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

NCT03946553 | Completed

• 1 other identifier: MICRORIN
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

intestinal microbiota; immunological markers

Outcome Measures

Primary Outcomes (1)

• Intestinal microbiota characterization

  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.

  At Day 1

Secondary Outcomes (3)

• Inflammatory markers in blood

  At Day 1

• Immunological markers in faeces

  At Day 1.

• Immunological markers in blood

  At Day 1.

Study Arms (2)

Allergic Rhinitis Group

Individuals with allergic rhinitis

Control Group

Individuals without allergic rhinitis

Eligibility Criteria

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

Study Population

In the study will be two types of populations. A population with allergic rhinitis and a population without allergic rhinitis and that serves as control group.

You may qualify if:

• Men and women over 18 years of age.
• Sign the informed consent.
• Present, according to the ARIA classification (Allergic Rhinitis ans its impact on
• Asthma), two or more of the following symptoms for more than one hour a day:
• Aqueous rhinorrhea.
• Sneezing, especially paroxysmal.
• Nasal obstruction.
• Itching or nasal itch.
• Conjunctivitis (itching, lacrimation or redness).
• Individuals presenting Persistent or Perennial type of RA, in which signs are present:
• More than four days a week.
• And for more than four consecutive weeks.

You may not qualify if:

• Purulent Rhinorrhea.
• Being pregnant.
• Be in breastfeeding period.
• Having diabetes (glucose ≥ 126 mg/dL).
• BMI values \> 30 kg/m\^2.
• Present dyslipidemia (LDL cholesterol ≥ 189 mg/dL and/or triglycerides ≥ 350 mg/dL).
• Systolic Blood Pressure ≥ 160 mmHg and/or Diastolic Blood Pressure ≥ 100 mmHg.
• Have received treatment with antibiotics 30 days before the start of the study.
• Have received treatment with corticosteroids 30 days before the start of the study.
• Individuals who usually intake prebiotics and/or probiotics supplements 30 days before the start of the study.
• Men and women over 18 years of age.
• Sign the informed consent.
• Do not present any signs or symptoms of RA.
• Being pregnant.
• Be in breastfeeding period.

Sponsors & Collaborators

• Technological Centre of Nutrition and Health, Spain: lead
• Technological Centre of Nutrition and Health: collaborator
• Biopolis S.L.: collaborator
• Hospital Universitari Sant Joan de Reus: collaborator

Study Sites (1)

Technological Centre of Nutrition and Health (Eurecat-Reus)

Reus, Tarragona, 43203, Spain

Location

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus.
• Biopolis S.L.

Biospecimen

Retention: SAMPLES WITH DNA

fecal samples

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Rosa Solà, Dr

  UTNS (Eurecat_Reus)/HUSJR. Reus, Tarragona, Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 10, 2019
• Study Start: May 17, 2019
• Primary Completion: June 21, 2019
• Study Completion: June 21, 2019
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)