AzTrials
AzTrials

DiabetesEarly Phase 1ERANCT01633762

Eradication of Gut Microbiota

A Early Phase 1 study testing meropenem, gentamicin, vancomycin (together) in people with Diabetes and Obesity, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Diabetes, Obesity, Osteoporosis
What is being tested?
meropenem, gentamicin, vancomycin (together)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteDenmark
Study dates
Apr 2012to Apr 2013
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • danish caucasian ethnicity
  • informed consent
  • normal fasting plasma glucose
  • normal HbA1c (<6 %)
  • normal serum lipids
  • normal thyroid function
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  • normal danish diet
  • non-smoking
  • normal stool habits

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Gentofte University Hospital

    Hellerup, 2900

Other trials in Denmark

About this study

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

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.

Being tested
meropenem, gentamicin, vancomycin (together)
Medical subject headings
Diabetes Mellitus, Obesity, Osteoporosis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT01633762
Study groupRoleWhat they receive
meropenem, gentamicin, vancomycinExperimentalNot described
Receives: Drug: meropenem, gentamicin, vancomycin (together)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes in postprandial GLP-1 secretion

    plasma level of GLP-1 at baseline and during a 4 hour-meal test

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

Secondary outcomes (18)

  1. changes in postprandial insulin/c-peptide secretion

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

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

  2. changes in postprandial glucose levels

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

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

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

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

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

  4. changes in markers of bone formation and resorption

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

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

  5. gut microbiome composition

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

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

  6. changes in markers of systemic inflammation

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

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

  7. changes in glycated hemoglobin (HbA1c)

    plasma level of glycated hemoblobin

    Measured: 42 days after antibiotic eradication of gut bacteria

  8. changes in body weight

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

  9. changes in basal metabolic rate and respiratory quotient

    indirect calorimetry measurements (210 minutes postprandial)

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

  10. changes in gastric emptying

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

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

  11. changes in gall bladder emptying

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

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

  12. appetite, satiety and food intake

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

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

  13. changes in ketone metabolism

    measurement of fasting plasma beta-hydroxybutyrate level

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

  14. changes in bile acid deconjugation

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

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

  15. changes in plasma lipid levels

    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)

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

  16. microbiome in blood, urine and saliva

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

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

  17. adverse effects of the used antibiotics

    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.

    Measured: up to 180 days after antibiotic eradication of gut bacteria

  18. changes in metabolomic profile

    plasma and urine samples for metabolomic analysis

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01633762
Sponsor's protocol ID
ERA 2012
Acronym
ERA
Status last verified
Nov 2015
First submitted
28 Jun 2012
Last updated
2 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Mikkelsen KH, Frost M, Bahl MI, Licht TR, Jensen US, Rosenberg J, Pedersen O, Hansen T, Rehfeld JF, Holst JJ, Vilsboll 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.

    PubMed 26562532

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing meropenem, gentamicin, vancomycin (together) in people with Diabetes and Obesity, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes in postprandial GLP-1 secretion (time frame: 0, 4 and 42 days after antibiotic eradication of gut bacteria). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01633762, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015; AzTrials last refreshed its copy on 30 Oct 2026.

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