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NCT Number: NCT03946553

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Technological Centre of Nutrition and Health (Eurecat-Reus)

Reus, Tarragona, 43203, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Allergic Rhinitis population:

  • 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.

Exclusion criteria

Allergic Rhinitis population:

  • 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.

Inclusion criteria

Control population:

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

Exclusion criteria

Control population:

  • 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.

Treatment and study plan

Primary outcomes

  1. Intestinal microbiota characterization

    Time frame: 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 outcomes

  1. Inflammatory markers in blood

    Time frame: 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.

  2. Immunological markers in faeces

    Time frame: At Day 1.

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

  3. Immunological markers in blood

    Time frame: At Day 1.

    Quantification of IgE by Phadiatop adults.

Sponsors and collaborators

Lead sponsor

Technological Centre of Nutrition and Health, Spain

Other

Collaborators

  • Biopolis S.L.
  • Hospital Universitari Sant Joan de Reus
  • Technological Centre of Nutrition and Health

Registry information

Official study title

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

Acronym: MICRORIN

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 10, 2019
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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