Role of the Nasal Environment in Obesity

Role of the Nasal Microbiota in Obesity - the microNASA Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06153654

Enrollment

150

Registered

2023-12-01

Start date

2021-07-30

Completion date

2025-09-30

Last updated

2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adiposity

Keywords

Adiposity, Olfactory Function, Microbiome

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

* Smoking * 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)

Design outcomes

Primary

Measure	Time frame	Description
Difference in nasal microbiota composition	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

Measure	Time frame	Description
Change in nasal microbiota Composition after bariatric surgery	24 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 changes in nasal microbiome in obese patients before and 1, 3, 6 and 12 month after bariatric surgery.

Countries

Switzerland

Contacts

Primary ContactKatharina Timper, Prof. Dr. med.

katharina.timper@usb.ch+41 61 328 57 42

Backup ContactAnouk Hoogkamer

anouklisa.hoogkamer@usb.ch+41 61 328 55 20

Outcome results