The Relationship of the Intestinal Microbiome and the Menstrual Cycle

NCT ID: NCT03581201

Last Updated: 2019-09-03

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-18

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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Our gut has a complex and diverse bacterial population which is called the microbiome. The number of bacteria in the intestine is estimated to exceed 10\^14. The composition of the microbiome is individual and changes over the lifetime of the host.

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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Sex Hormones Microbial Colonization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral contraception

Healthy females at childbearing age with oral contraception.

Laboratory measurements

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Bioimpedance analysis

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* women at childbearing age
* age 18-40 years
* BMI 18.5-24.9 kg/m²
* taking oral contraceptives
* not having any contraceptives

Exclusion Criteria

* chronic and acute infectious diseases
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Vienna

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Kautzky-Willer

Univ. Prof. Dr., Head of the Gender Medicine Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Alexandra Kautzky-Willer, Prof. Dr.

Role: CONTACT

+434040021260

Michael Leutner, Dr.med.univ., PhD, MSc

Role: CONTACT

Facility Contacts

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Alexandra Kautzky-Willer, Univ.Prof.Dr.

Role: primary

+434040021260

Other Identifiers

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MB2018

Identifier Type: -

Identifier Source: org_study_id

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