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Clinical Trials/ACTRN12612001192875
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.

Registry
who.int
Start Date
November 13, 2012
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
niversity of South Australia

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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