| CTRI Number |
CTRI/2024/11/076726 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Other |
|
Public Title of Study
|
TO STUDY THE EFFICACY OF PROBIOTIC SUPPLEMENTATION ON OBESITY LIPID PROFILES AND INSULIN RESISTANCE IN WOMEN WITH PCOS
|
|
Scientific Title of Study
|
TO STUDY THE EFFICACY OF PROBIOTIC SUPPLEMENTATION ON OBESITY LIPID PROFILES AND INSULIN RESISTANCE IN WOMEN WITH PCOS
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| rutu10 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RUTUJA BODAKE |
| Designation |
PG STUDENT |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER SHRI BANGARAMMA CAMPUS VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
9082766926 |
| Fax |
|
| Email |
bodakerutuja10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAILAJA R BIDRI |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER SHRI BANGARAMMA CAMPUS VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
9880162550 |
| Fax |
|
| Email |
drsrbidri1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RUTUJA BODAKE |
| Designation |
PG STUDENT |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER SHRI BANGARAMMA CAMPUS VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
9082766926 |
| Fax |
|
| Email |
bodakerutuja10@gmail.com |
|
|
Source of Monetary or Material Support
|
| OBG OPD 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE VIJAYAPURA KARNATAKA 586103 |
|
|
Primary Sponsor
|
| Name |
DR RUTUJA BODAKE |
| Address |
OPD NO 2 SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SHRI BANGARAMMA CAMPUS VIJAYAPURA 586103 |
| 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 RUTUJA BODAKE |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL and RESEARCH CENTER |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL and RESEARCH CENTER SHRI BANGARAMMA CAMPUS VIJAYAPURA 586103
Bijapur
KARNATAKA |
9082766926
bodakerutuja10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical clearance committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PROBIOTIC |
AFTER 12 WEEKS POST INTERVENTIONAL ANTHROPOMETRIC AND LAB PARAMETERS WILL BE NOTED |
| Intervention |
PROBIOTIC |
ANTHROPOMETRIC PARAMETERS
BMI
WEIGHT
HEIGHT
WAIST CIRCUMFERENCE
HIP CIRCUMFERENCE
LAB PARAMETERS
LIPID PROFILE
FASTING SERUM INSULIN
FASTING BLOOD SUGAR FBS
PRE INTERVENTIONAL ANTHROPOMETRIC AND LAB PARAMETERS WILL BE NOTED
PROBIOTICS WILL BE PRESCRIBED FOR 12 WEEKS
AFTER 12 WEEKS POST INTERVENTIONAL ANTHROPOMETRIC AND LAB PARAMETERS WILL BE NOTED
PRE AND POST INTERVENTIONAL PARAMETERS WILL BE COMPARED
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
40.00 Day(s) |
| Gender |
Female |
| Details |
women diagnosed with PCOS with BMI more than 25 |
|
| ExclusionCriteria |
| Details |
Presently on probiotic supplements
Endocrine disorders, such as diabetes, thyroid, and poor glucose tolerance.
K/c/o GI disorders (irritable bowel syndrome, celiac disease, and food allergies)
K/c/o autoimmune disease.
Probiotic capsules allergy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probiotic supplementation may improve lipid metabolism disturbances weight BMI insulin HOMA IR and hormonal profiles associated with PCOS indicating its potential role to protect fertility |
Probiotic supplementation for 12 weeks may improve lipid metabolism disturbances weight BMI insulin HOMA IR and hormonal profiles associated with PCOS indicating its potential role to protect fertility |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| probiotic supplementation to improve hormonal parameters |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="106" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/11/2024 |
| Date of Study Completion (India) |
30/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The following study will include women diagnosed with PCOS as per modified Rotterdam criteria in the age group of 18-40 yrs visiting the OBG OPD in SHRI BM Patil medical college and R C with BMI > 25 after considering inclusion and exclusion criteria patients with enrolled
pre interventional investigations will the collected anthropometric parameters such as BMI height weight waist circumference hip circumference
lab parameters such as lipid profile, fasting blood glucose, fasting insulin level
Probiotics will be prescribed for 12 weeks
after 12 weeks post interventional parameters will be noted
|