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The Relationship of the Intestinal Microbiome and the Menstrual Cycle

NCT03581201 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2019-09-03

No results posted yet for this study

Summary

In the present study the dynamic changes of the intestinal microbiome are observed over a 4-week period in the different stages of the menstrual cycle in women at childbearing age. The focus is on how the dynamic changes of sex hormones during a menstrual cycle of women at childbearing age (with or without contraception) are related to microbiological colonization of the gut. In Addition the Expression of the β-glucuronidase by the bacteria will be investigated.

Conditions

  • Sex Hormones
  • Microbial Colonization

Interventions

DIAGNOSTIC_TEST

Laboratory measurements

Laboratory measurements will be collected every week during the Duration of one menstrual cycle and includes the following: * Hormone analysis * Clinical chemistry * Complete blood count * Adipokines * Glucose and HbA1c-levels * Urinary Chemistry

DIAGNOSTIC_TEST

Stool samples

For a Duration of one menstrual cycle the study participants will be instructed to collect stool samples every two days. The investigation of the intestinal microbiome will be done by sequencing the 16S rRNA gene.

DIAGNOSTIC_TEST

Bioimpedance analysis

The Bioimpedance analysis (BIA) is used for the measurement of body composition and will be done at every study visit.

Sponsors & Collaborators

  • University of Vienna

    collaborator OTHER

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Alexandra Kautzky-Willer, Prof. Dr. · Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2020-06-13
Completion
2020-07-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03581201 on ClinicalTrials.gov