Eradication of Gut Microbiota (ERA)

University Hospital, Gentofte, Copenhagen

Status and phase

Completed

Early Phase 1

Conditions

Osteoporosis

Inflammation

Diabetes

Obesity

Treatments

Drug: meropenem, gentamicin, vancomycin (together)

Study type

Interventional

Funder types

Other

Identifiers

NCT01633762

ERA 2012

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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)