The Relationship of the Intestinal Microbiome and the Menstrual Cycle

NCT03581201 | Unknown

• 1 other identifier: MB2018
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intestinal microbiome; oral contraceptives; estrogens; bacterial population; hormone status; glucose profiles; lipid parameters; body composition

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 7 weeks

Secondary Outcomes (5)

• Changes of the Beta-Glucuronidase during the menstrual cycle in women with oral contraception

  Up to 7 weeks

• Changes of the Beta-Glucuronidase during the menstrual cycle in women without any contraception

  Up to 7 weeks

• Changes of the intestinal microbiome during the menstrual cycle in women at childbearing age with- and without contraception

  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.

  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.

  Up to 7 weeks

Study Arms (2)

Oral contraception

Healthy females at childbearing age with oral contraception.

Diagnostic Test: Laboratory measurements; Diagnostic Test: Stool samples; Diagnostic Test: Bioimpedance analysis

No contraception

Healthy females without any contraception at all.

Diagnostic Test: Laboratory measurements; Diagnostic Test: Stool samples; Diagnostic Test: Bioimpedance analysis

Interventions

Laboratory measurements 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

No contraception; Oral contraception

Stool samples 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.

No contraception; Oral contraception

Bioimpedance analysis DIAGNOSTIC_TEST

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

No contraception; Oral contraception

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• University of Vienna: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra Kautzky-Willer, Prof. Dr.

  Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Kautzky-Willer, Prof. Dr.

CONTACT

+434040021260; alexandra.kautzky-willer@meduniwien.ac.at

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

CONTACT

michael.leutner@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr., Head of the Gender Medicine Unit

Study Record Dates

• First Submitted: June 10, 2018
• First Posted: July 10, 2018
• Study Start: July 18, 2018
• Primary Completion: June 13, 2020
• Study Completion: July 1, 2020
• Last Updated: September 3, 2019

Record last verified: 2019-08

Locations

AU (1)