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)
Facility
City
Region
Status
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
More The Second Hospital of Nanjing Medical University trials in China
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.