Allergic RhinitisMICRORINNCT03946553
The Dysbiosis of the Intestinal Microbiota in Individuals With Allergic Rhinitis (MICRORIN)
An observational study of Allergic Rhinitis, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 17 May 2019to 21 Jun 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
- Men and women over 18 years of age.
- Sign the informed consent.
- Do not present any signs or symptoms of RA.
Who cannot join
- 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).
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Technological Centre of Nutrition and Health (Eurecat-Reus)
Reus, Tarragona, 43203
About this study
Official title: The Dysbiosis of the Intestinal Microbiota in Individuals With Allergic Rhinitis: an Observational Study (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.
- Conditions
- Allergic Rhinitis
- Keywords
- intestinal microbiota, immunological markers
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Allergic Rhinitis Group | Individuals with allergic rhinitis | |
| Control Group | Individuals without allergic rhinitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Day 1
Secondary outcomes (3)
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.
Measured: At Day 1
Immunological markers in faeces
Quantification of Immunoglobulin (Ig) A levels in faeces by ELISA kit as a marker of intestinal inflammatory response.
Measured: At Day 1.
Immunological markers in blood
Quantification of IgE by Phadiatop adults.
Measured: At Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start17 May 2019
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 51 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Technological Centre of Nutrition and Health, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Technological Centre of Nutrition and Health, Biopolis S.L., Hospital Universitari Sant Joan de Reus
- Responsible party
- Sponsor
- Investigators
- Rosa Solà, Dr, Principal investigator, UTNS (Eurecat_Reus)/HUSJR. Reus, Tarragona, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946553
- Sponsor's protocol ID
- MICRORIN
- Acronym
- MICRORIN
- Status last verified
- Feb 2022
- First submitted
- 9 May 2019
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dysbiosis of the Intestinal Microbiota in Individuals With Allergic Rhinitis: an Observational Study (MICRORIN)
- ClinicalTrials.gov ID
- NCT03946553
- Acronym / sponsor ID
- MICRORIN / MICRORIN
- Conditions
- Allergic Rhinitis
- Keywords
- intestinal microbiota, immunological markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Technological Centre of Nutrition and Health, SpainUniversity, hospital or other
- Collaborators
- Technological Centre of Nutrition and Health, Biopolis S.L., Hospital Universitari Sant Joan de Reus
- Study start
- 17 May 2019 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergic Rhinitis Group | – | –Individuals with allergic rhinitis |
| Control Group | – | –Individuals without allergic rhinitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- Men and women over 18 years of age.
- Sign the informed consent.
- Present, according to the ARIA classification (Allergic Rhinitis ans its impact on
- Individuals presenting Persistent or Perennial type of RA, in which signs are present:
- Men and women over 18 years of age.
Key exclusion criteria (19 listed)
- Purulent Rhinorrhea.
- Being pregnant.
- Be in breastfeeding period.
- Having diabetes (glucose ≥ 126 mg/dL).
- BMI values > 30 kg/m^2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Allergic Rhinitis Group |
Primary outcome
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.
3 secondary outcomes
Inflammatory markers in blood
Time frame: At Day 1
Immunological markers in faeces
Time frame: At Day 1.
Immunological markers in blood
Time frame: At Day 1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link provided by the sponsor.
- Biopolis S.L.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Solà, Dr principal investigator
UTNS (Eurecat_Reus)/HUSJR. Reus, Tarragona, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal microbiota characterization (time frame: At Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.