Role of the Nasal Environment in Obesity

Adiposity Clinical Trial

Official title:

Role of the Nasal Microbiota in Obesity - the microNASA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153654
• Other study ID #: 2021-01090
• Status: Recruiting
• Start date: July 30, 2021
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Katharina Timper, Prof. Dr. med.
• Phone: +41 61 328 57 42
• Email: katharina.timper[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2025
• Est. primary completion date: July 2025
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adiposity
• Obesity

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Katharina Timper

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in nasal microbiota composition	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.	6 Months
Secondary	Change in nasal microbiota Composition after bariatric surgery	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.	24 Months