An interventional study of Washed Microbiota Transplantation and Placebo in Rhinitis, Allergic, sponsored by The Second Hospital of Nanjing Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by The Second Hospital of Nanjing Medical University · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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.
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Patients take four capsules containing washed microbiota once a day for five consecutive days
Drug: Washed Microbiota Transplantation
Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days
Drug: Placebo
Patients take four capsules containing washed microbiota once a day for five consecutive days
Also known as: Fecal Microbiota Transplantation
Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days
Also known as: Capsule
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 WMT
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 WMT
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 WMT
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 WMT
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 WMT
Changes in the number of immune cell
The immunologic function is evaluated through flow cytometric analysis of lymphocyte clusters.
Time frame: baseline, one day, four weeks, twelve weeks post WMT
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
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: One day, one week, four weeks, twelve weeks post WMT
Changes in the Modified Lund-Kennedy endoscopic score
Modified Lund-Kennedy endoscopic score scoring system is based on assessing polyps, oedema, and discharge.
Time frame: baseline, four weeks, twelve weeks post WMT
Changes in composition and metabolites of gut microbiota and nasal microbiota
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.
Time frame: baseline, one day, four weeks, twelve weeks post WMT
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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The Second Hospital of Nanjing Medical University