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Clinical Trials/NCT06153654
NCT06153654RecruitingNot Applicable

Role of the Nasal Microbiota in Obesity - the microNASA Study

Katharina Timper1 site in 1 country150 target enrollmentStarted: July 30, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
Difference in nasal microbiota composition
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The primary aim of this study is to investigate the nasal environment in obese and lean individuals.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •N=50 adult male and female patients with obesity will be included in this study.
  • •Inclusion criteria:
  • •Inclusion criteria:
  • •Age 18-55 years
  • •Written informed consent
  • •BMI > 30 kg/m2
  • •N=50 adult lean patients age- and sex-matched to the group of obese patients will be included in this study.
  • •Inclusion criteria:
  • •Age 18-55 years
  • •Written informed consent
  • •BMI 18-25 kg/m2
  • •N=50 adult male and female patients with obesity with scheduled bariatric will be included in this study
  • •Inclusion criteria:
  • •Age 18-55 years
  • •Written informed consent
  • •BMI > 35 kg/m2

Exclusion Criteria

  • •Chronic or acute sinusitis
  • •Surgical intervention of the nasal cavity or the paranasal sinus
  • •Use of antibiotics within the last 31 days18
  • •Current illicit drug abuse including daily marijuana or CBD consumption (≤ 24 g of alcohol per day allowed)
  • •Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
  • •Use of any kind of decongestant more than twice a week
  • •Use of cortisone-containing nasal spray within the last 3 months
  • •Acute allergic rhinitis
  • •History of neurodegenerative diseases
  • •History of severe head trauma
  • •Severe renal impairment (e.g. estimated glomerular filtration rate <30 ml/min/m2)

Outcomes

Primary Outcomes

Difference in nasal microbiota composition

Time Frame: 6 Months

The microbiome of the nasal cavity will be analyzed by isolating DNA from Nasal Swabs through amplicon sequencing. We will define the primary endpoint as the difference in nasal microbiome in obese vs. sex- and age-matched lean control individuals.

Secondary Outcomes

  • Change in nasal microbiota Composition after bariatric surgery(24 Months)

Investigators

Sponsor
Katharina Timper
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Katharina Timper

Prof. Dr. med.

University Hospital, Basel, Switzerland

Study Sites (1)

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