Not Yet RecruitingPhase 1ACTRN12612001192875

Probiotics to initiate ovulation in women with PolyCystic Ovarian Syndrome (PCOS) and Irritable Bowel Syndrome (IBS)

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)


Sponsor

University of South Australia

Enrollment

16 participants

Start Date

Dec 1, 2012

Study Type

Interventional

Conditions

Summary

Polycystic ovary syndrome (PCOS) is the most common cause for women experiencing menstrual irregularity and anovulation (not releasing an egg each month), affecting up to 10% of the population. While the cause for PCOS is not fully understood, certain probable links have been identified. Almost half the individuals with PCOS have an excess of adipose (fat) tissue stored around their waist, impaired sugar metabolism (insulin resistance) and high levels of fats / cholesterol in their blood stream (dyslipidemia). The excess fat tissue is believed to activate the bodies immune system, causing inflammation which then stops ovulation and increases the ovaries production of testosterone. It is this raised testosterone that may cause acne and excess body hair- a common feature of PCOS. Being over weight and a diet high in saturated fat have both been independently linked with inflammation. Furthermore, women with PCOS are known to have signs of increased inflammation in their body compared to healthy women without PCOS. Work by our group has shown that individuals with PCOS have less than ideal diets, with high intakes of saturated fat, and a higher body mass index (BMI) than aged matched fertile counterparts. Other groups have also shown that PCOS patients have a high saturated fat intake. We have previously proposed that a high fat / low fibre diet will create disturbances in bowel bacteria, with an overgrowth of “bad” bacteria which can then pass across the gut wall into the blood stream and activate the woman’s immune system. The resulting inflammation is known to produce insulin resistance with resulting high blood levels of insulin interfering with normal egg development and ovulation, while driving up the ovaries production of testosterone, potentially causing acne and excess body hair. Probiotics are “good” or beneficial bacteria that are present in food sources such as yogurt, fermented milk drinks or can be taken as powder and capsule supplements. Probiotics are useful treatments for gastro-intestinal conditions such as constipation, antibiotic associated diarrhoea and irritable bowel syndrome (IBS). All of these clinical conditions are linked with an increase in “bad” bacteria in the gut and have been shown to cause inflammation in the gut and in the rest of the body. Probiotic “good” bacteria have the ability reduce the number of “bad” bacteria in the gut, while also helping stop these “bad” bacteria passing through the gut wall into the blood stream where they can activate inflammation. Therefore, we propose that by giving probiotic “good” bacteria supplements to women with PCOS and symptoms of excess “bad” bacteria in their gut (bloating, pain, constipation or diarrhoea) we may be able to reduce inflammation in the body, thereby reducing insulin and testosterone levels and re-starting ovulation. This is the primary research question of this study.


Eligibility

Sex: FemalesMin Age: 20 YearssMax Age: 39 Yearss

Inclusion Criteria3

  • Presence of PolyCystic Ovarian Syndrome based on the Rotterdam Criteria
  • Presence of Irritable Bowel Syndrome based on the Rome III criteria
  • waist circumference > 88 cm (marker of insulin resistance)

Exclusion Criteria6

  • Non functional bowel disorder (e.g. inflammatory bowel disease, diverticulitis, colon cancer).
  • Autoimmune disease (e.g. SLE, rheumatoid arthritis)
  • active infection
  • hormonal contraception
  • medication that may effect the bowel flora (e.g. antibiotics, laxatives).
  • immuno-supressive medication (excluding topical or inhaled corticosteroids).

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Interventions

4 weeks oral ingestion of both : 1. soluble fibre in water (5 gm in 200 ml warm water once daily). 2. two probiotic capsules per day (Metagenics Ultra Flora Restore). Each capsule contains 25 billio

4 weeks oral ingestion of both : 1. soluble fibre in water (5 gm in 200 ml warm water once daily). 2. two probiotic capsules per day (Metagenics Ultra Flora Restore). Each capsule contains 25 billion organisms, including 12.5 Billion Lactobacillus acidophilus NCFM, 12.5 Billion bifidobacterium Lactis Bi-07, 5 Billion lactobacilus rhamnosus and 5 Billion Saccharomyces cerevisiae organisms


Locations(1)

Australia

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