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Starting soon Not applicable

Washed Microbiota Transplantation for Allergic Rhinitis

NCT06372184 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-06-01
Last updated
2024-05-07

Condition(s) studied

Rhinitis, Allergic

Investigational drug(s) / intervention(s)

Washed Microbiota Transplantation →Placebo

Washed Microbiota Transplantation: Patients take four capsules containing washed microbiota once a day for five consecutive days

Placebo: Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days

Study summary

Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Increasing evidence showed that gut microbiota could influence the development of AR, and we found that washed microbiota transplantation (WMT) could improve nasal symptoms in clinical practice. This clinical trial aims to evaluate the efficacy and safety of WMT for AR.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-65 years old. 2. Meets the diagnostic criteria for allergic rhinitis. 3. rTNSS score greater than or equal to 6 points. 4. The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study. \- Exclusion Criteria: 1. Patients with acute nasosinusitis or upper respiratory tract infection. 2. Patients diagnosed with chronic sinusitis, nasal septum deviation, nasal polyps, nasal tumors, and other nasal diseases or have undergone nasal surgery. 3. Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the past two weeks. 4. Patients with poor lung function. 5. Patients with severe liver, kidney, and heart diseases 6. Patients with known psychiatric or neurological diseases. 7. Patients who use antihistamines, glucocorticoids, decongestants, mast cell membrane stabilizers, leukotriene antagonists in the past two weeks. 8. According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects. \-

Primary outcome measure(s)

  • Changes in the reflective total nasal symptom score (rTNSS) — baseline, one weeks, four weeks, twelve weeks post WMT
    TNSS is expressed as the sum of the scores for the four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing) in the past 12 hours. Each symptom was rated on a 4-point scale from 0 (none) through 1 (mild), 2 (moderate), and 3 (severe).

Trial sites (1)

FacilityCityRegionStatus
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06372184 on ClinicalTrials.gov ↗ ← All trials in China