| CTRI Number |
CTRI/2025/09/094113 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study exploring How Probiotics and Metformin Works to Improve PCOS patient Health |
|
Scientific Title of Study
|
Synergistic Effects of Probiotic Supplementation and Metformin on Inflammatory and Metabolic Biomarkers in Women With PCOS |
| 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 Bhuvaneswari |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Biochemistry
All India Institute of Medical Sciences
Sijua, Patrapada, Bhubaneswar, Odisha
Sijua, Patrapada, Bhubaneswar, Odisha
Khordha
ORISSA
751019
India |
| Phone |
8190045235 |
| Fax |
|
| Email |
dr.bhuvana96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suchanda Sahu |
| Designation |
Additional Professor and Guide |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Biochemistry
All India Institute of Medical Sciences
Sijua, Patrapada, Bhubaneswar, Odisha
Khordha
ORISSA
751019
India |
| Phone |
9438884031 |
| Fax |
|
| Email |
biochem_suchanda@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suchanda Sahu |
| Designation |
Additional Professor and Guide |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Biochemistry
All India Institute of Medical Sciences
Sijua, Patrapada, Bhubaneswar, Odisha
Khordha
ORISSA
751019
India |
| Phone |
9438884031 |
| Fax |
|
| Email |
biochem_suchanda@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Bhuvaneswari |
| Address |
Department of Biochemistry,
All India Institute of Medical Sciences Sijua, Patrapada, Bhubaneswar, Odisha
751019 |
| Type of Sponsor |
Other [Self] |
|
|
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 Bhuvaneswari |
All India Institute of Medical Sciences |
Department of Biochemistry
Khordha
ORISSA |
8190045235
dr.bhuvana96@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: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
PROBIOTICS |
Each capsule contains
Lactobacillus crispatus 1 billion CFU
Lactobacillus rhamnosus 1 billion CFU
Lactobacillus gasseri 0.3 billion CFU
Lactobacillus jensenii 0.2 billion CFU
2 capsules/ day,
oral,
for 3 months |
| Intervention |
T. METFORMIN |
1000mg/ day
Twice daily
Oral
for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients aged 18-40 years meeting Rotterdam criteria for PCOS
2. Patients willing to participate |
|
| ExclusionCriteria |
| Details |
Patients with diabetes mellitus, hypo or
hyperthyroidism, or Cushing syndrome, or
any other conditions leading to
hyperandrogenism.
2. Patients during pregnancy or lactation
3. Patients taking antibiotics,
probiotics/prebiotics within 3 months or
using oral proton pump inhibitors or
laxatives/drugs for treatment of acne,
alopecia, or hirsutism within 6 months.
4. Any patient on or started on hormonal
treatment during the study period. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in serum/fecal calprotectin and acylated ghrelin levels |
0 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in insulin resistance markers, hyperandrogenism markers |
0 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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 3 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is an open label randomised clinical trial conducted with 138 women who has PCOS assessing the effects of metformin, probiotics and their combination in improving intestinal inflammation and metabolic regulation over 3 months. Secondary outcomes include improvements in insulin resistance, hyperandrogenism markers. |