Eradication of Gut Microbiota (ERA)
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ClinicalTrials.gov Identifier: NCT01633762 |
Recruitment Status
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Completed
First Posted
: July 4, 2012
Last Update Posted
: December 2, 2015
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Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborators:
University of Copenhagen
Steno Diabetes Center
Department of clinical microbiology, Rigshospitalet, Copenhagen
Information provided by (Responsible Party):
Kristian Hallundbuk Mikkelsen, University Hospital, Gentofte, Copenhagen
Tracking Information | ||||
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First Submitted Date ICMJE | June 28, 2012 | |||
First Posted Date ICMJE | July 4, 2012 | |||
Last Update Posted Date | December 2, 2015 | |||
Study Start Date ICMJE | April 2012 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
changes in postprandial GLP-1 secretion [ Time Frame: 0, 4 and 42 days after antibiotic eradication of gut bacteria ] plasma level of GLP-1 at baseline and during a 4 hour-meal test
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01633762 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Eradication of Gut Microbiota | |||
Official Title ICMJE | Eradication of Gut Microbiota - Effects on Postprandial Gut Hormone Secretion, Glucose Metabolism, Bone Metabolism and Gut Microbiome | |||
Brief Summary | 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 | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Early Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE |
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Intervention ICMJE | Drug: 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) |
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Study Arms | Experimental: meropenem, gentamicin, vancomycin
Intervention: Drug: meropenem, gentamicin, vancomycin (together) |
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Publications * | Mikkelsen KH, Frost M, Bahl MI, Licht TR, Jensen US, Rosenberg J, Pedersen O, Hansen T, Rehfeld JF, Holst JJ, Vilsbøll 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
12 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | April 2013 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 40 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Denmark | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01633762 | |||
Other Study ID Numbers ICMJE | ERA 2012 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Kristian Hallundbuk Mikkelsen, University Hospital, Gentofte, Copenhagen | |||
Study Sponsor ICMJE | University Hospital, Gentofte, Copenhagen | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University Hospital, Gentofte, Copenhagen | |||
Verification Date | November 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |