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Study for the difference of bacterial flora in nasal cavity and intestinal tract between patients with allergic rhinitis and healthy people

Study for the difference of bacterial flora in nasal cavity and intestinal tract between patients with allergic rhinitis and healthy people

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900028613
Enrollment
Unknown
Registered
2019-12-29
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-01-06

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

Conditions

Allergy rhinitis

Interventions

allergy rhinitis group:No.1 rhinitis

Sponsors

Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with allergy rhinitis; 2. aged 18-65 years; 3. meet the international diagnostic standard of AR (ARIA) [18]: (1) symptoms: sneezing, clear water like snot, rhinopruritus, nasal obstruction and other symptoms appear 2 or more, the symptoms last or accumulate for more than 1h every day; (2) signs: common nasal mucosa is pale, edematous, nasal water like secretion; (3) allergen detection: At least one allergen SPT and / or serum specific IgE is positive; 3. Symptom attack >=4D / week, and >=4 consecutive weeks; 4. At least 8 points of TNSS within 12 hours, including >=2 points for nasal obstruction and >=2 points for sneezing or itching. Informed consent, signing informed consent and voluntary test. The healthy population should meet all the following conditions: 1. no basic medical history, normal physical examination indicators; 2. no allergic history. Informed consent, signing informed consent and voluntary test.

Exclusion criteria

Exclusion criteria: 1. Five-sensory diseases and respiratory diseases (including chronic obstructive pulmonary disease (COPD), emphysema, bronchiectasis, tuberculosis, pneumonia, bronchial asthma, secretory otitis media, etc.) and upper breath Inhalatory tract infection with asthma attack; 2. Postural hypotension, organic heart disease or clinically significant ECG changes; 3. Patients with thyroid disease, diabetes mellitus, hypoglycemia, cardiovascular and cerebrovascular disease, prostatic hypertrophy, glaucoma, epilepsy history, the value of liver function (ALT, AST) as well as renal function (BUN, Cr) was 1.5 times higher than the normal value, hematopoietic dysfunction, gastrointestinal diseases, malignant tumors and other serious diseases that may affect the correct evaluation of curative effect; 4. Patients had a history of mental and neurological diseases; 5. Patients who had received the following treatment before the experiment: immunotherapy within 12 months; long-acting glucocorticoid Injection therapy within 3 months; Asmidazole within 6 weeks; Glucocorticoids for systemic or local use within 2 weeks (inhalation or nasal spray); Sodium cromoglycerin or Naidomide within 1 month; Long-acting antihistamines within 2 weeks; Short-acting antihistamines within 1 week; Ketotifen, tricyclic antidepressants, macrolides and antifungal drugs within 2 weeks; Systemic or local nasal decongestants within 24h; using anti-histamine drugs, anticholinergics and antiarrhythmic drugs currently; using barbiturates, antispasmodics, phentolamine and digitalis drugs currently; 6. Patients who are allergic to antihistamine, or patients who are known or suspected to be allergic to research drugs (or similar compounds) or their components; 7. Patients who have participated in other drug clinical trials in the past three months; 8. Abnormal physical examination results with clinical significance before admission, which will affect the achievement of the purpose of this study or hinder the realization of compliance with the research procedures according to the judgement of the researchers.

Design outcomes

Primary

MeasureTime frame
TNSS;

Secondary

MeasureTime frame
Nasal flora;Intestinal flora;RQLQ;RMS;IgE;IL-2, IL-4, IL-6, IL-10, TNF-alpha, IIFN-gama;safety;adverse event;

Countries

China

Contacts

Public ContactZhu Libing

Xiamen University

kongbeizi123@163.com+86 13110591893

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 26, 2026