The Dysbiosis of the Intestinal Microbiota in Individuals With Allergic Rhinitis (MICRORIN)

Completed

• Conditions: Allergic Rhinitis

• Registration Number: NCT03946553
• Lead Sponsor: Technological Centre of Nutrition and Health, Spain

Brief Summary

Allergic rhinitis (AR) is triggered by environmental allergens such as pollen and mites, and is associated with several symptoms such as itching and nasal congestion, sneezing or tearing and redness of the eyes. RA can affect patients life quality who suffer it, reducing the quality of sleep and cognitive function, causing irritability and fatigue and, consequently a decrease in work performance.

Because the existing pharmacological treatments for RA are not entirely effective, it is of interest to find other means to enhance the effects of these drugs and decrease more effectively the signs and symptoms associated with RA. In this context, RA has been related to an alteration of the intestinal microbiota (MI).However, there is a need to characterize in detail the MI of individuals who suffer RA.

The main objective of the present study is to characterize the MI of individuals with RA, compared with people without RA. In addition, the secondary objective is to study the association between characteristics of the MI of individuals with RA and different immunological markers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-10
• Study Start: 2019-05-17
• Primary Completion: 2019-06-21
• Study Completion: 2019-06-21
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-25
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal microbiota characterization	At Day 1	Taxonomic identification of the intestinal microbiota of the participants by sequencing the fecal DNA samples using MiSeq platform of Illumina in combination with 250/300PE.

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers in blood	At Day 1	Quantification of the pro-inflammatory markers Interleuquin (IL)-6 and TNFalpha and of the anti-inflammatory marker IL-10 in blood by ELISA kits.
Immunological markers in faeces	At Day 1.	Quantification of Immunoglobulin (Ig) A levels in faeces by ELISA kit as a marker of intestinal inflammatory response.
Immunological markers in blood	At Day 1.	Quantification of IgE by Phadiatop adults.

Trial Locations

Locations (1)

Technological Centre of Nutrition and Health (Eurecat-Reus); 🇪🇸 Reus, Tarragona, Spain