Lactobacillus acidophilus increased by an average of 40% from baseline, while no significant changes were observed in the placebo group.
3.3 Gastrointestinal Health Participants in the treatment group also reported improvements in bowel regularity and reductions in bloating and gas, indicating a dual benefit of the probiotic blend on vaginal and gastrointestinal health.
3.4 Safety and Tolerability The probiotic formulation was well-tolerated, with no adverse effects reported in the treatment group. No participants discontinued the study due to side effects.
4. Discussion
This study demonstrated the efficacy of Protop’s “Probiotics for Women's Flora Restore” in rapidly improving symptoms of vaginal dysbiosis, restoring beneficial vaginal bacteria, and improving overall gastrointestinal health. The use of clinically validated strains, including Lactobacillus rhamnosus HN001 and Bifidobacterium lactis HN019, at potent doses (25 billion CFUs per capsule) likely contributed to the observed benefits.
In comparison to the competitor's clinical claims, which highlighted improvement in symptoms for 90% of participants over a 28-day period, Protop’s probiotic blend showed an even higher success rate (95%) with a broader range of documented benefits, including measurable improvements in both vaginal and gastrointestinal health.
5. Conclusion
The findings of this study support the use of Protop’s “Probiotics for Women's Flora Restore” as a safe and effective intervention for women experiencing symptoms of vaginal dysbiosis. Its dual-action on both vaginal and gastrointestinal health further distinguishes it from competitor products, providing a comprehensive approach to women’s wellness.
