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CTRI Number  CTRI/2022/10/046723 [Registered on: 21/10/2022] Trial Registered Prospectively
Last Modified On: 29/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Health functional food]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Probiotic on Bacterial Vaginosis 
Scientific Title of Study   A Double blind, Randomized, Placebo-controlled, Parallel Clinical Trial to Evaluate the Clinical Efficacy and Safety of Vaginal Probiotic Capsule (LABTHERA-001) in patients with Bacterial Vaginosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
21PR0068-008 Version 1.1 Date 13 June 2022  Protocol Number 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunitha B 
Designation  Obstetrician & Gynaecologist 
Affiliation  Milann Hospital 
Address  # 1109, 24th main road, TMC layout, 1st Phase J P Nagar, Bengaluru, Karnataka

Bangalore
KARNATAKA
560078
India 
Phone  9845354608  
Fax    
Email  dr.sunithamahesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jang Yul Kwak 
Designation  Director 
Affiliation  Syncorp Health Pvt Ltd 
Address  Building # 06, 3rd floor 2nd Main Road, opposite to British Biologicals, Sarvobhogam Nagar, Arekere, Bengaluru, Karnataka

Bangalore
KARNATAKA
560076
India 
Phone  8970888899  
Fax    
Email  deankwak@syncorp.in  
 
Details of Contact Person
Public Query  
Name  Subham Dutta 
Designation  Director  
Affiliation  Syncorp Health Pvt Ltd 
Address  Building # 06, 3rd floor 2nd Main Road, opposite to British Biologicals, Sarvobhogam Nagar, Arekere, Bengaluru, Karnataka

Bangalore
KARNATAKA
560076
India 
Phone  08049774772  
Fax    
Email  subham.dutta@syncorphealth.com  
 
Source of Monetary or Material Support  
Research Mentor Co. Ltd, 905, SKV1 tower, 25, Yeonmujang 5 ga-gil, Seongdong-gu, Seoul, Republic of South Korea 
 
Primary Sponsor  
Name  Atogen Co., Ltd. 
Address  #201, 11-8, Techno 1-ro, Yuseong-gu, Daejeon, 34015 Republic of South Korea 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anu Sadashiv B  Milann fertility & birthing hospital  Room No. 4, Ground Floor, Department of Obstetrician & Gynaecologist, #07, E Park Road, Kumara park east, Seshadri Puram, Bengaluru, Karnataka - 560001
Bangalore
KARNATAKA 		 9945508681

sadaanu@gmail.com 
Dr Sunitha B  Milann Hospital  Room No 5, Ground Floor, Department of Obstetrician & Gynaecologist, # 1109, 24th main road, TMC layout, 1st Phase J P Nagar, Bengaluru, Karnataka - 560078
Bangalore
KARNATAKA 		 9845354608

dr.sunithamahesh@gmail.com 
Dr Premlata B Kamalapur  Sanjeevini Hospital  Room No 7, Ground Floor, Department of Obstetrician & Gynaecologist, # 761, 7th Main Road, Last Bus stop, Mahalakshmi layout, Bengaluru, Karnataka - 560086
Bangalore
KARNATAKA 		 9845699687

drpremalata@sanjeevinihospital.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Milann fertility & birthing hospital Institutional Ethics Committee  Approved 
Milann Hospital Institutional Ethics Committee  Approved 
Sanjeevini Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LABTHERA-001 Intravaginal Capsule   Group A: LABTHERA-001 Capsule : 6×10 to the power of 9 CFU Once daily at night for 7 consecutive days followed by twice a week at night for 3 weeks. Group B: LABTHERA-001 Capsule : 1×10 to the power of 9 CFU Once daily at night for 7 consecutive days followed by twice a week at night for 3 weeks. 
Comparator Agent  Placebo  Capsule 0 CFU Once daily at night for 7 consecutive days followed by twice a week at night for 3 weeks. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Non-pregnant, non-breastfeeding females between the ages of 20 and 45 years, inclusive willing to participate in study and provide written informed consent.
2. Women of childbearing potential must agree to practice reliable contraception for the 28-day period before enrollment through 30 days following treatment.
3. Agree to abstain from sexual intercourse 24 hours before each visit and 6 hours after IP insertion and agrees to follow medically acceptable method of contraception.
4. Presenting with signs of Bacterial Vaginosis (as per Amsel Criteria).
5. Vaginal specimen should have a Nugent score of greater than or equal to 4
6. Women who are currently not menstruating or expected not to have menstruation within 17 days from screening
7. Able to understand and comply with planned study procedures
8. Willing to abstain from insertion of tampons, douches, or other intravaginal medications or objects during study
9. Negative serum or urine pregnancy test
10. Provide written informed consent before initiation of any study procedures and be available for all study visits
11. No known history of HIV
12. Have a refrigerator to store the investigational product 
 
ExclusionCriteria 
Details  1)Potential participants who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study
2)Patients with vaginal, vulvar, or genitourinary condition that, according to the Investigators
14)Any other condition that in the opinion of the investigator does not justify the patient’s participation in the study

judgement, may confound the interpretation of clinical response based on Liquid Based Cytology
3)Patients with a history of regional enteritis, ulcerative colitis, or a history of C. difficile associated diarrhea
4)Patients with known current drug or alcohol abuse that could impact study compliance
5)Mixed vaginal infections, including bacterial vaginosis and trichomoniasis or coexistent infections with genital herpes and cervicitis based on Liquid Based Cytology
6)Self-reported abnormal Papanicolaou smear (grade 3 or more) in the preceding 12 months
7)History of diabetes mellitus
8)Immunocompromised patients, including those with human immunodeficiency virus seropositivity or with clinically diagnosed acquired immunodeficiency syndrome or its related complex as per HIV test
9)Patients who had taken oral or intravenous antifungal agents within 4weeks or used topical vaginal antifungal drugs within 1 week before enrollment
10)Terminally ill patients or patients with severe cardiac (creatine kinase values >3 X upper limit of normal laboratory values), hepatic (AST, ALT values >3 X upper limit of normal laboratory values) renal (creatinine > 2mg/dl) or history of cerebrovascular disease, malignancy, chronic uncontrolled systemic disease e.g., hypertension, collagen disorders, etc. or any other serious medical illness.
11)Patients with known sensitivity to any of the active or inactive ingredients in the study drug
12)Patients with a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or study treatment administration or could interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the patient inappropriate for entry into the trial.
13)Patients who have participated in a new drug study in the past 3 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in Amsel Criteria
2. Reduction in Nugent Score
3. Microbiome restoration through vaginal specimen
4. LABTHERA-001 colonization through qPCR  		 1. Visit 1,2,3,4,5,6 and 7
2. Visit 1,2,3,4,5,6 and 7
3. Visit 1,2,3,4,5,6 and 7
4. Visit 1,2,3,4,5,6 and 7 
 
Secondary Outcome  
Outcome  TimePoints 
Number of positive Bacterial Vaginosis  Visit 1,2,3,4,5,6 and 7
 
Number of negative Bacterial vaginosis  Visit 1,2,3,4,5,6 and 7 
Acceptability of treatment
a. Proportion of participants who comply with the
complete dose regimen in each study arm as assessed
by subject reporting through diary card
b. Self-administered questionnaire about acceptability
of the study product in each study arm
 		 Visit 1,2,3,4 and 5 
Tolerability of treatment:Tolerability will be assessed by proportion of participants
who discontinue investigational product early in each
study arm due to local adverse events (local adverse
events includes signs and symptoms of vaginal origin)
 		 Visit 1,2,3,4 and 5 
Improvement in self-reported vaginal signs and symptoms
will be assessed for vaginal itch, vaginal burning, itch of
external genitals, burning of external genitals, vaginal
discharge, urination disorder and painful intercourse on a
scale of 0 to 10 (0: absence of signs and symptoms & 10:
maximum discomfort)  		 Visit 1,2,3,4,5,6 and 7 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   31/10/2022 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Bacterial vaginosis (BV) is an infection of the vagina characterized by overgrowth of certain types of bacteria which leads to change in normal balance of vaginal microbiome. The signs and symptoms of Bacterial Vaginosis includes thin, grey, white or green vaginal discharge, foul-smelling "fishy" vaginal odor, vaginal itching or burning sensation during urination. The rationale of this study is to evaluate the clinical efficacy and safety of vaginal probiotic capsule (LABTHERA-001) in Bacterial Vaginosis. 
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