ACTRN12612001192875
Not yet recruiting
Phase 1
Prospective non-controlled interventional study investigating the use of oral soluble fibre and probiotic formulation to alter metabolic and reproductive function in women with PolyCystic Ovarian Syndrome (PCOS) and Irritable Bowel Syndrome (IBS)
niversity of South Australia0 sites16 target enrollmentNovember 13, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of South Australia
- Enrollment
- 16
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Presence of PolyCystic Ovarian Syndrome based on the Rotterdam Criteria
- •2\. Presence of Irritable Bowel Syndrome based on the Rome III criteria
- •3\. waist circumference \> 88 cm (marker of insulin resistance)
Exclusion Criteria
- •1\. Non functional bowel disorder (e.g. inflammatory bowel disease, diverticulitis, colon cancer).
- •2\. Autoimmune disease (e.g. SLE, rheumatoid arthritis)
- •3\. active infection
- •4\. hormonal contraception
- •5\. medication that may effect the bowel flora (e.g. antibiotics, laxatives).
- •6\. immuno\-supressive medication (excluding topical or inhaled corticosteroids).
Outcomes
Primary Outcomes
Not specified
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