Variations in the Composition of Respiratory Microbiota

NCT04747184 | Completed

• 1 other identifier: 1800164
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Induced sputum samples were obtained from 27 asthmatic patients and 27 non-asthmatic subjects. Sequencing of the V4 region of 16S rRNA gene using Illumina MiSeq was performed, followed by analysis of alpha and beta diversity.

Conditions

Asthma

Keywords

Asthma; Respiratory microbiota; Haemophilus influenzae; Oral corticosteroids; Inhalers

Outcome Measures

Primary Outcomes (1)

• To identify the common microorganisms in the LRT among asthmatic patients and non-asthmatic subjects in Jordan

  To asses the microbiome in the LRS between asthmatic patients and non-asthmatic by sequencing the 16s rRNA gene from the collected samples, after extracting the DNA

  10 months

Secondary Outcomes (1)

• To identify a common microbial bioindicator that could be used as a diagnostic tool

  10 months

Study Arms (2)

Asthmatic patients

Asthmatic patients aged 14-year-old, and more were included in the study. Knowing that patient with the age of 14-year is treated as adults at Al Bashir Hospital. Smokers, patients reported to have taken antibiotics for at least two months before study enrolment, and patients who had other respiratory diseases or infections were excluded from the study.

Other: DNA extraction and 16S rRNA sequencing

Healthy subjects

Healthy subjects aged 14-year-old, and more were included in the study. Smokers, patients reported to have taken antibiotics for at least two months before study enrolment, and patients who had other respiratory diseases or infections were excluded from the study.

Other: DNA extraction and 16S rRNA sequencing

Interventions

DNA extraction and 16S rRNA sequencing OTHER

DNA extraction using QIAamp® DNA mini kit (QIAGEN) was done under aseptic techniques in the sterile room for all samples according to the manufacturer instructions. The DNA extracts for the 54 samples collected (27 from asthmatic patients and 27 from healthy subjects) were stored at -80° C in a sterile Eppendorf tubes until they were sent to the Molecular Research (MR DNA) Lab (Molecular Research LP, Shallowater, TX, USA) for sequencing.

Asthmatic patients; Healthy subjects

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asthmatic, non-smoker, aged 14 years-old living in Jordan

You may qualify if:

• Asthmatic patients
• healthy subjects
• aged 14-year-old

You may not qualify if:

• Smokers
• patients reported having taken antibiotics for at least two months before study enrolment 3- patients who had other respiratory diseases or infections.

Sponsors & Collaborators

• Applied Science Private University: lead

Study Sites (1)

Applied Science private University

Amman, 11931, Jordan

Location

Biospecimen

Retention: SAMPLES WITH DNA

All participants were asked to expectorate a sputum sample in special sterile tubes indicated for sputum collection. Particular care was taken to avoid contamination of the sputum sample with the saliva and post-nasal drip by asking the participants to rinse their mouth with sterile water before inducing the sputum sample. Then the expectorated sputum specimen was immediately homogenized and stored in the deep freezer (-80°C) for DNA extraction for microbial gene sequencing and sequence analysis.

MeSH Terms

Conditions

Asthma; Haemophilus Infections

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Mohammad Al-Najjar, PhD

  Faculty of Pharmacy, Applied Science Private University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 10, 2021
• Study Start: December 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: September 30, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

JO (1)