Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
NCT Number: NCT06372184
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210011, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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Exclusion criteria
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Patients take four capsules containing washed microbiota once a day for five consecutive days
Other names: Fecal Microbiota Transplantation
Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days
Other names: Capsule
Time frame: 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).
Time frame: 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)).
Time frame: 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).
Time frame: baseline, one day, four weeks, twelve weeks post WMT
The immunologic function is evaluated through specific IgE.
Time frame: baseline, one day, four weeks, twelve weeks post WMT
The immunologic function is evaluated through inflammatory factors.
Time frame: baseline, one day, four weeks, twelve weeks post WMT
The immunologic function is evaluated through flow cytometric analysis of lymphocyte clusters.
Time frame: 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.).
Time frame: baseline, four weeks, twelve weeks post WMT
Modified Lund-Kennedy endoscopic score scoring system is based on assessing polyps, oedema, and discharge.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
The Second Hospital of Nanjing Medical University
Other
Efficacy and Safety of Washed Microbiota Transplantation for Allergic Rhinitis: A Randomized, Double-blind, Placebo-controlled Study
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