| 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
|
|
|
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
|
|
|
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. |