Washed Microbiota Transplantation for Allergic Rhinitis
ConditionRhinitis, Allergic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Second Hospital of Nanjing Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years old.
Meets the diagnostic criteria for allergic rhinitis.
rTNSS score greater than or equal to 6 points.
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 nasosinusitis or upper respiratory tract infection.
Patients diagnosed with chronic sinusitis, nasal septum deviation, nasal polyps, nasal tumors, and other nasal diseases or have undergone nasal surgery.
Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the past two weeks.
Patients with poor lung function.
Trial design
Design model
Parallel
Treatments tested in this trial
Washed Microbiota Transplantation
DrugPatients take four capsules containing washed microbiota once a day for five consecutive days
Placebo
DrugPatients take four capsules in the same packaging as the experimental group once a day for five consecutive days
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Washed microbiota transplantationExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in the reflective total nasal symptom score (rTNSS)
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).
Time frame
baseline, one weeks, four weeks, twelve weeks post WMTSecondary outcomes
1
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, one weeks, four weeks, twelve weeks post WMT2
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, one weeks, four weeks, twelve weeks post WMT3
Changes in the concentration of specific IgE
The immunologic function is evaluated through specific IgE.
Time frame
baseline, one day, four weeks, twelve weeks post WMT4
Changes in the concentration of inflammatory factors
The immunologic function is evaluated through inflammatory factors.
Time frame
baseline, one day, four weeks, twelve weeks post WMTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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