Supplementation of Standard Antibiotic Therapy With Oral Probiotics for Bacterial Vaginosis

NCT01993524 | Completed

• 1 other identifier: PB-DM/SBK-prOVag2-01/08
• Study Type: interventional
• Target: 594
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to determine whether supplementation of standard antibiotic therapy with oral probiotic preparation prOVag containing lactic acid bacteria influences recurrence of bacterial vaginosis/vaginitis.

Conditions

Bacterial Vaginosis; Bacterial Vaginitis

Outcome Measures

Primary Outcomes (1)

• Reduced probability of recurrent bacterial vaginosis/vaginitis.

  Recurrence of bacterial vaginosis/vaginitis at the third-fifth visits was considered to be the study endpoint (participant's withdrawal). The reduced probability of recurrent bacterial vaginal infection, confirmed by clinical and/or microbiological symptoms, was the parameter used to assess primary efficacy.

  assesed on visits III-V (assesed monthly within three months)

Secondary Outcomes (4)

• Change in vaginal pH level.

  assesed monthly within five-six months

• Change in Nugent score level.

  assesed monthly within five-six months

• Change in total Lactobacillus counts a in cultures from vaginal swabs.

  assesed monthly within five-six months

• The time to bacterial vaginosis/vaginitis recurrence

  assesed on visits III-V (assesed monthly within three months)

Study Arms (2)

probiotic

EXPERIMENTAL

At I visit standard treatment(500mg oral metronidazole twice daily for 7 days) and probiotic twice daily for 10 days. At II visit, participants were checked for signs of vaginal infection; if they were still present they were given a targeted antibiotic according to the microbiological analysis. Antibiotic was taken together with probiotic twice daily for 10 days. Participants showing positive response to metronidazole treatment on the II visit were given only the probiotic once daily for 10 days in the peri-menstrual period for the next 3 months. Participants with targeted antibiotic were to come to the visit IIbis, and if treatment was successful they were to proceed for the next 3 months in the same manner as those successfully treated with metronidazole, as described above.

Dietary Supplement: probiotic

placebo

PLACEBO COMPARATOR

At I visit standard treatment (500mg oral metronidazole twice daily for 7 days) and placebo twice daily for 10 days. At the II visit, participants were checked for signs of vaginal infection; if they were present they were given a targeted antibiotic according to the microbiological analysis. Antibiotic was taken together with placebo twice daily for 10 days. Participants showing positive responses to metronidazole on the II visit were given only placebo once daily for 10 days in the peri-menstrual period for the next 3 months. Participants with targeted antibiotic were to come to the visit IIbis, and if treatment was successful they were to proceed for the next 3 months in the same manner as those successfully treated with metronidazole, as described above.

Other: placebo

Interventions

probiotic DIETARY_SUPPLEMENT

antibiotic plus probiotic

probiotic

placebo OTHER

antibiotic plus placebo

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed Consent Form
• Subjects aged more than or equal 18 and less than or equal 50 years
• Women of the Caucasian race
• Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea) shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days)
• No irregularities identified in gynaecological examination (no pathology of reproductive organs, such as myomas, ovarian cysts)
• Susceptibility to recurrent vaginitis and/or urinary tract infections, as well as bacterial vaginitis confirmed at visit I

You may not qualify if:

• Subjects aged less than 18 and more than 50 years
• Hypersensitivity to any ingredient of the investigational product, metronidazole or antibiotic(s).
• Bleeding from genital tract of unknown aetiology
• Pregnancy
• Breastfeeding
• Congenital and acquired immunodeficiencies
• Diabetes
• Mental illness
• Neoplastic disease
• Application of mechanical contraceptives, such as: diaphragms, intrauterine contraceptive insert (except for Mirena intrauterine device)
• Application of NuvaRing hormonal contraceptive vaginal ring
• Application of hormonal preparations, such as: Vagifem, Ovestin and vaginal estrogens in reproductive period
• Application of another oral and/or vaginal probiotic at Subject qualification to the Study
• Participation in another clinical study / less than thirty-day interval from the last clinical study
• Mycotic vaginitis

Sponsors & Collaborators

• IBSS Biomed S.A.: lead

Related Publications (1)

• Heczko PB, Tomusiak A, Adamski P, Jakimiuk AJ, Stefanski G, Mikolajczyk-Cichonska A, Suda-Szczurek M, Strus M. 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. doi: 10.1186/s12905-015-0246-6.

  PMID: 26635090 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Zbigniew Chelmicki, MD, PhD

  "Polis CLINIC" Prywatna Opieka Lekarska Specjalistyczna Sp. z o.o, ul. 1-go Maja 88, 40-240 Katowice, Poland

  PRINCIPAL INVESTIGATOR

• Aleksandra M Cichonska, PhD

  IBSS Biomed S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 25, 2013
• Study Start: March 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 25, 2013

Record last verified: 2013-11