Washed Microbiota Transplantation for Rhinitis
ConditionRhinitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorThe Second Hospital of Nanjing Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 6 years.
Patient should have two or more nasal symptoms （nasal congestion, rhinorrhea, nasal itching, and sneezing） for at least 1 hour daily.
Reflective total nasal symptom score ≥ 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.
Disqualifiers
Patients with acute infectious rhinitis or upper respiratory tract infection.
Patients diagnosed with chronic sinusitis, severe nasal septum deviation, nasal polyps, nasal tumors, and other nasal diseases by nasal endoscopy and sinus CT.
Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the previous week.
Patients with uncontrolled severe asthma
Trial design
Design model
Single group
Treatments tested in this trial
Washed Microbiota Transplantation
DrugWashed microbiota suspension (5U) delivered through nasogastric tube, nasojejunal tube or oral. Dose and frequency: 5U, three times.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Washed Microbiota TransplantationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in the reflective total nasal symptom score (rTNSS)
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).
Time frame
baseline, four weeks, eight weeks, twelve weeks post WMTSecondary outcomes
1
Changes in the combined symptoms and medication score (CSMS)
CSMS is expressed as the sum of the daily symptom score and daily medication score. Daily symptom score is the average of the two symptoms in the eye (ocular itching/grittiness/redness and ocular tearing) and four symptoms in the nose (nasal congestion, rhinorrhea, nasal itching, and sneezing), Each symptom was rated on a 4-point scale from 0 (none) through 1 (mild), 2 (moderate), and 3 (severe). Daily medication score: 1: Oral and/or topical (eyes or nose) nonsedative H1 antihistamines (H1A); 2: Intranasal corticosteroids (INS) with/without H1A; 3: Oral corticosteroids with/without INS, with/without H1A.
Time frame
baseline, four weeks, eight weeks, twelve weeks post WMT2
Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score
RQLQ is used to evaluate the degree of impact of chronic rhinitis on the quality of life of patients, including activities (3 "patient-specific") limitation, sleep problems (3 items), nose symptoms (4 items), eye symptoms (4 items), non-nose/eye symptoms (7 items), practical problems (3 items) and emotional function (4 items)).
Time frame
baseline, four weeks, eight weeks, twelve weeks post WMT3
Changes in the single reflective nasal symptoms score
The severity of the single reactive nasal symptoms (rhinorrhea, stuffy nose, itchy nose, 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).
Time frame
baseline, four weeks, eight weeks, twelve weeks post WMT4
Specific IgE
The immunologic function is evaluated through specific IgE.
Time frame
baseline, twelve weeks post WMTSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: