Eradication of Gut Microbiota (ERA)

November 30, 2015 updated by: Kristian Hallundbuk Mikkelsen, University Hospital, Gentofte, Copenhagen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Gentofte University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: meropenem, gentamicin, vancomycin
Drug: meropenem, gentamicin, vancomycin (together)
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
0, 4 and 42 days after antibiotic eradication of gut bacteria

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
0, 4 and 42 days after antibiotic eradication of gut bacteria
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
0, 4 and 42 days after antibiotic eradication of gut bacteria
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
0, 4 and 42 days after antibiotic eradication of gut bacteria
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
0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria
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
0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria
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
0, 4, 42 and 180 days after antibiotic eradication of gut bacteria
changes in glycated hemoglobin (HbA1c)
Time Frame: 42 days after antibiotic eradication of gut bacteria
plasma level of glycated hemoblobin
42 days after antibiotic eradication of gut bacteria
changes in body weight
Time Frame: 0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria
0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria
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)
0, 4 and 42 days after antibiotic eradication of gut bacteria
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
0, 4 and 42 days after antibiotic eradication of gut bacteria
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)
0, 4 and 42 days after antibiotic eradication of gut bacteria
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
0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria
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
0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria
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
0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria
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)
0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria
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
0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria
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.
up to 180 days after antibiotic eradication of gut bacteria
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
0, 4, 8, 42 and 180 days after antibiotic eradication of gut bacteria

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Gentofte, Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
Steno Diabetes Center Copenhagen
Department of clinical microbiology, Rigshospitalet, Copenhagen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kristian H Mikkelsen, MD, Diabetes Research Unit, Gentofte Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ERA 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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