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出境医 / 临床实验 / The Dysbiosis of the Intestinal Microbiota in Individuals With Allergic Rhinitis (MICRORIN) (MICRORIN)

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

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

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 1 Day
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
Arms and Interventions
Group/Cohort
Allergic Rhinitis Group
Individuals with allergic rhinitis
Control Group
Individuals without allergic rhinitis
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. 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.


Biospecimen Retention:   Samples With DNA
fecal samples

Eligibility Criteria
Layout table for eligibility information
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
Layout table for location contacts
Contact: Rosa M Valls, PhD 0034 636944723 estudis@ctns.cat
Contact: Anna Crescenti, PhD +34977770958 anna.crescenti@eurecat.org

Locations
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Spain
Technological Centre of Nutrition and Health (Eurecat-Reus)
Reus, Tarragona, Spain, 43203
Contact: Rosa Valls, PhD    +34 636 944 723    estudis@ctns.cat   
Contact: Anna Crescenti, PhD    +34 977 77 09 58    anna.crescenti@eurecat.org   
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
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Principal Investigator: Rosa Solà, Dr UTNS (Eurecat_Reus)/HUSJR. Reus, Tarragona, Spain.
Tracking Information
First Submitted Date May 9, 2019
First Posted Date May 10, 2019
Last Update Posted Date May 14, 2019
Estimated Study Start Date May 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2019) 		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.
Original Primary Outcome Measures
 (submitted: May 9, 2019) 		Intestinal microbiota characterization [ Time Frame: In one point the in inclusion visit. ]
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.
Change History
Current Secondary Outcome Measures
 (submitted: May 10, 2019)
  • 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.
  • 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.
  • Immunological markers in blood [ Time Frame: At Day 1. ]
    Quantification of IgE by Phadiatop adults.
Original Secondary Outcome Measures
 (submitted: May 9, 2019)
  • Inflammatory markers in blood [ Time Frame: In one point in the inclusion visit. ]
    Quantification 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 faeces [ Time Frame: In one point in the inclusion visit. ]
    Quantification of Immunoglobulin (Ig) A levels in faeces by ELISA kit as a marker of intestinal inflammatory response.
  • Immunological markers in blood [ Time Frame: In one point in the inclusion visit. ]
    Quantification of immunological markers by Phadiatop adults.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Dysbiosis of the Intestinal Microbiota in Individuals With Allergic Rhinitis (MICRORIN)
Official Title The Dysbiosis of the Intestinal Microbiota in Individuals With Allergic Rhinitis: an Observational Study (MICRORIN)
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration 1 Day
Biospecimen Retention:   Samples With DNA
Description:
fecal samples
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.
Condition Allergic Rhinitis
Intervention Not Provided
Study Groups/Cohorts
  • Allergic Rhinitis Group
    Individuals with allergic rhinitis
  • Control Group
    Individuals without allergic rhinitis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 9, 2019) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03946553
Other Study ID Numbers MICRORIN
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Technological Centre of Nutrition and Health, Spain
Study Sponsor Technological Centre of Nutrition and Health, Spain
Collaborators
  • 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.
PRS Account Technological Centre of Nutrition and Health, Spain
Verification Date May 2019

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