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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03946553

Recruitment Status Not yet recruiting

First Posted May 10, 2019

Last update posted May 14, 2019

Study Description

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.

  • Condition or Disease:Allergic Rhinitis
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 50 participants
  • Observational Model: Case-Control
  • Time Perspective: Other
  • Official Title: The Dysbiosis of the Intestinal Microbiota in Individuals With Allergic Rhinitis: an Observational Study (MICRORIN)
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: August 2019
  • Estimated Study Completion Date: September 2019
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 1. 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.
  • 2. Immunological markers in blood [ Time Frame: At Day 1. ]
    Quantification of IgE by Phadiatop adults.
  • 3. 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.
  • Biospecimen Retention: Samples With DNA

    fecal samples

Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: 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.
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.

Contacts and Locations
Contacts

Contact: Rosa M Valls, PhD 0034 636944723 estudis@ctns.cat

Contact: Anna Crescenti, PhD +34977770958 anna.crescenti@eurecat.org

Locations

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

Sponsors and Collaborators

Technological Centre of Nutrition and Health, Spain

Technological Centre of Nutrition and Health

Biopolis S.L.

Hospital Universitari Sant Joan de Reus

Investigators

Principal Investigator: Rosa Solà, Dr UTNS (Eurecat_Reus)/HUSJR. Reus, Tarragona, Spain.

More Information
  • Responsible Party: Technological Centre of Nutrition and Health, Spain
  • ClinicalTrials.gov Identifier: NCT03946553 History of Changes
  • Other Study ID Numbers: MICRORIN
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: May 14, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Technological Centre of Nutrition and Health, Spain: intestinal microbiota immunological markers
  • Additional relevant MeSH terms: Rhinitis
    Rhinitis, Allergic
    Dysbiosis