E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Young healthy men |
Unge raske mænd |
|
E.1.1.1 | Medical condition in easily understood language |
Young healthy men |
Unge raske mænd |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062026 |
E.1.2 | Term | Investigation |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Examine structural changes in gut microbiota before, during and after glucocorticoid treatmet. |
Undersøge strukturelle ændringer i tarmmikrobiomet før, under og efter glukokortikoidbehandling. |
|
E.2.2 | Secondary objectives of the trial |
Investigate changes in metabolic markers in urine, saliva, blood, serum and fecal samples following glucocorticoid treatment. |
Undersøge ændringen i forskellige biologiske markører målt i urin, spyt, blod, serum og afføring efter glukokortikoidbehandling. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
- Mand - Alder mellem 18-35, begge inklusive - BMI mellem 18,5 og 27 kg/m2 - Vægtstabil, defineret ved ikke at have haft et vægttab eller en vægtøgning på mere end 3kg, indenfor de sidste 3 måneder af screeningsdagen. - Normalt blodsukker, bedømt ud fra den gennemsnitlige blodsukkerkoncentration målt ved HbA1c der skal være mindre end 39mmol/mol - Normal nyrefunktion, bedømt ud fra nyretallet kreatinin, justeret for alder. - Normal leverfunktion, bedømt ud fra leverenzymet ALAT der skal være mellem 10 og 70 IU/L. - Normalt blodtryk. Systolisk blodtryk under 140mmHg og diastolisk blodtryk under 90mmHg. |
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E.4 | Principal 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 |
- Rygning på daglig basis - Brug af lægeordineret medicin indenfor de sidste 4 måneder af screeningsdagen. - Daglig brug af probiotika. - Bevidste ændringer i kost eller motionsvaner indenfor de sidste 2 måneder af screeningsdagen. - Kronisk eller akut (akut: indenfor de sidste 2 måneder af screeningsdagen) sygdom. - Tidligere operation i maveregionen, fraset ukompliceret blindtarmsbetændelse. - Tidligere mentale lidelser. - Ikke i stand til at give informeret samtykke. - Behov for medicinsk behandling i løbet af forsøget. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Structural change of gut microbiota during and after glucocorticoid treatment. |
Strukturelle ændringer i tarmmikrobiomet under og efter glukokortikoidbehandling. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Changes in metabolic markers in urine, saliva, blood, serum and fecal samples during and after glucocorticoid treatment. |
Ændringer i forskellige biologiske markører målt i urin, spyt, blod,serum og afføring under og efter glukokortikoidbehandling. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Implications of glucocorticoid treatment on human gut microbiota and related physiological changes. |
Følger af glukokortikoidbehandling i det humane tarmmikrobiom og relaterede fysiologiske ændringer. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Clinical trial investigating the effect of glucocorticoids on the gut microbiota |
Klinisk forsøg der undersøger effekten af glukokortikoider på tarmens mikrobiota |
|
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |