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Eradication of Gut Microbiota

NCT ID: NCT01633762

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-04-30

Brief Summary

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The aim of the study is to assess the effect of eradication of gut microbiota on 1) glucose metabolism including postprandial plasma responses of the incretin hormones GIP and GLP-1, insulin, C-peptide and glucagon, 2) metabolomic profiles and resting energy expenditure (REE) 3) appetite, satiety, food intake, gastric emptying and gall bladder emptying, 4) levels of markers of bone formation and resorption as well as serotonin, 5) markers of systemic inflammation, and 6) on the (prospective) composition of bacteria in faeces, blood and saliva. Thus, the overall objective is to provide detailed knowledge on the physiological role of gut microbiota combined with bioinformatic analyses of the functional implications of changes in bacteria composition on the level of both species and phylum.

Detailed Description

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Conditions

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Diabetes Obesity Osteoporosis Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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meropenem, gentamicin, vancomycin

Group Type EXPERIMENTAL

meropenem, gentamicin, vancomycin (together)

Intervention Type DRUG

4 days antibiotic treatment, per oral, once daily: vancomycin 500 mg (Vancomycin "Hospira"), powder for concentrate; gentamycin 40 mg ("Hexamycin®"), solution; meropenem 500 mg (Meropenem "Hospira"), powder for concentrate; The three drugs are dissolved and combined to a cocktail (with approximately 100 ml of apple juice)

Interventions

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meropenem, gentamicin, vancomycin (together)

4 days antibiotic treatment, per oral, once daily: vancomycin 500 mg (Vancomycin "Hospira"), powder for concentrate; gentamycin 40 mg ("Hexamycin®"), solution; meropenem 500 mg (Meropenem "Hospira"), powder for concentrate; The three drugs are dissolved and combined to a cocktail (with approximately 100 ml of apple juice)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* danish caucasian ethnicity
* informed consent
* normal fasting plasma glucose
* normal HbA1c (\<6 %)
* normal serum lipids
* normal thyroid function
* normal danish diet
* non-smoking
* normal stool habits

Exclusion Criteria

* known bone disease
* liver disease (ALAT or ASAT \>2 upper normal value)
* kidney disease (serum creatinine \>130 μM)
* anaemia
* BMI \<18.5 kg/m2 or BMI \>25 kg/m2
* known gastrointestinal disease (including prior bariatric surgery,lactose -intolerance, celiac disease, inflammatory bowel disease) or known familial disposition for lactose intolerance, celiac disease, inflammatory bowel disease
* antibiotic treatment within 6 months prior to study including malaria prophylaxis
* medication which cannot be on hold for the study period
* contraindications against/allergy towards the used antibiotics (including prior allergic reactions related to beta-lactam antibiotics, aminoglycosides or vancomycin)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role collaborator

Department of clinical microbiology, Rigshospitalet, Copenhagen

UNKNOWN

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Kristian Hallundbuk Mikkelsen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristian H Mikkelsen, MD

Role: STUDY_DIRECTOR

Diabetes Research Unit, Gentofte Hospital

Locations

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Gentofte University Hospital

Hellerup, , Denmark

Site Status

Countries

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Denmark

References

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Mikkelsen KH, Frost M, Bahl MI, Licht TR, Jensen US, Rosenberg J, Pedersen O, Hansen T, Rehfeld JF, Holst JJ, Vilsboll T, Knop FK. Effect of Antibiotics on Gut Microbiota, Gut Hormones and Glucose Metabolism. PLoS One. 2015 Nov 12;10(11):e0142352. doi: 10.1371/journal.pone.0142352. eCollection 2015.

Reference Type DERIVED
PMID: 26562532 (View on PubMed)

Other Identifiers

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ERA 2012

Identifier Type: -

Identifier Source: org_study_id