Eradication of Gut Microbiota

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborators: Department of clinical microbiology, Rigshospitalet, Copenhagen; Steno Diabetes Center; Steno Diabetes Center Copenhagen; University of Copenhagen
• Treatments: Gentamicins; Meropenem; Vancomycin

Criteria

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)