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Gut Microbiome in Patients With Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02078505
Recruitment Status : Unknown
Verified March 2014 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 5, 2014
Last Update Posted : March 11, 2014
Information provided by (Responsible Party):
Meir Medical Center

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Behavioral: diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Diet on the Microbiome of Women With Polycystic Ovary Syndrome
Study Start Date : April 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PCOS after diet
Patients after 2 months of diet
Behavioral: diet
Carbohydrate poor diet

No Intervention: control
Ovulatory women

Primary Outcome Measures :
  1. change in microbial population of the colon [ Time Frame: 2 months of diet ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Study group - no other etiologies for infertility

Exclusion Criteria:

Other etiologies for infertility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02078505

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Contact: Izhar Ben Shlomo, MD 972-52-6124781

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Rakati Clinic
TiberiaS, Israel
Contact: iZHAR bEN sHLOMO, md    972-52-6124781   
Sponsors and Collaborators
Meir Medical Center
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Responsible Party: Meir Medical Center Identifier: NCT02078505    
Other Study ID Numbers: PCOSGut
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014
Keywords provided by Meir Medical Center:
Change in gut microbial population
polycystic ovary syndrome
gut microbiome
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases