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CTRI Number  CTRI/2015/04/005714 [Registered on: 24/04/2015] Trial Registered Prospectively
Last Modified On: 14/07/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study of capsule containing lactobacillus strains in adult women subjects suffering from Bacterial Vaginosis. 
Scientific Title of Study   A Prospective, Randomized, Double blind, parallel group, Placebo controlled clinical study of capsule containing lactobacillus strains in adult women subjects suffering from Bacterial Vaginosis. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
SCR/017/MB/2015 Version Number 1.0 Dated 24 Feb 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudha Marwah 
Designation  Principal Investigator 
Affiliation  Spectrum Healthcare 
Address  81 - 84 Lady Ratan Tata Medical & Research Centre, M. Karve Road,Cooperage

Mumbai
MAHARASHTRA
400021
India 
Phone  02222846357  
Fax  02222846804  
Email  smarwah@spectrumhealthcare.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudha Marwah 
Designation  Principal Investigator 
Affiliation  Spectrum Healthcare 
Address  81 - 84 Lady Ratan Tata Medical & Research Centre, M. Karve Road,Cooperage

Mumbai
MAHARASHTRA
400021
India 
Phone  02222846357  
Fax  02222846804  
Email  smarwah@spectrumhealthcare.co.in  
 
Details of Contact Person
Public Query  
Name  Sanjay Vekariya 
Designation  Manager 
Affiliation  Spectrum Clinical Research 
Address  401, Kshamalaya Building, 37, New Marine Lines, Mumbai

Mumbai
MAHARASHTRA
400020
India 
Phone  02240645100  
Fax  02266155567  
Email  svekariya@spectrumcr.com  
 
Source of Monetary or Material Support  
Microbax India Limited, Sy. No. 59, Nandigama Village, Patancheru Mandal, Medak District, Telangana India 
 
Primary Sponsor  
Name  Spectrum Clinical Research Pvt Ltd 
Address  401 - Kshamalaya Building, 37, New Marine Lines, Mumbai - 400020, India 
Type of Sponsor  Contract research organization 
 
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 Sudha Marwah  Spectrum Healthcare  81 - 84 Lady Ratan Tata Medical & Research Centre, M. Karve Road,Cooperage, Mumbai
Mumbai
MAHARASHTRA 		 02222846357
02222846804
smarwah@spectrumhealthcare.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ClinXXL Independent Ethics Committee, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Bacterial Vaginosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lactobacillus Capsule  Lactobacillus spp. For oral application in capsule form to be once taken daily for 4 weeks 
Comparator Agent  Placebo  oral application in capsule form to be once taken daily for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Symptoms of vaginal discharge with Bacterial Vaginosis diagnosed by Amsel’s criteria.
2. Asymptomatic but on clinical examination presence of abnormal vaginal discharge with Bacterial Vaginosis diagnosed by Amsel’s criteria.
3. Willing to participate in the study after informed consent.
 
 
ExclusionCriteria 
Details  1.Menopausal women
2.Pregnant women
3.Malignancy of reproductive tract
4.Less than 6 weeks since last delivery and abortion
5.H/O severe allergic reaction
6.Immuno compromised state
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of IP in cases of bacterial vaginosis  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety of IP in cases of bacterial vaginosis  4 weeks 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/04/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is Prospective, Randomized, Double blind, parallel group, Placebo controlled clinical study of capsule containing lactobacillus strains in adult women subjects suffering from Bacterial Vaginosis.

Adult female subjects will be screened for presence bacterial vaginosis using Amsel’s criteria after obtaining written informed consent. Eligible subjects will be randomized to either of the two groups – Group 1 (Test group) or Group 2 (Placebo group) using computer generated randomization schedule. Enrolled subjects will be provided capsules for daily consumption for 4 weeks according to their randomization sequence along with the instructions of use. Safety and efficacy assessment will be done on day 7, 14, 28, 42 and 56. Investigational product compliance will be checked on days 7, 14 and 28 by counting the number of capsules consumed and time since last visit.

 
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