CTRI Number |
CTRI/2013/01/003337 [Registered on: 29/01/2013] Trial Registered Prospectively |
Last Modified On: |
07/05/2014 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Probiotic |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Effect of Probiotics Supplementation on Bacterial Vaginosis in pregnant women |
Scientific Title of Study
|
EFFECT OF PROBIOTICS SUPPLEMENTATION ON BACTERIAL VAGINOSIS (BV) IN PREGNANT WOMEN |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIN/2012/01, version: 01; Dated 08/11/2012 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Hemalatha R |
Designation |
Deputy Director/ scientist E |
Affiliation |
NATIONAL INSTITUTE OF NUTRITION |
Address |
National Institute of Nutrition (ICMR) Jamai Osmania Hyderabad National Institute of Nutrition ICMR Jamai Osmania Hyderabad Hyderabad ANDHRA PRADESH 500007 India |
Phone |
040-27197297 |
Fax |
040-27019074 |
Email |
rhemalathanin@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Hemalatha R |
Designation |
Deputy Director/ scientist E |
Affiliation |
NATIONAL INSTITUTE OF NUTRITION |
Address |
National Institute of Nutrition (ICMR) Jamai Osmania Hyderabad National Institute of Nutrition ICMR Jamai Osmania Hyderabad Hyderabad ANDHRA PRADESH 500007 India |
Phone |
040-27197297 |
Fax |
040-27019074 |
Email |
rhemalathanin@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Hemalatha R |
Designation |
Deputy Director/ scientist E |
Affiliation |
NATIONAL INSTITUTE OF NUTRITION |
Address |
National Institute of Nutrition (ICMR) Jamai Osmania Hyderabad National Institute of Nutrition ICMR Jamai Osmania Hyderabad Hyderabad ANDHRA PRADESH 500007 India |
Phone |
040-27197297 |
Fax |
040-27019074 |
Email |
rhemalathanin@yahoo.com |
|
Source of Monetary or Material Support
|
NATIONAL INSTITUTE OF NUTRITION HYDERABAD |
|
Primary Sponsor
|
Name |
INDIAN COUNCIL OF MEDICAL RESEARCH |
Address |
INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR) V RAMALINGASWAMI BHAWAN ANSARI NAGAR POST BOX NO 4911 NEW DELHI 110029 |
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DR R HEMALATHA |
Clinical and microbiology division NIN |
National Institute of Nutrition, ICMR Tarnaka Hyderabad ANDHRA PRADESH |
040-27197297 040-27019074 rhemalathanin@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICAL COMMITTEE NATIONAL INSTITUTE OF NUTRITION (ICMR) MINISTRY OF HEALTH AND FAMILY WELFARE GOVERNMENT OF INDIA |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Pregnant woman in their third trimester with Bacterial vaginosis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Lactobacillus rhamnosusGR-1
Lactobacillus reuteri RC-14 |
at a dose of 2-5x108 CFU/day orally will be administered daily till delivery from 28th week of gestational age along with antibiotic treatment for 7 days for BV |
Comparator Agent |
Placebo capsules |
will be administered orally one capsule daily till delivery from 28th week of gestational age along with antibiotic treatment for 7 days for BV |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Female |
Details |
1.Pregnant woman in their third trimester with BV
2.Age 18 years and above
3.Signed Informed Consent |
|
ExclusionCriteria |
Details |
1. 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. Patient not willing to comply with the clinical study instructions |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Cure rate of BV in women with and without probiotics
|
Assesed for BV cure by 38th week of gestation |
|
Secondary Outcome
|
Outcome |
TimePoints |
Rate of recurrence of BV with probiotics |
3 month post partum |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
01/03/2013 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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 Nugent’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-14) 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. |