Efficacy and Safety of Washed Microbiota Transplantation for Rhinitis

WMT-CN-RH

The common symptoms of rhinitis include nasal itching, sneezing, anterior or posterior nasal leakage, and nasal congestion. Rhinitis can be classified as allergic rhinitis (AR) and non-allergic rhinitis (NAR) based on the presence of a specific allergen. Increasing evidence showed that gut microbiota can influence the development of AR. Although few studies have reported the association between NAR and gut microbiota, we found that washed microbiota transplantation (WMT) could improve nasal symptoms, whether it is AR or NAR. This clinical trial aims to evaluate the efficacy and safety of WMT for rhinitis.

2024-05-01

2029-05-01

2029-08-01

Not yet recruiting

40

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to enter the study: 1. Age ≥ 6 years. 2. Patient should have two or more nasal symptoms （nasal congestion, rhinorrhea, nasal itching, and sneezing） for at least 1 hour daily. 3. Reflective total nasal symptom score ≥ 4 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: Subjects meeting any of the following exclusion criteria must be excluded from the study: 1. Patients with acute infectious rhinitis or upper respiratory tract infection. 2. Patients diagnosed with chronic sinusitis, severe nasal septum deviation, nasal polyps, nasal tumors, and other nasal diseases by nasal endoscopy and sinus CT. 3. Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the previous week. 4. Patients with uncontrolled severe asthma 5. Patients with severe liver, kidney, and heart diseases 6. Patients with known psychiatric or neurological diseases. 7. Patients who were unable or unwilling to undergo a gastroscopy or colonoscopy. 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. -

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-04-05