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CTRI Number  CTRI/2024/11/077387 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 20/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of Pre and Probiotics supplementation in Managing Polycystic Ovarian Syndrome 
Scientific Title of Study   Evaluating the efficacy of Pre and Probiotics supplementation in Managing Polycystic Ovarian Syndrome 
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 Preeti Arora 
Designation  Chief Genomic Scientist 
Affiliation  Research Division of Accurate Diagnostics Pvt. Ltd 
Address  Research Division of Accurate Diagnostics Pvt. Ltd., Kothrud, Pune, Maharashtra, India
Kothrud
Pune
MAHARASHTRA
411038
India 
Phone  7304920064  
Fax    
Email  preeticmd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preeti Arora 
Designation  Chief Genomic Scientist 
Affiliation  Research Division of Accurate Diagnostics Pvt. Ltd 
Address  Research Division of Accurate Diagnostics Pvt. Ltd., Kothrud, Pune, Maharashtra, India
Kothrud

MAHARASHTRA
411038
India 
Phone  7304920064  
Fax    
Email  preeticmd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Preeti Arora 
Designation  Chief Genomic Scientist 
Affiliation  Research Division of Accurate Diagnostics Pvt. Ltd 
Address  Research Division of Accurate Diagnostics Pvt. Ltd., Kothrud, Pune, Maharashtra, India
Kothrud

MAHARASHTRA
411038
India 
Phone  7304920064  
Fax    
Email  preeticmd@gmail.com  
 
Source of Monetary or Material Support  
Gupte Hospital and Centre for Research in Reproduction 
 
Primary Sponsor  
Name  Gupte Hospital and Centre for Research in Reproduction 
Address  904 Bhandarkar Rd Ganeshwadi Deccan Gymkhana Pune Maharashtra 411004 
Type of Sponsor  Research institution and hospital 
 
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 Preeti Arora  Gupte Hospital and Centre for Research in Reproduction  Gynaecology Department, Ground Floor
Pune
MAHARASHTRA 		 7304920064

preeticmd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Gupte Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E888||Other specified metabolic disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Microcrystalline Cellulose: A plant-based, inert substance 
Intervention  Probiotic  Probiotic capsule containing 10 billion CFU of strains of Lactobacillus, Streptococcus and Bifidobacterium for 3 months 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  37.00 Year(s)
Gender  Female 
Details  1. Reproductive-aged women (19–37 years) with a confirmed diagnosis of PCOS according to the 2003 Rotterdam criteria and a body mass index (BMI) ≥ 25 kg/m2 were included 
 
ExclusionCriteria 
Details  Subjects with a history of chronic diseases, including diabetes, lung, pancreatic, renal, liver, or cardiovascular disease, thyroid disorders, hyperprolactinemia, Cushing’s syndrome, autoimmune diseases, allergy to probiotic products, use of antibiotics or multivitamin-mineral supplements within the last three months, and following specific diet or physical activity programs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Improvement in insulin resistance.
2. restoration of hormonal balance, with particular attention to changes in androgen levels (such as testosterone) and the luteinizing hormone (LH) to follicle-stimulating hormone (FSH) ratio, alongside other relevant reproductive hormones 		 At baseline and after 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
impact of probiotic supplementation on clinical characteristics (BMI, Hirsutism , Menstrual irregularity)   After 12 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/12/2024 
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   Polycystic ovary syndrome (PCOS) affects 3.6% to 15% of women of reproductive age and is linked to issues like infertility, endometrial cancer, obesity, and metabolic diseases. While the exact cause of PCOS is unknown, insulin resistance, altered gonadotropin signaling, and ovarian dysfunction are involved in its development. Recent studies show that women with PCOS have distinct gut microbiota profiles compared to healthy women, with a bidirectional relationship between gut health and PCOS features. Since gut microbiota affects insulin resistance, obesity, and inflammation—key aspects of PCOS—modulating the gut microbiome is being explored as a new treatment approach alongside traditional pharmacological and lifestyle interventions. 
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