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CompletedNCT03946553MICRORINUpdated Feb 28, 2022

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

An observational study in Allergic Rhinitis, sponsored by Technological Centre of Nutrition and Health, Spain. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-28.

Sponsored by Technological Centre of Nutrition and Health, Spain · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
51
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Allergic Rhinitis

Keywords

  • intestinal microbiota
  • immunological markers
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In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 51 is below the median of 141 across 172 observational studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Technological Centre of Nutrition and Health, Spain is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Eligibility criteria

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.
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Study design

Observational model
Case-control
Time perspective
Other
Enrollment
51 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Allergic Rhinitis Group

    Individuals with allergic rhinitis

  • Control Group

    Individuals without allergic rhinitis

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What researchers measure

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.

    Time frame: At Day 1

Secondary outcomes

  1. 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.

    Time frame: At Day 1

  2. Immunological markers in faeces

    Quantification of Immunoglobulin (Ig) A levels in faeces by ELISA kit as a marker of intestinal inflammatory response.

    Time frame: At Day 1.

  3. Immunological markers in blood

    Quantification of IgE by Phadiatop adults.

    Time frame: At Day 1.

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Study locations

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

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03946553
Lead sponsor
Technological Centre of Nutrition and Health, Spain
Collaborators
Technological Centre of Nutrition and Health, Biopolis S.L., Hospital Universitari Sant Joan de Reus
Responsible party
Sponsor
First posted
May 10, 2019
Start date
May 17, 2019
Primary completion
Jun 21, 2019
Completion
Jun 21, 2019
Last update
Feb 28, 2022

Study contacts

Rosa Solà, Dr
principal investigator · UTNS (Eurecat_Reus)/HUSJR. Reus, Tarragona, Spain.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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