Rhinitis, Allergic
Conditions
Keywords
washed microbiota transplantation, allergic rhinitis, reflective total nasal symptom score, rhinoconjunctivitis quality of life questionnaire score, gut microbiota
Brief summary
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.
Detailed description
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. The prevalence of AR has been reported from 5% to 50% worldwide which is dependent on the method of diagnosis and age of participants studied. AR is often co-morbid with asthma and/or conjunctivitis, which affects patients' daily life and carries a huge economic burden. Increasing evidence showed that gut microbiota can influence the development of AR. Fecal Microbiota transplantation (FMT), the most classic way to treat diseases using gut microbiota, refers to the transplantation of functional microbiota in the feces of healthy people into the intestines of patients. It can reconstruct the overall gut microbiota of patients, thus treating gastrointestinal disease and external gastrointestinal diseases of patients. Washed microbiota transplantation (WMT), a new stage of FMT, is based on the automatic microfiltration machine (GenFMTer, Nanjing, China) and the following repeated centrifugation plus suspension with support from specific facilities. Compared with manual FMT, WMT can reduce the rate of adverseevents (such as fever, diarrhea, abdominal pain, abdominal distension, nausea and vomiting, etc.) without affecting the efficacy. In clinical practice, we found that WMT could significantly improve the nasal symptoms of AR. This clinical trial aims to evaluate the efficacy and safety of WMT for AR.
Interventions
Patients take four capsules containing washed microbiota once a day for five consecutive days
DRUGPlacebo
Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 years old. 2. Meets the diagnostic criteria for allergic rhinitis. 3. rTNSS score greater than or equal to 6 points. 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
1. Patients with acute nasosinusitis or upper respiratory tract infection. 2. Patients diagnosed with chronic sinusitis, nasal septum deviation, nasal polyps, nasal tumors, and other nasal diseases or have undergone nasal surgery. 3. Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the past two weeks. 4. Patients with poor lung function. 5. Patients with severe liver, kidney, and heart diseases 6. Patients with known psychiatric or neurological diseases. 7. Patients who use antihistamines, glucocorticoids, decongestants, mast cell membrane stabilizers, leukotriene antagonists in the past two weeks. 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the reflective total nasal symptom score (rTNSS) | baseline, one weeks, four weeks, twelve weeks post WMT | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the single reflective nasal symptoms score | baseline, one weeks, four weeks, twelve weeks post WMT | 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). |
| Changes in the concentration of specific IgE | baseline, one day, four weeks, twelve weeks post WMT | The immunologic function is evaluated through specific IgE. |
| Changes in the concentration of inflammatory factors | baseline, one day, four weeks, twelve weeks post WMT | The immunologic function is evaluated through inflammatory factors. |
| Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score | baseline, one weeks, four weeks, twelve weeks post WMT | 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)). |
| The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 | One day, one week, four weeks, twelve weeks post WMT | The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.). |
| Changes in the Modified Lund-Kennedy endoscopic score | baseline, four weeks, twelve weeks post WMT | Modified Lund-Kennedy endoscopic score scoring system is based on assessing polyps, oedema, and discharge. |
| Changes in composition and metabolites of gut microbiota and nasal microbiota | baseline, one day, four weeks, twelve weeks post WMT | The composition of the gut microbiota and nasal microbiota is evaluated by sequencing fecal metagenome. We evaluate the differences in the structure and its metabolism at the phylum, genus and species levels. |
| Changes in the number of immune cell | baseline, one day, four weeks, twelve weeks post WMT | The immunologic function is evaluated through flow cytometric analysis of lymphocyte clusters. |
Countries
China
Contacts
Primary ContactFaming Zhang, MD,PhD
Outcome results
None listed