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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Approved/Obtained 
 
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.

 

 
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