Washed Microbiota Transplantation for Rhinitis

Launched by THE SECOND HOSPITAL OF NANJING MEDICAL UNIVERSITY · Apr 1, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called washed microbiota transplantation (WMT) for people suffering from rhinitis, which is a condition that causes symptoms like nasal itching, sneezing, and congestion. Rhinitis can be allergic, meaning it’s triggered by things like pollen or dust, or non-allergic, which means it’s caused by other factors. The trial aims to see if WMT can help improve nasal symptoms for both types of rhinitis.

To participate in this study, you must be at least 6 years old and have experienced two or more nasal symptoms for at least one hour each day. You should also have a total nasal symptom score of 4 or higher. However, there are some reasons that might prevent someone from joining, such as having a recent infection, certain nasal conditions, or using medications that affect gut bacteria. If you qualify and decide to take part, you will receive treatment and be monitored for its effects on your symptoms. This trial is currently not recruiting participants yet, but it aims to provide valuable information about this potential new therapy for rhinitis.

Gender

ALL

Eligibility criteria

• 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.
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• 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.
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