Skip to main content
OpenTrials
Completed

NCT Number: NCT01633762

Eradication of Gut Microbiota

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Body Weight Bone Diseases Bone Diseases, Metabolic Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteoporosis Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Gentofte University Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

meropenem, gentamicin, vancomycin (together)

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. changes in postprandial insulin/c-peptide secretion

    Time frame: 0, 4 and 42 days after antibiotic eradication of gut bacteria

    plasma level of insulin/C-peptide at baseline and during a 4 hour-meal test

  2. changes in postprandial glucose levels

    Time frame: 0, 4 and 42 days after antibiotic eradication of gut bacteria

    plasma level of glucose at baseline and during a 4 hour-meal test

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

    Time frame: 0, 4 and 42 days after antibiotic eradication of gut bacteria

    plasma levels of GLP-2, glucagon, PYY, oxyntomodulin, gastrin, CCK, GIP, leptin, adiponectin and ghrelin at baseline and during a 4 hour-meal test

  4. changes in markers of bone formation and resorption

    Time frame: 0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria

    fasting plasma levels of osteocalcin, P1NP, CTX, 1CTP, sklerostin and serotonin

  5. gut microbiome composition

    Time frame: 0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria

    faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in feces

  6. changes in markers of systemic inflammation

    Time frame: 0, 4, 42 and 180 days after antibiotic eradication of gut bacteria

    plasma levels of high sensitive CRP, LPBP, TNF-alfa, IL-6 and PAI

  7. changes in glycated hemoglobin (HbA1c)

    Time frame: 42 days after antibiotic eradication of gut bacteria

    plasma level of glycated hemoblobin

  8. changes in body weight

    Time frame: 0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria

  9. changes in basal metabolic rate and respiratory quotient

    Time frame: 0, 4 and 42 days after antibiotic eradication of gut bacteria

    indirect calorimetry measurements (210 minutes postprandial)

  10. changes in gastric emptying

    Time frame: 0, 4 and 42 days after antibiotic eradication of gut bacteria

    1,5 grams of paracetamol will be added to a standardized meal, plasma paracetamol will be measured at baseline and succeeding 4 hours postprandial

  11. changes in gall bladder emptying

    Time frame: 0, 4 and 42 days after antibiotic eradication of gut bacteria

    ultrasonic determination of gall bladder dimensions at baseline and during a 4 hour-meal test (expressed as gall bladder ejection fraction)

  12. appetite, satiety and food intake

    Time frame: 0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria

    the impact of eradication on alimentary processes and appetite regulation will be measured using questionnaires and food intake measures

  13. changes in ketone metabolism

    Time frame: 0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria

    measurement of fasting plasma beta-hydroxybutyrate level

  14. changes in bile acid deconjugation

    Time frame: 0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria

    measurement of feces bile acid (conjugated and deconjugated) concentration to study the effect of gut microbiome presence on bile acid deconjugation

  15. changes in plasma lipid levels

    Time frame: 0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria

    fasting plasma levels of triglyceride, VLDL, LDL, HDL, total cholesterol, in addition: measurements of free fatty acids during a 4 hour meal 0, 4 and 42 days after eradication (not on day 8 and 180)

  16. microbiome in blood, urine and saliva

    Time frame: 0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria

    measurements on bacteria or bacterial components in blood, urine and saliva to study the effects of gut eradication on blood, urine and saliva microbiome

  17. adverse effects of the used antibiotics

    Time frame: up to 180 days after antibiotic eradication of gut bacteria

    standardized questionaries regarding gastointestinal function are filled out at each study visit (0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria) to detect possible adverse effects of antibiotics. In addition, subjects are given a calendar and informed to write down any symptom or illness during the study period.

  18. changes in metabolomic profile

    Time frame: 0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria

    plasma and urine samples for metabolomic analysis

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • Rigshospitalet, Denmark
  • Steno Diabetes Center Copenhagen
  • University of Copenhagen

Registry information

Official study title

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

Acronym: ERA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 4, 2012
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.