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

The Dysbiosis of the Intestinal Microbiota in Individuals With Allergic Rhinitis: an Observational Study (MICRORIN)

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Other

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43203
      • Technological Centre of Nutrition and Health (Eurecat-Reus)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria Allergic Rhinitis population:

1. Men and women over 18 years of age.
2. Sign the informed consent.

3. 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).

4. 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.

Exclusion Criteria Allergic Rhinitis population:

1. Purulent Rhinorrhea.
2. Being pregnant.
3. Be in breastfeeding period.
4. Having diabetes (glucose ≥ 126 mg/dL).
5. BMI values > 30 kg/m^2.
6. Present dyslipidemia (LDL cholesterol ≥ 189 mg/dL and/or triglycerides ≥ 350 mg/dL).
7. Systolic Blood Pressure ≥ 160 mmHg and/or Diastolic Blood Pressure ≥ 100 mmHg.
8. Have received treatment with antibiotics 30 days before the start of the study.
9. Have received treatment with corticosteroids 30 days before the start of the study.
10. Individuals who usually intake prebiotics and/or probiotics supplements 30 days before the start of the study.

Inclusion Criteria Control population:

1. Men and women over 18 years of age.
2. Sign the informed consent.
3. Do not present any signs or symptoms of RA.

Exclusion Criteria Control population:

1. Being pregnant.
2. Be in breastfeeding period.
3. Having diabetes (glucose ≥ 126 mg/dL).
4. BMI values > 30 kg/m^2.
5. Present dyslipidemia (LDL cholesterol ≥ 189 mg/dL and/or triglycerides ≥ 350 mg/dL).
6. Systolic Blood Pressure ≥ 160 mmHg and/or Diastolic Blood Pressure ≥ 100 mmHg.
7. Have received treatment with antibiotics 30 days before the start of the study.
8. Have received treatment with corticosteroids 30 days before the start of the study.
9. Individuals who usually intake prebiotics and/or probiotics supplements 30 days before the start of the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Allergic Rhinitis Group; Individuals with allergic rhinitis
Control Group; Individuals without allergic rhinitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Technological Centre of Nutrition and Health. Eurecat_Reus.
• Biopolis S.L.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2019
• Primary Completion (ACTUAL): June 21, 2019
• Study Completion (ACTUAL): June 21, 2019

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (ACTUAL): May 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: intestinal microbiota; immunological markers
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Dysbiosis
• Other Study ID Numbers: MICRORIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No