NCT02078505

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

1.9 years

First QC Date

March 3, 2014

Last Update Submit

March 10, 2014

Conditions

Polycystic Ovary Syndrome

Keywords

Change in gut microbial populationpolycystic ovary syndromegut microbiomediet

Outcome Measures

Primary Outcomes (1)

  • change in microbial population of the colon

    2 months of diet

Study Arms (2)

PCOS after diet

EXPERIMENTAL

Patients after 2 months of diet

Behavioral: diet

control

NO INTERVENTION

Ovulatory women

Interventions

dietBEHAVIORAL

Carbohydrate poor diet

PCOS after diet

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Study group - no other etiologies for infertility

You may not qualify if:

  • Other etiologies for infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rakati Clinic

Tiberias, Israel

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Diet

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Izhar Ben Shlomo, MD

CONTACT

972-52-6124781izhar.benshlomo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 5, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations

IL(1)