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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03946553
Acronym
MICRORIN
Enrollment
51
Registered
2019-05-10
Start date
2019-05-17
Completion date
2019-06-21
Last updated
2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

intestinal microbiota, immunological markers

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.

Interventions

None listed

Sponsors

Technological Centre of Nutrition and Health
CollaboratorOTHER
Biopolis S.L.
CollaboratorINDUSTRY
Hospital Universitari Sant Joan de Reus
CollaboratorOTHER
Technological Centre of Nutrition and Health, Spain
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Intestinal microbiota characterizationAt Day 1Taxonomic 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

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026