TO SEE WHETHER PROBIOTIC SUPPLEMENTATION IMPROVES HORMONAL PROFILE IN PCOS(POLYCYSTIC OVARIAN SYNDROME)WOME

Phase 2

• Conditions: Health Condition 1: E282- Polycystic ovarian syndrome

• Registration Number: CTRI/2022/09/045302
• Lead Sponsor: JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Newly diagnosed PCOS women by Rotterdamââ?¬•s criteria with

the presence of any two of the following:

I) Oligomenorrhea/ dysmenorrhea.

II) hyperandrogenism/hyperandrogenemia

hirsutism, acne and male pattern baldness

III) polycystic ovarian morphology on USG

Aged 18 to 45 years, whose testosterone is more than 76ng/dl

and are started on standard treatment (Life style

modification/metformin / metformin+ OCP / antiandrogen)

visiting the outpatient Department of Obstetrics and

Gynaecology

Exclusion Criteria

1. Hyperandrogenism due to causes other than polycystic

ovarian syndrome such as Cushingââ?¬•s,

hyperprolactinemia, adrenal tumors and late onset

congenital adrenal hyperplasia.

2. Inflammatory bowel disease and cancers in GIT

(carcinoid syndrome)

3. Major surgery in the GIT (colostomy, Whipple

procedure)

4. Chronic diseases like thyroid dysfunction, SLE and

other autoimmune disorders.

5. Past history of antibiotics usage within a period of last

one month.

6. Pregnancy and lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TO look for a decrease in serum total testosterone levelTimepoint: baseline value and after 3 months

Secondary Outcome Measures

Name	Time	Method
to look for values like MDA( malondialdehyde), TAC(total antioxidant capacity) and hsCrp(high sensitive C reactive protein)Timepoint: baseline value and after 3 months