Effect of Probiotics Supplementation on Bacterial Vaginosis in pregnant women

Phase 3

Recruiting

Conditions: Pregnant woman in their third trimester with Bacterial vaginosis

Registration Number: CTRI/2013/01/003337

Lead Sponsor: INDIAN COUNCIL OF MEDICAL RESEARCH

Brief Summary: The incidence of female urogenital tract infection around the world is more than 300 million cases per annum. Bacterial Vaginosis (BV) represents the most common vaginal syndrome afflicting premenopausal and pregnant women, with an incidence rate ranging from 10% to 50%. BV is complex, polymicrobial disorder characterized by an overgrowth of strict or facultative anaerobic bacteria (*Gardnerella vaginalis, Prevotella, Mobiluncus, Mycoplasma horminis*) and a reduction of lactobacilli particularly those producing hydrogen perioxide. BV is frequently underestimated since the symptoms are often insignificant, however, the clinical consequences could be important. Cure rate of Bacterial Vaginosis with oral or local administration of metronidazole or intravaginal Clindamycin, ranges from 48-85%, however, 40% of women relapse within 3 months after initiation of antibiotic therapy and up to 50% of women after 6 months. The high recurrence rates with repeated exposure to antibiotics, results in the emergence of drug resistant strains. Since reduction of lactobacilli and increase in pH are the main pathogenesis of BV, probiotics have been suggested as a tool to treat and prevent BV. So this study has been designed to evaluate the efficacy and safety of probiotic Supplementation (*Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14* Strains) in Indian Adult Pregnant Women with Bacterial Vaginosis.

In order to fulfil the objectives of the study 400 women in 28th week of gestation will be screened for BV based Nugentâ€™s criteria. Then if they are meeting the mentioned inclusion and exclusion criteria then they will be recruited into the study after the written consent. Of the 400 pregnant women, 100 women who are positive for BV will be randomized to50 in each group to receive either probiotics (*Lactobacillus rhamnosus GR-1, L.reuteri RC-1*4) capsule or placebo capsule will be supplemented during third trimester till delivery. All women with BV will be treated with local antibiotic (Clindamycin) for a period of 5-7 days. The recruited subjects will be followed for 6 months that is 3 months (last trimester of pregnancy) during pregnancy and 3 months after delivery. Bacterial Vaginosis and Vaginal flora will be assessed at baseline and at 34, 38 weeks of gestation and 3 months after delivery to ensure persistence of supplemented strains and non-recurrence of BV. After delivery neonate stool and breast milk samples will be collected from 5th to 10th day of birth, and again at 3rd month. The outcome of the study will be cure rate of BV in women with and without probiotics and rate of recurrence of BV with probiotics.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 100

Inclusion Criteria

1.Pregnant woman in their third trimester with BV 2.Age 18 years and above 3.Signed Informed Consent.

Exclusion Criteria

Participation in any other clinical study during the study period/ 30 days before beginning of the present study 2.
HIV infected 3.
Multiple gestation 4.
Cervical incompetence (circlage in current gestation) 5.
Fetus with major congenital malformations in current gestation 6.
Insulin dependent diabetes mellitus, 7.
Systemic arterial hypertension under medication, 8.
Chronic asthma requiring intermittent therapy 9.
Continuous or recent corticosteroid therapy ( or any other medical or surgical complications in present gestation) 10.
Women aged less than 18 11.
Women who had intercourse in the last 24 hours will be excluded 12.
Known or suspected hypersensitivity to any of the ingredients of the trial medication 13.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rate of BV in women with and without probiotics	Assesed for BV cure by 38th week of gestation

Secondary Outcome Measures

Name	Time	Method
Rate of recurrence of BV with probiotics	3 month post partum

Trial Locations

Locations (1): Clinical and microbiology division NIN
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Clinical and microbiology division NIN
🇮🇳Hyderabad, ANDHRA PRADESH, India
DR R HEMALATHA
Principal investigator
040-27197297
rhemalathanin@yahoo.com