| CTRI Number |
CTRI/2021/01/030536 [Registered on: 18/01/2021] Trial Registered Prospectively |
| Last Modified On: |
25/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Laphre – A vaginal pessary to address bacterial vaginosis |
|
Scientific Title of Study
|
An Academic study to evaluate Laphre – A Vaginal Pessary for treatment of Bacterial Vaginosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Nirmal |
| Designation |
Senior Resident |
| Affiliation |
Narayana Medical College |
| Address |
Department of Obstetrics and Gynecology,2nd floor room no 16, Narayana General Hospital, Narayana Medical College Campus, Nellore 524003, Andhra Pradesh, India
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8925744196 |
| Fax |
|
| Email |
drnehanirmal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M Vasanth Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Medical College |
| Address |
Narayana Translational Research Centre,Room No 3, III Floor, Narayana Medical College, Nellore 524003,
Andhra Pradesh, India
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
7671082496 |
| Fax |
|
| Email |
mvasanth@narayanamedicalcollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sivakumar Vijayaraghavalu |
| Designation |
Professor |
| Affiliation |
Narayana Medical College |
| Address |
Narayana Translational Research Centre,Room No 1,III Floor, Narayana Medical College, Nellore 524003, Andhra Pradesh, India
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8925744196 |
| Fax |
|
| Email |
livshiva@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tenshi Life Care Private Limited, Galaxy 30, 1st Main Rd, 3rd Phase, J.P.Nagar, Bengaluru, Karnataka 560078 |
|
|
Primary Sponsor
|
| Name |
Tenshi Life Care Private Limited |
| Address |
Galaxy 30, 1st Main Rd, 3rd Phase, J.P.Nagar, Bengaluru, Karnataka 560078 |
| Type of Sponsor |
Other [A Probiotic Company ] |
|
|
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 Neha Nirmal |
Narayana Medical College |
Department of Obstetrics and Gynaecology, 2nd floor room no 16, Narayana General Hospital, Narayana Medical College Campus, Nellore 524003 Andhra Pradesh, India.
Nellore
ANDHRA PRADESH |
8925744196
drnehanirmal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N76||Other inflammation of vagina and vulva, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laphre |
vaginal pessary containing two probiotic strains, with each capsule to contain 2 billion cfu of Lactobacillus rhamnosus UBLR-58 and Lactobacillus gasseri UBLG-36 |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Adult, post-menarchal, pre-menopausal women aged 18 years or older
2. Diagnosis of bacterial vaginosis according to Amsels criteria, defined as having at least 3 of the 4 following criteria
a)Thin, white, yellow, homogenous discharge
b) Clue cells on microscopy (more than 20 percent of epithelial cells)
c) pH of vaginal fluid above 4.5
d) Release of fishy odor i.e. a positive whiff test when alkali (10 percent potassium hydroxide solution is added
3. Having decisional capacity and providing written informed consent
4. Negative urine pregnancy test at screening
5. Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
6. Refrain from sexual intercourse or use a condom until Day 7
7. Signed informed consent and willing and able to comply with all study requirements
|
|
| ExclusionCriteria |
| Details |
1. Patients with known or apparent signs of other infectious causes of BV (vulvovaginal candidiasis, Trichomonas vaginalis, Neisseria gonorrhoea, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening
2. Anticipated menstruation during the treatment period (Day 0 till Day 7)
3. Patients who are pregnant or breastfeeding
4. Patients who were treated for bacterial vaginosis within the past 14 days
5. Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the past 14 days
6. Patients who have used pH modifying vaginal products within the last 14 days
7. Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening
8. Known or previous allergy or hypersensitivity to any product constituent
9.Any medical condition that in the Investigator judgments would make the patient unsuitable for inclusion
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study would give an understanding of how the formulation Laphre - vaginal pessary is effective for treating bacterial vaginosis. |
Two months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The clinical observations would help in design and conduct of clinical trials of this formulation for treatment of Bacterial Vaginosis. |
Two months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/01/2021 |
| Date of Study Completion (India) |
16/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
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)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [livshiva@gmail.com].
- For how long will this data be available start date provided 31-05-2021 and end date provided 31-05-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Adult women with confirmed BV presenting to the hospital would be enrolled in the study after obtaining informed consent. The patients would undergo a thorough gynaecological examination and vaginal samples would be taken and analysed. The patients will be then given details on the administration of the investigational product, capsule containing the formulation, which has to be self-administered bid (1-0-1) for 7 days. The patients will be given the investigational product. On Day 7, patients will be re-examined based on Amsel criteria of BV to determine whether BV has been cured and if required prolonged treatment would be advised for additional one week. Patients would be followed up through telephone for 30 days (twice a week) from the last day of visit for any recurrence. Vaginal samples taken at the start and end of study will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing BV symptoms, usability of the vaginal pessary and adverse events (AEs) if any. |