Sex HormonesNCT03581201
The Relationship of the Intestinal Microbiome and the Menstrual Cycle
An observational study of Sex Hormones and Microbial Colonization, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sex Hormones, Microbial Colonization
- What is being tested?
- Laboratory measurements, Stool samples and Bioimpedance analysis
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 18 Jul 2018to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: In total, 20 patients (10 subjects with oral contraceptives and 10 subjects without oral contraceptives or any contraceptive at all) between 18 and 40 years and a body mass index (BMI) between 18 and 24 kg/ m² will be examined in this study.
Who may be able to join
- women at childbearing age
- age 18-40 years
- BMI 18.5-24.9 kg/m²
- taking oral contraceptives
- not having any contraceptives
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Michael Leutner, Dr.med.univ., PhD, MSc contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Alexandra Kautzky-Willer, Univ.Prof.Dr., +434040021260, alexandra.kautzky-willer@meduniwien.ac.at
About this study
Official title: The Relationship of the Intestinal Microbiome and the Dynamic Changes of Sex Hormone Concentrations in Women at Childbearing Age
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.
Read the detailed description
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
- Sex Hormones, Microbial Colonization
- Being tested
- Laboratory measurements, Stool samples, Bioimpedance analysis
- Keywords
- intestinal microbiome, oral contraceptives, estrogens, bacterial population, hormone status, glucose profiles, lipid parameters, body composition
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory measurementsDiagnostic 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 samplesDiagnostic 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 analysisDiagnostic test
The Bioimpedance analysis (BIA) is used for the measurement of body composition and will be done at every study visit.
| Study group | Role | What they receive |
|---|---|---|
| Oral contraception | Healthy females at childbearing age with oral contraception. Receives: Diagnostic Test: Laboratory measurements; Diagnostic Test: Stool samples; Diagnostic Test: Bioimpedance analysis | |
| No contraception | Healthy females without any contraception at all. Receives: Diagnostic Test: Laboratory measurements; Diagnostic Test: Stool samples; Diagnostic Test: Bioimpedance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the B-Glucuronidase, expressed by the intestinal microbiome, during the menstrual cycle in women at childbearing age
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 β-glucuronidase activity. β-glucuronidase is an enzyme that catalyses the deconjugation of estrogen. As a consequence, it may bind to estrogen receptors and unfold its downstream effects.
RNA and total DNA will be extracted from the fecal samples and microbiome community composition will be assessed by sequencing the 16s ribosomal RNA gene. Then reverse transcription of the total RNA and targeted amplification and sequencing of β-glucuronidase gene fragment will be applied in order to find out which bacteria are producing the β-glucuronidase enzyme.
Furthermore, the enzymatic activity in the samples will be measured using the β-glucuronidase colorimetric assay with p-nitrophenol glucuronide.
Measured: Up to 7 weeks
Secondary outcomes (5)
Changes of the Beta-Glucuronidase during the menstrual cycle in women with oral contraception
Measured: Up to 7 weeks
Changes of the Beta-Glucuronidase during the menstrual cycle in women without any contraception
Measured: Up to 7 weeks
Changes of the intestinal microbiome during the menstrual cycle in women at childbearing age with- and without contraception
Measured: Up to 7 weeks
Relationship of the β-Glucuronidase with the changes of the female sex hormones during the menstrual cycle in women at childbearing age.
Measured: Up to 7 weeks
Relationship of the intestinal microbiome with the changes of the female sex hormones during the menstrual cycle in women at childbearing age.
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start18 Jul 2018
- Primary completion13 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sex HormonesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna
- Responsible party
- Principal investigator, Alexandra Kautzky-Willer, Medical University of Vienna
- Investigators
- Alexandra Kautzky-Willer, Prof. Dr., Principal investigator, Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581201
- Sponsor's protocol ID
- MB2018
- Status last verified
- Aug 2019
- First submitted
- 10 Jun 2018
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of the Intestinal Microbiome and the Dynamic Changes of Sex Hormone Concentrations in Women at Childbearing Age
- ClinicalTrials.gov ID
- NCT03581201
- Acronym / sponsor ID
- MB2018
- Conditions
- Sex Hormones, Microbial Colonization
- Keywords
- intestinal microbiome, oral contraceptives, estrogens, bacterial population, hormone status, glucose profiles, lipid parameters, body composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University of Vienna
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 13 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral contraception | – | Diagnostic Test: Laboratory measurements, Diagnostic Test: Stool samples, Diagnostic Test: Bioimpedance analysisHealthy females at childbearing age with oral contraception. |
| No contraception | – | Diagnostic Test: Laboratory measurements, Diagnostic Test: Stool samples, Diagnostic Test: Bioimpedance analysisHealthy females without any contraception at all. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In total, 20 patients (10 subjects with oral contraceptives and 10 subjects without oral contraceptives or any contraceptive at all) between 18 and 40 years and a body mass index (BMI) between 18 and 24 kg/ m² will be examined in this study.
Key inclusion criteria (5 listed)
- women at childbearing age
- age 18-40 years
- BMI 18.5-24.9 kg/m²
- taking oral contraceptives
- not having any contraceptives
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory measurementsLaboratory 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 | No contraception, Oral contraception |
| Stool samplesFor 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 | No contraception, Oral contraception |
| Bioimpedance analysisThe Bioimpedance analysis (BIA) is used for the measurement of body composition and will be done at every study visit. | Diagnostic test | No contraception, Oral contraception |
Primary outcome
Changes of the B-Glucuronidase, expressed by the intestinal microbiome, during the menstrual cycle in women at childbearing age
Time frame: Up to 7 weeks
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 β-glucuronidase activity. β-glucuronidase is an enzyme that catalyses the deconjugation of estrogen. As a consequence, it may bind to estrogen receptors and unfold its downstream effects. RNA and total DNA will be extracted from the fecal samples and microbiome community composition will be assessed by sequencing the 16s ribosomal RNA gene. Then reverse transcription of the total RNA and targeted amplification and sequencing of β-glucuronidase gene fragment will be applied in order to find out which bacteria are producing the β-glucuronidase enzyme. Furthermore, the enzymatic activity in the samples will be measured using the β-glucuronidase colorimetric assay with p-nitrophenol glucuronide.
5 secondary outcomes
Changes of the Beta-Glucuronidase during the menstrual cycle in women with oral contraception
Time frame: Up to 7 weeks
Changes of the Beta-Glucuronidase during the menstrual cycle in women without any contraception
Time frame: Up to 7 weeks
Changes of the intestinal microbiome during the menstrual cycle in women at childbearing age with- and without contraception
Time frame: Up to 7 weeks
Relationship of the β-Glucuronidase with the changes of the female sex hormones during the menstrual cycle in women at childbearing age.
Time frame: Up to 7 weeks
Relationship of the intestinal microbiome with the changes of the female sex hormones during the menstrual cycle in women at childbearing age.
Time frame: Up to 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Leutner, Dr.med.univ., PhD, MSc contact
Alexandra Kautzky-Willer, Prof. Dr. principal investigator
Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sex Hormones and Microbial Colonization, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Kautzky-Willer, Prof. Dr. (+434040021260, alexandra.kautzky-willer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the B-Glucuronidase, expressed by the intestinal microbiome, during the menstrual cycle in women at childbearing age (time frame: Up to 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.