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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  
NIL 
 
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  
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 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  
Status 
Not Applicable 
 
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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