A clinical trial to study the effectiveness of probiotics in lower reproductive tract infections in women.

Recruiting

• Conditions: Women with complaints of abnormal vaginal discharge suggestive of bacterial vaginosis

• Registration Number: CTRI/2013/05/003658
• Lead Sponsor: Dr Rukshana Shamshu

Brief Summary

In the SAT gynaecology OPD, 40 to 50% women present with vaginal discharge .24.7% of them have a flora suggestive of bacterial vaginosis.Incidence of HIV and STD are on an increase.

Bacterial Vaginosis has been found to be associated with preterm labour, PROM, postpartum endometritis, puerperal and post abortion sepsis which can be prevented by early treatment. it is also associated with post operative infectios ad vaginal cuff cellulitis.

To avoid the rising rates of antibiotic resistance, following use in lower reproductive tract infection the role of probiotics has been considered as a means of protection against lower reproductive tract infection.

Studies have proven the efficacy of probiotics in lower reproductive tract infectio in women.

Hence the significance of this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-20
• Last Update Posted: 2013-05-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

Women between 18 and 45 years attending gynaecology OPD with complaint vaginal discharge and/or vaginal itching who gives informed consent.

Exclusion Criteria

• Women of below 18 years and above 45 years age group.
• Women with history of diabetes mellitus.
• Women with malignancy or those on cancer chemotherapy.
• Women with chroic liver disease,chroic renal disease.
• Women with HIV infection and those on immunosuppressive therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the effectiveness of the probiotic strains having Lactobacillus rhamnosus GR -1 and Lactobacillus reuteri RC-14 in the management of lower genital infections(bacterial vaginosis as an integral therapy with antibiotics.	one year

Secondary Outcome Measures

Name	Time	Method
Assess the effectiveness of probiotics in maintaining a healthy genital flora throughout the treatment period	one year

Trial Locations

Locations (1)

OPD of Obstetrics & Gynaecology,Sree Avittom Thirunal Hospital (SATH); 🇮🇳 Thiruvananthapuram, KERALA, India

OPD of Obstetrics & Gynaecology,Sree Avittom Thirunal Hospital (SATH)

🇮🇳Thiruvananthapuram, KERALA, India

Dr Rukshana Shamshu

Principal investigator

9495703495

rukshanaimtyaz@gmail.com