| CTRI Number |
CTRI/2025/02/080020 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of probiotics on inflammation and oxidative stress in PCOS women |
|
Scientific Title of Study
|
Effect of Probiotic supplementation on markers of inflammation and oxidative stress in Indian women with PCOS - a randomised open label clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aafia Rashid |
| Designation |
Post Doctoral fellow |
| Affiliation |
Govt Medical College, Srinagar |
| Address |
Ward 11
Department of Medicine
Srinagar
JAMMU & KASHMIR
190010
India |
| Phone |
09796561754 |
| Fax |
|
| Email |
aaffia.rashid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aafia Rashid |
| Designation |
Post Doctoral fellow |
| Affiliation |
Govt Medical College, Srinagar |
| Address |
Ward 11
Department of Medicine
Srinagar
JAMMU & KASHMIR
190010
India |
| Phone |
09796561754 |
| Fax |
|
| Email |
aaffia.rashid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aafia Rashid |
| Designation |
Post Doctoral fellow |
| Affiliation |
Govt Medical College, Srinagar |
| Address |
Ward 11
Department of Medicine
Srinagar
JAMMU & KASHMIR
190010
India |
| Phone |
09796561754 |
| Fax |
|
| Email |
aaffia.rashid@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research,
2nd Floor, IRCS Building, 1, Red Cross Road, New Delhi, India,110001 |
|
|
Primary Sponsor
|
| Name |
Department of Health Research ,ICMR |
| Address |
ICMR Headquarters New Delhi 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aafia rashid |
Govt Medical College ,Srinagar |
Room 3,Ward 11
Department of Medicine
Srinagar
JAMMU & KASHMIR |
91-9796561754
aaffia.rashid@gmail.com |
| Dr Sobia NIsar |
Govt Medical College ,Srinagar |
Room 3 ,Ward 11 ,Department of Medicine
Srinagar
JAMMU & KASHMIR |
9999735118
sobianisar78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee ,GMC ,Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm 1 :
Metformin 1000mg + Multistrain probiotic Capsule |
Subjects will be randomized to receive treatment for a period of 24 weeks as Group 1: Metformin 1000mg once daily + Diet (30-Kcal/Kg/day and 30 minutes brisk walk daily) + Probiotic capsule once a day |
| Comparator Agent |
Arm 2 : Metformin 1000 mg |
Arm 2 will receive Metformin 1000mg once daily + Diet (30-Kcal/Kg/day and 30 minutes brisk walk daily)only |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All women aged 20 to 40 years diagnosed with PCOS by Rotterdam 2003 Criteria |
|
| ExclusionCriteria |
| Details |
Disease like adrenal hyperplasia, hypo/hyperthyroidism, endometriosis, ovarian tumour, etc.Pregnancy,Lactation and use of OCP"s,Steroids and antiandrogens. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will investigate the effect of probiotic supplementation on
1. clinical ,biochemical and hormonal parameters.
2.markers of inflammation
3. oxidative stress levels |
The study subjects will be assessed at baseline, 12 weeks and 24 weeks after supplementation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will also investigate the effect of probiotic supplementation on gut microbiome in PCOS women |
The gut microbiome will be evaluated at baseline , 12 week and 24 week follow up |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Polycystic ovary syndrome (PCOS), the commonest endocrinopathy of reproductive age women manifests with a barrage of metabolic abnormalities including insulin resistance, glucose intolerance, CAD, metabolic syndrome, fatty liver etc. in addition to anovulation and hyperandrogenism. The prevalence of metabolic syndrome is as high as 33% in women with PCOS and has a long-term health consequence such as type 2 diabetes(T2DM), cardio vascular disease (CVD’s), sleep apnea, psychological problems, and cancers. Although the aetiology of PCOS is not completely understood yet, PCOS is considered a multifactorial disorder with various genetic, metabolic, endocrine and environmental factors. There is increasing evidence suggesting that PCOS affects the whole life of a woman, can begin in utero in genetically predisposed subjects, it manifests clinically at puberty, continues during the reproductive years. The multifactorial clinical spectrum of PCOS requires a multifaceted therapeutic approach.Lifestyle intervention, insulin sensitizers, and anti-androgens are the most common therapeutic approaches for the management of PCOS. However, their application depends on the individual clinical manifestations. Recently, modulation of intestinal microbiota equilibrium using probiotics have been suggested as an effective approach. The intestinal microbiota imbalance can lead to increased ovarian androgen production and prevents the spread of the natural follicles of the ovary through chronic inflammatory response and IR. The hypothesis that probiotics may be involved in maintenance of healthy gut microbiota, management of glycemic control, and can modulate inflammatory marker has received much attention. Recent meta analyses among patients with diabetes concluded that probiotics supplementation significantly decreased insulin resistance and HbA1c levels. Probiotics may improve the glycemic control through modulating reducing inflammatory cytokines and upregulation in the expression of peroxisome proliferator-activated receptor gamma gene. A meta-analysis in subjects with T2DM reported significant effects of probiotics biomarkers of inflammation and oxidative stress. However, probiotic supplementation among women with PCOS did not affect CRP levels. Probiotic may affect antioxidant status and hormonal profiles by alleviating insulin resistance and anti-inflammatory properties. Recently, it is stated that probiotic administration in animal models give better effects on metabolic responses and reproductive performance thorough additive actions. There is however scarce data investigating the impact of probiotic supplementation on oxidative stress levels in PCOS women. The present study is therefore designed to assess the effect of probiotic supplementation in combination with metformin on biomarkers of inflammation and oxidative stress in Indian women with PCOS. |