Effects of glucocorticoids on human gut bacteria

Phase 1

• Conditions: Young healthy men; MedDRA version: 20.0Level: PTClassification code 10062026Term: InvestigationSystem Organ Class: 10022891 - Investigations; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2016-001850-16-DK
• Lead Sponsor: niversity of Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, Section of Metabolic Genetic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-24
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

-Male
-Age 18-35 years, both inclusive
-18.5 kg/m2 < Body Mass Index (BMI) < 27.0 kg/m2
-Weight stable, defined by no history of loss or gain of more than 3kg, two months prior to
recruitment
-Normal glucose metabolism evaluated at the time of screening by Glycosylated Hemoglobin, Type A1c (HbA1c) < 39mmol/mol
-Normal kidney functions as evaluated by normal plasma creatinine levels adjusted for age
-Normal liver function as evaluated by plasma Alanine Amino Transferase (ALAT) 10-70 IU/L
-Normal blood pressure measured with a calibrated automated sphygmomanometer. Systolic pressure < 140mmHg and diastolic pressure < 90mmHg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Smoking on daily basis
-Oral intake of any form of prescribed medication four months prior to recruitment
-Daily use of probiotics four months prior to recruitment
-Deliberate changes in diet two months prior to recruitment
-Chronic or acute (the latter within the recent two months) illness of any type
-Previous gastrointestinal operation, disregarding uncomplicated appendicitis
-Previous mental disorders
-Unable to give informed consent
-Need of medical treatment during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Examine structural changes in gut microbiota before, during and after glucocorticoid treatmet.;Secondary Objective: Investigate changes in metabolic markers in urine, saliva, blood, serum and fecal samples following glucocorticoid treatment.;Primary end point(s): Structural change of gut microbiota during and after glucocorticoid treatment. ;Timepoint(s) of evaluation of this end point: Spring 2017

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in metabolic markers in urine, saliva, blood, serum and fecal samples during and after glucocorticoid treatment.;Timepoint(s) of evaluation of this end point: Fall 2017