The Relationship of the Intestinal Microbiome and the Menstrual Cycle
NCT ID: NCT03581201
Last Updated: 2019-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2018-07-18
2020-07-01
Brief Summary
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Detailed Description
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The composition of a healthy microbiome consists more than 90% of bacteria from the Bacteroidetes and Firmicutes phyla types. Nevertheless the microbiome varies even between healthy individuals and evolves over the lifetime.
Most of the microorganisms are not pathogen, thus they have been shown to interact with several physiological processes in our body. In Addition it has been shown that the bacterial population has an impact on building our gut epithelial cells, our immunology and the defence against pathogens.
Interestingly estrogen and the microbiome seem to be under reciprocal influence. In our body estrogen is only active in the deconjugated form. Therefore, after it was conjugated in the liver, the bacteria in the gut can perform a deconjugation through the secretion of the enzyme ß-glucuronidase. Ultimately, the activated estrogen is going back into blood circulation, otherwise it would leave the body through bile excretion. The composition of the microbiome is fundamental, because the presence and abundance of different gene expressions varies between the different types of bacteria. The bacterial genes which are responsible for metabolizing estrogens are called the estrobolome. However, data whether there is a relationship of the changes of the sex hormones during the menstrual cycle and the intestinal microbiome in women is sparse.
Parts of the estrogens circulating in the body are metabolised in the liver and are then secreted to the intestine conjugated with glucuronide. The intestinal microbiota could potentially affect estrogen metabolism via Beta-glucuronidase activity. Beta-glucuronidase is an enzyme that catalyses the deconjugation of estrogen. As a consequence, it may bind to estrogen receptors and unfold its downstream effects.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Oral contraception
Healthy females at childbearing age with oral contraception.
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
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.
Bioimpedance analysis
The Bioimpedance analysis (BIA) is used for the measurement of body composition and will be done at every study visit.
No contraception
Healthy females without any contraception at all.
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
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.
Bioimpedance analysis
The Bioimpedance analysis (BIA) is used for the measurement of body composition and will be done at every study visit.
Interventions
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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
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.
Bioimpedance analysis
The Bioimpedance analysis (BIA) is used for the measurement of body composition and will be done at every study visit.
Eligibility Criteria
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Inclusion Criteria
* age 18-40 years
* BMI 18.5-24.9 kg/m²
* taking oral contraceptives
* not having any contraceptives
Exclusion Criteria
* history of taking antibiotics or probiotics in the last 3 months
* gastrointestinal disorders in the last 3 months
* Polycystic Ovary Syndrome
* disorders of the menstrual cycle (e.g. oligomenorrhea, anovulation)
* other than mediterranean diet
18 Years
40 Years
FEMALE
Yes
Sponsors
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University of Vienna
OTHER
Medical University of Vienna
OTHER
Responsible Party
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Alexandra Kautzky-Willer
Univ. Prof. Dr., Head of the Gender Medicine Unit
Principal Investigators
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Alexandra Kautzky-Willer, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MB2018
Identifier Type: -
Identifier Source: org_study_id
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