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Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial.
BMC Womens Health. 2015 Dec 03; 15:115.BW

Abstract

BACKGROUND

This multicentre, randomised, double-blind, placebo-controlled trial was performed to determine whether the use of oral probiotic preparation (prOVag®) containing three Lactobacillus strains together with standard metronidazole treatment and also targeted antibiotic treatment (following the failure of metronidazole therapy) could reduce the recurrence rates of bacterial vaginosis (BV) and aerobic vaginitis (AV).

METHODS

Patients at private gynaecological clinics in Poland with histories of recurrent BV/AV and current symptoms were randomly allocated to receive metronidazole and probiotic or placebo, and assessed monthly on visits II and III-V. The total number of study visits was 5-6 (I, II, II bis - if applicable, III, IV, V). One probiotic or placebo capsule was administered with metronidazole/targeted antibiotic twice daily for 10 days; during follow up, patients took one capsule daily for 10 days perimenstrually. Clinical examination and vaginal swabbing were performed at each visit. Primary outcomes were clinical or microbiological BV/AV recurrence and probiotic safety. Secondary outcomes were vaginal pH, Nugent score, and Lactobacillus counts in the vaginal microbiota. Safety analysis was performed in 578 (probiotic, n = 285; placebo, n = 293) 18-50-year-old women who were randomised.

RESULTS

BV/AV was confirmed microbiologically in 241 (probiotic, n = 118; placebo, n = 123) participants, who continued the trial. Data from 154 (probiotic, n = 73; placebo, n = 81) participants who completed the study were analysed to determine the efficacy of prOVag. Additional analyses included 37 (probiotic, n = 22; placebo, n = 15) participants who received targeted antibiotics and probiotics or placebo. prOVag lengthened the time to clinical relapse of BV/AV symptoms up to 51 % (p < 0.05) compared with placebo; AV relapse was delayed by up to 76 % (p < 0.05). Probiotic use also reduced and maintained low vaginal pH and Nugent score, and increased vaginal Lactobacillus counts following standard treatment.

CONCLUSION

This study demonstrated that oral probiotics lengthened remission in patients with recurrent BV/AV and improved clinical and microbiological parameters.

TRIAL REGISTRATION

NCT01993524 ; 20 November 2013.

Authors+Show Affiliations

Chair of Microbiology, Jagiellonian University Medical College, Krakow, Poland. piotr.heczko@pebeha.pl.Chair of Microbiology, Jagiellonian University Medical College, Krakow, Poland. a.tomusiak@uj.edu.pl.Institute of Nature Conservation, Polish Academy of Sciences, Krakow, Poland. adamski@iop.krakow.pl.Clinical Department of Obstetrics and Gynecology, Central Clinical Hospital of Ministry of Interior and Administration, Warsaw, Poland. jakimiuk@yahoo.com. Department of Reproductive Health Research Institute of Mother and Child, Warsaw, Poland. jakimiuk@yahoo.com.IBSS BIOMED S.A, Krakow, Poland. grzegorz.stefanski@biomed.pl.IBSS BIOMED S.A, Krakow, Poland. aleksandra.cichonska@biomed.pl.IBSS BIOMED S.A, Krakow, Poland. magdalena.suda@biomed.pl.Chair of Microbiology, Jagiellonian University Medical College, Krakow, Poland. mbstrus@cyf-kr.edu.pl.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26635090

Citation

Heczko, Piotr B., et al. "Supplementation of Standard Antibiotic Therapy With Oral Probiotics for Bacterial Vaginosis and Aerobic Vaginitis: a Randomised, Double-blind, Placebo-controlled Trial." BMC Women's Health, vol. 15, 2015, p. 115.
Heczko PB, Tomusiak A, Adamski P, et al. Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial. BMC Womens Health. 2015;15:115.
Heczko, P. B., Tomusiak, A., Adamski, P., Jakimiuk, A. J., Stefański, G., Mikołajczyk-Cichońska, A., Suda-Szczurek, M., & Strus, M. (2015). Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial. BMC Women's Health, 15, 115. https://doi.org/10.1186/s12905-015-0246-6
Heczko PB, et al. Supplementation of Standard Antibiotic Therapy With Oral Probiotics for Bacterial Vaginosis and Aerobic Vaginitis: a Randomised, Double-blind, Placebo-controlled Trial. BMC Womens Health. 2015 Dec 3;15:115. PubMed PMID: 26635090.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial. AU - Heczko,Piotr B, AU - Tomusiak,Anna, AU - Adamski,Paweł, AU - Jakimiuk,Artur J, AU - Stefański,Grzegorz, AU - Mikołajczyk-Cichońska,Aleksandra, AU - Suda-Szczurek,Magdalena, AU - Strus,Magdalena, Y1 - 2015/12/03/ PY - 2014/06/16/received PY - 2015/10/06/accepted PY - 2015/12/5/entrez PY - 2015/12/5/pubmed PY - 2016/7/9/medline SP - 115 EP - 115 JF - BMC women's health JO - BMC Womens Health VL - 15 N2 - BACKGROUND: This multicentre, randomised, double-blind, placebo-controlled trial was performed to determine whether the use of oral probiotic preparation (prOVag®) containing three Lactobacillus strains together with standard metronidazole treatment and also targeted antibiotic treatment (following the failure of metronidazole therapy) could reduce the recurrence rates of bacterial vaginosis (BV) and aerobic vaginitis (AV). METHODS: Patients at private gynaecological clinics in Poland with histories of recurrent BV/AV and current symptoms were randomly allocated to receive metronidazole and probiotic or placebo, and assessed monthly on visits II and III-V. The total number of study visits was 5-6 (I, II, II bis - if applicable, III, IV, V). One probiotic or placebo capsule was administered with metronidazole/targeted antibiotic twice daily for 10 days; during follow up, patients took one capsule daily for 10 days perimenstrually. Clinical examination and vaginal swabbing were performed at each visit. Primary outcomes were clinical or microbiological BV/AV recurrence and probiotic safety. Secondary outcomes were vaginal pH, Nugent score, and Lactobacillus counts in the vaginal microbiota. Safety analysis was performed in 578 (probiotic, n = 285; placebo, n = 293) 18-50-year-old women who were randomised. RESULTS: BV/AV was confirmed microbiologically in 241 (probiotic, n = 118; placebo, n = 123) participants, who continued the trial. Data from 154 (probiotic, n = 73; placebo, n = 81) participants who completed the study were analysed to determine the efficacy of prOVag. Additional analyses included 37 (probiotic, n = 22; placebo, n = 15) participants who received targeted antibiotics and probiotics or placebo. prOVag lengthened the time to clinical relapse of BV/AV symptoms up to 51 % (p < 0.05) compared with placebo; AV relapse was delayed by up to 76 % (p < 0.05). Probiotic use also reduced and maintained low vaginal pH and Nugent score, and increased vaginal Lactobacillus counts following standard treatment. CONCLUSION: This study demonstrated that oral probiotics lengthened remission in patients with recurrent BV/AV and improved clinical and microbiological parameters. TRIAL REGISTRATION: NCT01993524 ; 20 November 2013. SN - 1472-6874 UR - https://www.unboundmedicine.com/medline/citation/26635090/Supplementation_of_standard_antibiotic_therapy_with_oral_probiotics_for_bacterial_vaginosis_and_aerobic_vaginitis:_a_randomised_double_blind_placebo_controlled_trial_ L2 - https://bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-015-0246-6 DB - PRIME DP - Unbound Medicine ER -