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

Allergic Rhinitis Clinical Trial

— MICRORIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03946553
• Other study ID #: MICRORIN
• Status: Completed
• Start date: May 17, 2019
• Est. completion date: June 21, 2019

Study information

• Verified date: February 2022
• Source: Technological Centre of Nutrition and Health, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Dysbiosis
• Rhinitis
• Rhinitis, Allergic

Locations

Country	Name	City	State
Spain	Technological Centre of Nutrition and Health (Eurecat-Reus)	Reus	Tarragona

Sponsors (4)

Lead Sponsor	Collaborator
Technological Centre of Nutrition and Health, Spain	Biopolis S.L., Hospital Universitari Sant Joan de Reus, Technological Centre of Nutrition and Health

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	Immunological markers in blood	Quantification of IgE by Phadiatop adults.	At Day 1.

External Links

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