Washed Microbiota Transplantation: Washed microbiota suspension (5U) delivered through nasogastric tube, nasojejunal tube or oral. Dose and frequency: 5U, three times.
Study summary
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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
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.
\-
Primary outcome measure(s)
Changes in the reflective total nasal symptom score (rTNSS) — baseline, four weeks, eight weeks, twelve weeks post WMT rTNSS 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 on our Cookie Policy page. See also our Privacy Policy.