Clinical Trial: Gut Microbiome in Patients With Polycystic Ovary Syndrome
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: The Effect of Diet on the Microbiome of Women With Polycystic Ovary Syndrome
Brief Summary: The polycystic ovary syndrome is intimately associated with body weight and nutrition.The genomic era did not bring a breakthrough to the understanding of the syndrome. The recent surge of studies on gut microbiome has raised the possibility that the specific diet, which often affect these women favorably, would change their gut microbiome. Hence, the investigators will examine their gut microbial population in comparison to normal ovulatory women and then examine whether a low carbohydrate diet causes favorable change in their gut microbial population.
Detailed Summary:
- Scientific Background
Infertility is a major health problem that affects up to 15% of married couples. About half of these cases are attributable to female factors, among which anovulation is the leading cause. About 5% of all women of reproductive age are anovulatory due to the polycystic ovarian syndrome (PCOS). In addition to its effect on fertility, PCOS causes major health and cosmetic problems and significantly affects quality of life in women. PCOS is associated with cardiovascular morbidity and Type 2 diabetes mellitus, but it is unclear whether these are caused by the ovarian dysfunction or result from a common denominator.
- PCOS
- The clinical picture:
The polycystic ovary syndrome consists of anovulation, acne, hirsutism (resulting from hyperandrogenism), and reversed serum LH to FSH ratio. A large proportion of women with PCOS are overweight, and a significant proportion of women with PCOS have decreased peripheral insulin sensitivity. The direct cause to this insulin resistance is still enigmatic. All these features place women with PCOS as a group of patients related to the metabolic syndrome. Baranova et al. (2011) even stated that "it seems appropriate to consider polycystic ovary syndrome as the ovarian manifestation of metabolic syndrome".
- Genetics
Not all women with PCOS have affected relatives but familial clusters are common, and brothers of women with PCOS have high serum levels of the androgen dehydroepiandrosterone sulfate. The eventual clinical expression of PCOS results not only from genetic predisposition but also from nutritional factors. Family studies using sever
Sponsor: Meir Medical Center
Current Primary Outcome: change in microbial population of the colon [ Time Frame: 2 months of diet ]
Original Primary Outcome: change in microbial populatyion of the colon [ Time Frame: 2 months of diet ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Meir Medical Center
Dates:
Date Received: March 3, 2014
Date Started: April 2014
Date Completion: March 2016
Last Updated: March 10, 2014
Last Verified: March 2014
