Effects of glucocorticoids on human gut bacteria

Studies of interplays between insulin resistance associated with immunosuppression and the gut and saliva microbiota composition of young, healthy men - GEMP

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001850-16-DK

Enrollment

Unknown

Registered

2016-05-24

Start date

2016-06-28

Completion date

Unknown

Last updated

2017-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Young healthy men MedDRA version: 20.0 Level: PT Classification code 10062026 Term: Investigation System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Prednisolon "DLF" Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE Concentration unit: mg milligram(s) Concentration type: range Concentr

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Male - Age 18-35 years, both inclusive - 18.5 kg/m2 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Denmark

Contacts

Public ContactOluf Borbye Pedersen

University of Copenhagen, The Novo Nordisk Foundation Center For Basic Metabolic Research, Section of Metabolic Genetic

oluf@sund.ku.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026