Impact of Lactobacillus crispatus-containing oral and vaginal probiotics on vaginal health: a randomised double-blind placebo controlled clinical trial.
- 2023-04-14
- Beneficial Microbes 14(2)
- R. Mändar
- G. Sõerunurk
- J. Štšepetova
- I. Smidt
- T. Rööp
- S. Kõljalg
- M. Saare
- K. Ausmees
- D. D. Le
- M. Jaagura
- S. Piiskop
- H. Tamm
- A. Salumets
- PubMed: 36856121
- DOI: 10.3920/BM2022.0091
Abstract
Health of reproductive tract is tightly associated with balance of microbial communities in this area. Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) represent common disturbances of vaginal communities. Vaginal discharge due to BV or VVC is a very frequent reason for visiting gynaecologist. We aimed to evaluate the impact of the novel evidence-based probiotics on BV and VVC patients. The study group included 89 BV and 93 VVC patients (aged 18-50 years) who were recruited into randomised double-blind placebo-controlled two-arm parallel trial. The patients of each diagnosis group received oral or vaginal probiotic capsules, or placebo capsules during 3 months. A probiotic capsule contained two (DSM32717 and DSM32720, in case of BV) or three (DSM32720, DSM32718 and DSM32716, in case of VVC) Lactobacillus crispatus strains. Vaginal, intestinal and general health was monitored weekly by questionnaire. Blood analyses were done in the beginning and at the end of trial. Vaginal samples were collected monthly, microscopic and molecular analyses were performed. The study revealed that both oral and vaginal capsules reduced the signs and symptoms in BV patients. Remarkable improvement was noted in Nugent score, amount and smell of discharge, but also in itching/irritation. Consumption of vaginal probiotics significantly increased the lactobacilli counts in their vagina while mean proportion of some BV-related bacteria decreased. In VVC patients, both oral and vaginal capsules lowered the combined score of two most important symptoms, amount of discharge and itching/irritation. In conclusion, the novel formulations of evidence-based well-focused probiotic L. crispatus strains are effective against BV and VVC being suitable for both vaginal and oral administration. Clinical trial registration: ISRCTN34840624, BioMed Central.
Keywords: Lactobacillus crispatus; bacterial vaginosis; probiotic; vaginal health; vulvovaginal candidiasis.
Research Insights
| Supplement | Health Outcome | Effect Type | Effect Size |
|---|---|---|---|
| Lactobacillus crispatus | Improved Vaginal Health | Beneficial | Large |
| Lactobacillus crispatus | Increased Vaginal Lactobacillus Counts | Beneficial | Moderate |
| Lactobacillus crispatus | Reduced Symptoms in VVC Patients | Beneficial | Moderate |
| Lactobacillus crispatus LBV 88 | Increased Vaginal Lactobacillus Counts | Beneficial | Moderate |
| Lactobacillus crispatus LBV88 | Improved Symptoms of Bacterial Vaginosis | Beneficial | Large |
| Lactobacillus crispatus LBV88 | Increased Vaginal Lactobacilli | Beneficial | Moderate |
| Lactobacillus crispatus LBV88 | Reduced Vaginal Candidiasis Symptoms | Beneficial | Moderate |
| Lactobacillus crispatus LCr86 | Increased Vaginal Lactobacillus Counts | Beneficial | Moderate |
| Lactobacillus crispatus LCr86 | Reduced Vaginal Candidiasis Symptoms | Beneficial | Moderate |
| Lactobacillus crispatus LV5 88 | Improved Symptoms of Bacterial Vaginosis | Beneficial | Large |
| Lactobacillus crispatus LV5 88 | Increased Vaginal Lactobacilli | Beneficial | Moderate |
| Lactobacillus crispatus LV5 88 | Reduced VVC Symptoms | Beneficial | Large |
| Lactobacillus crispatus UALcr-35 | Improved Symptoms of Bacterial Vaginosis | Beneficial | Large |
| Lactobacillus crispatus UALcr-35 | Increased Vaginal Lactobacillus Counts | Beneficial | Moderate |
| Lactobacillus crispatus UALcr-35 | Reduced VVC Symptoms | Beneficial | Large |
| Lactobacillus crispatus VPro 31 | Increased Vaginal Lactobacilli | Beneficial | Moderate |
| Lactobacillus crispatus VPro 31 | Reduced Vaginal Candidiasis Symptoms | Beneficial | Moderate |