| CTRI Number |
CTRI/2025/08/092976 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Alterations in gut microbiome in PCOS |
|
Scientific Title of Study
|
Comparison of gut microbiome in patients with PCOS versus Controls: A Cross-sectional study |
| 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. Nikhil Bhagwat |
| Designation |
Professor and Head of Department, Department of Endocrinology |
| Affiliation |
TNMC AND NAIR HOSPITAL |
| Address |
419, 4TH FLOOR, COLLEGE BUILDING, DEPARTMENT OF ENDOCRINOLOGY, TNMC AND NAIR HOSPITAL, MUMBAI CENTRAL, MUMBAI
Mumbai MAHARASHTRA 400008 India |
| Phone |
9820238399 |
| Fax |
|
| Email |
bhagwatnik@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Ashmika Jain |
| Designation |
Senior resident |
| Affiliation |
TNMC AND NAIR HOSPITAL |
| Address |
419, 4TH FLOOR, COLLEGE BUILDING, DEPARTMENT OF ENDOCRINOLOGY, TNMC AND NAIR HOSPITAL, MUMBAI CENTRAL, MUMBAI
Mumbai MAHARASHTRA 400008 India |
| Phone |
9820238399 |
| Fax |
|
| Email |
ashmika18jain@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Nikhil Bhagwat |
| Designation |
Professor and Head of Department, Department of Endocrinology |
| Affiliation |
TNMC AND NAIR HOSPITAL |
| Address |
419, 4TH FLOOR, COLLEGE BUILDING, DEPARTMENT OF ENDOCRINOLOGY, TNMC AND NAIR HOSPITAL, MUMBAI CENTRAL, MUMBAI
Mumbai MAHARASHTRA 400008 India |
| Phone |
9820238399 |
| Fax |
|
| Email |
bhagwatnik@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Endocrinology Department Development Fund |
| Address |
419, 4TH FLOOR, COLLEGE BUILDING, DEPT. OF ENDOCRINOLOGY, TNMC AND NAIR HOSPITAL, MUMBAI CENTRAL, MUMBAI, MAHARASHTRA, INDIA 400008 |
| Type of Sponsor |
Government medical college |
|
|
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 NIKHIL BHAGWAT |
TNMC AND NAIR HOSPITAL |
OPD 19, ENDOCRINOLOGY OPD, 1ST FLOOR, OPD BUILDING, TNMC AND NAIR HOSPITAL, MUMBAI CENTRAL, MUMBAI, MAHARASHTRA 400008 Mumbai MAHARASHTRA |
9820238399
bhagwatnik@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR ACADEMIC RESEARCH PROJECTS (ECARP), PG ACADEMIC COMMITTEE, TN MEDICAL COLLEGE AND BYL CHARITABLE NAIR HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood sample |
Blood sample will be collected from each subject at two time points. A fasting blood sample and a post 75 g OGTT (2h hour) blood sample. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
CASES:
ANY FEMALE FULFILLING ROTTERDAM CRITERIA FOR DIAGNOSIS OF PCOS
CONTROLS:
ANY FEMALE WITH REGULAR MENSTRUAL CYCLES |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1.Hyperprolactinemia
2.Thyroid dysfunction
3.Cushing’s syndrome and exogenous steroid therapy
4.Androgen-secreting tumours
5.Non classic congenital adrenal hyperplasia
6.Diabetes Mellitus
7.Patients on treatment for insulin resistance
8.Patients on treatment with oral contraceptive pills
9.Pregnant and lactating females
10.Patients who took antibiotics/ prebiotics in previous 1 month
11.Gastrointestinal disease (Ulcerative Colitis, Crohn’s disease, Malignancy, Colitis, Enteritis)
12.Patients with either acute or chronic systemic illnesses |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare alpha diversity of gut microbiome between
treatment naive PCOS patients with age and BMI matched
controls |
at the completion of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare beta diversity indices of gut microbiome
between treatment naive PCOS patients with age & BMI
matched controls
2. To study correlation between hormonal & metabolic
markers & microbial diversity indices.
3. To study & compare relative abundances of bacteria
between treatment naive PCOS patients with age & BMI
matched controls
4. To study correlation between clinical parameters &
microbial diversity indices. |
At the completion of the study |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
31/08/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
HYPOTHESIS:There is no difference between gut microbiome of PCOS patients and
healthy controls. QUESTION: Is there a difference between gut microbiome of PCOS patients and
healthy controls?
SUMMARY
PCOS affects 5 to 18 % of reproductive age women. It leads to chronic anovulation, infertility, miscarriage as well as increased risk of endometrial cancer, cardiovascular disease, type 2 diabetes mellitus, depression and anxiety. Dysbiosis of gut microbiome (DOGMA) theory claims that altered gut microbiota is responsible for insulin resistance (IR) and chronic inflammation in PCOS. An imbalance between good and bad gut bacteria plays the key role in its pathogenesis. Several studies have shown significant differences in gut microbiota between controls and disease groups. Correlation between microbial diversity indices and metabolic/ hormonal profile has given new insights into pathology of PCOS. Current treatment options include lifestyle changes, insulin sensitizers, sex steroids and gonadotropins have certain disadvantages. Hence, there is scope of indulging into new treatment approaches in PCOS. Modification of the colonic bacterial balance through the use of prebiotics and probiotics has the potential to be an effective treatment of PCOS, with several disadvantages over traditional treatments since it targets the proposed initial pathological insult n the condition - microbiological dysbiosis and resultant leaky gut. There is a paucity of literature regarding altered gut microbiome among patients with PCOS in western India population. Therefore, our study aims to study the gut microbial diversity and its correlation with metabolic/ hormonal profile in this population.
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