| CTRI Number |
CTRI/2026/01/102085 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predict vaginal microbiome profile from metabolites |
|
Scientific Title of Study
|
Predicting microbiome profile and other health related markers from metabolites |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Palok Aich |
| Designation |
Director |
| Affiliation |
MicrobioTx Health Private Limited |
| Address |
363, 8th Main, 3rd Block, Koramangala, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
09019343030 |
| Fax |
|
| Email |
hello@microbiotx.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Palok Aich |
| Designation |
Director |
| Affiliation |
MicrobioTx Health Private Limited |
| Address |
363, 8th Main, 3rd Block, Koramangala, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
09019343030 |
| Fax |
|
| Email |
hello@microbiotx.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Palok Aich |
| Designation |
Director |
| Affiliation |
MicrobioTx Health Private Limited |
| Address |
363, 8th Main, 3rd Block, Koramangala, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
09019343030 |
| Fax |
|
| Email |
hello@microbiotx.com |
|
|
Source of Monetary or Material Support
|
| Funds provided by MicrobioTx Health Pvt Ltd, 8th Main, Koramangala, Bangalore, 560034, India |
| Infrastructure and clinical support provided by Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Medical Rd, Rohtak, Haryana 124001 |
|
|
Primary Sponsor
|
| Name |
MicrobioTx Health Private Limited |
| Address |
363, 8th Main, 3rd Block, Koramangala, Bangalore, 560034 |
| Type of Sponsor |
Other [Startup] |
|
|
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 REETU HOODA |
Pandit B D Sharma Post Graduate Institute of Medical Sciences |
Unit II, Ground Floor, Department of Obstetrics & Gynaecology, Maternal and Child Health Building, PGIMS, Rohtak, Haryana, India
Rohtak
HARYANA |
7988474535
drreetu2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt B. D. Sharma, PGIMS/UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E638||Other specified nutritional deficiencies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
For Infertility group - Married female patients of reproductive age group having an active married life (regular unprotected intercourse, minimum of 12 months) and with a complaint of being unable to conceive for 1 year.
For the control group - females with a history of at least 1 spontaneous conception and no current history of infertility
|
|
| ExclusionCriteria |
| Details |
Participants with a history of alcohol consumption exceeding 20 grams per day
Participants taking immunosuppressants, tamoxifen, amiodarone and/or perhexiline;
Participants who have taken antibiotics in the last 3 weeks
Current use of vaginal creams or pessary
Inability to conceive due to male infertility
Active genital or gastrointestinal infection
Any active illness, psychological and/or pathological condition or chronic disease that would interfere with study participation in the opinion of the Investigator
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Accuracy of Vaginal Microbiome Test
Accuracy is defined as :
(True Positive + True Negative)/(True Positive + True Negative + False Positive + False negative)
Where
True Positive: Microbe present in NGS and predicted by VMT within a 95% Confidence Interval (CI) of the NGS abundance value
True Negative: Microbe absent in NGS and predicted by VMT within 95% CI of NGS abundance value (i.e., 0)
False Positive: Microbe absent in NGS but predicted by VMT outside 95% CI of NGS abundance value
False Negative: Microbe present in NGS but predicted by VMT within 95% CI of abundance value of 0 |
The single time point at which the data will be analysed will be 52 weeks from the start of the study.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Design probiotic formulation to improve oral microbial health |
The single time point at which the data will be analysed will be 1.5 year from the start of the study.
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The vaginal microbiota assumes a pivotal role in maintaining vaginal health and the prevention of various illnesses. The microbial community of the vaginal flora is highly dynamic in nature, and tends to aggregate into distinct groups. Certain community types have been found to have a higher likelihood of leading to unfavorable reproductive outcomes. For example, populations that exhibit a predominance of Lactobacillus species, have been associated with better vaginal health. Vaginal microbiome has been studied in different indications such as Bacterial vaginosis, infertility, endometriosis etc. Despite recent studies highlighting the association of specific microbiome changes with infertility, vaginal infertility profiling remains limited in its adoption. Vaginal microbiome testing is very expensive, offered by limited players and is time consuming as it involves genomic sequencing.
|