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CTRI Number  CTRI/2024/11/076679 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of 12 weeks probiotic therapy on cardiovascular risk in women with polycystic ovary syndrome 
Scientific Title of Study   Effect of 12 weeks adjuvant probiotic supplementation on cardiovascular autonomic function in women with polycystic ovary syndrome - a randomized double-blind placebo-controlled trial 
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 D Devi  
Designation  Junior Resident  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research  
Address  Department of Physiology, First floor, JIPMER Academic center, JIPMER,Dhanvantari Nagar, Puducherry.
74,Throwbathiamman Kovil street, Ariyankuppam,Puducherry 605007.
Pondicherry
PONDICHERRY
605006
India 
Phone  7395895493  
Fax    
Email  devidevanathan29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saranya k 
Designation  Additional Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research  
Address  Department of Physiology, First floor, JIPMER Academic center, JIPMER,Dhanvantari Nagar, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  7373240899  
Fax    
Email  ktsaran28@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr D Devi  
Designation  Junior Resident  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research  
Address  Department of Physiology, First floor, JIPMER Academic center, JIPMER,Dhanvantari Nagar, Puducherry.
74,Throwbathiamman Kovil street, Ariyankuppam,Puducherry 605007.
Pondicherry
PONDICHERRY
605006
India 
Phone  7395895493  
Fax    
Email  devidevanathan29@gmail.com  
 
Source of Monetary or Material Support  
JIPMER Intramural Research Fund JIPMER Dhanvantari Nagar Puducherry 605006 
 
Primary Sponsor  
Name  JIPMER Intramural Research Fund 
Address  JIPMER Dhanvantari Nagar Puducherry 605006 
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 
DrDDevi  JIPMER  0PD No. 6030, Department of Obstetrics and gynaecology, women and child hospital block JIPMER
Pondicherry
PONDICHERRY 
07395895493

devidevanathan29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Interventional Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N970||Female infertility associated withanovulation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  placebo capsule  Women with PCOS will receive standard therapy along with placebo capsule (maltodextrin) once daily for 3 months. 
Intervention  probiotic capsule  Women with PCOS will receive the standard therapy along with Probiotic capsule [L. acidophilus, L. rhamnosus, L. reuteri (each 2 billion CFU); L. plantarum, L. casei, L. fermentum, Bifidobacterium bifidum (each 1 billion CFU) and fructo-oligosaccharides (100 mg)] once daily for 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Women with PCOS visiting Obstetrics and Gynecology OPD, aged 18 to
35 years, diagnosed as per Rotterdam‟s criteria with the presence of any
two of the following: 1) Oligomenorrhea/ dysmenorrhea 2) Clinical &/or
biochemical Hyperandrogenism, 3) Polycystic ovarian morphology on
ultrasound. 
 
ExclusionCriteria 
Details  Women with endocrine disorders, morbid obesity, known CVD, any
hormonal therapy, drugs affecting autonomic nervous system, pregnancy,
women actively engaged in any physical activity such as yoga, exercise
and known GI disorders will be excluded. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in heart rate , blood pressure, Autonomic function test and Baroreceptor reflex sensitivity, Body composition parameters   The parameters are recorded at the baseline and at the end of 12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Metabolic profile (Serum glucose, Serum Insulin, HOMA IR, Lipid
profile), Inflammatory marker (TNF-α), Serum testosterone,
Body composition parameters (Body fat mass (kg & %), Lean body mass
(kg & %), BFMI, FFMI, FTLM ratio) 
Baseline & 12 Weeks 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   28/11/2024 
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="2"
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  

Registered patients from Obstetrics and Gynecology OPD JIPMER aged between 18 to 35 years will be recruited as per inclusion and exclusion criteria . After obtaining written consent ,the participants will be requested to reach the Department of Physiology after overnight fasting at around 8 am. Five ml of fasting blood sample will be collected to estimate metabolic and vascular markers. Demographic and clinical details will be collected. Anthropometric measurements and body composition analysis will be done. Following this cardiovascular autonomic function tests will be done. The baseline recording of the parameters for all the groups will be done during recruitment. The PCOS women allotted to groups 1 & 2 will be asked to continue their standard treatment along with probiotic or placebo therapy for 12 weeks. Women in group 1 will receive probiotic capsule [L. acidophilus, L.rhamnosus, L. reuteri (each 2 billion CFU); L. plantarum, L. casei, L. fermentum, Bifidobacterium bifidum (each 1 billion CFU) and fructo-oligosaccharides (100 mg)] once daily for 12 weeks. In addition to standard therapy while women in group 2 will be receiving placebo drug once daily along with standard therapy for 12 weeks. Placebo will be prepared using starch which will be made into capsules (maltodextrin) drug. While probiotic capsules will be purchased from GMP certified pharmaceutical company. Both capsules will be ensured to look alike to each other. All recruited women will be given add on drugs for a period of 12 weeks and follow up will be done. Drug adherence will be assessed by pill count method or through telecommunication . At the end of twelve weeks, the participants of both the groups will be asked to report to the department laboratory for the second recording (post-interventional) of the study parameters.

 
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