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Eradication of Gut Microbiota

Information source: University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes; Obesity; Osteoporosis; Inflammation

Intervention: meropenem, gentamicin, vancomycin (together) (Drug)

Phase: Phase 0

Status: Active, not recruiting

Sponsored by: University Hospital, Gentofte, Copenhagen

Official(s) and/or principal investigator(s):
Kristian H Mikkelsen, MD, Study Director, Affiliation: Diabetes Research Unit, Gentofte Hospital

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.

Clinical Details

Official title: Eradication of Gut Microbiota - Effects on Postprandial Gut Hormone Secretion, Glucose Metabolism, Bone Metabolism and Gut Microbiome

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: changes in postprandial GLP-1 secretion

Secondary outcome:

changes in postprandial insulin/c-peptide secretion

changes in postprandial glucose levels

changes in postprandial GLP-2, glucagon, PYY, oxyntomodulin, gastrin, CCK, GIP, leptin, adiponectin and ghrelin secretion

changes in markers of bone formation and resorption

gut microbiome composition

changes in markers of systemic inflammation

changes in glycated hemoglobin (HbA1c)

changes in body weight

changes in basal metabolic rate and respiratory quotient

changes in gastric emptying

changes in gall bladder emptying

appetite, satiety and food intake

changes in ketone metabolism

changes in bile acid deconjugation

changes in plasma lipid levels

microbiome in blood, urine and saliva

adverse effects of the used antibiotics

changes in metabolomic profile

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Male.

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)

Locations and Contacts

Gentofte University Hospital, Hellerup 2900, Denmark
Additional Information

Starting date: April 2012
Last updated: July 1, 2013

Page last updated: August 23, 2015

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