Clinical trial NCT06372184: Washed Microbiota Transplantation for Allergic Rhinitis
Official title: Efficacy and Safety of Washed Microbiota Transplantation for Allergic Rhinitis: A Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rhinitis, Allergic
Keywords: washed microbiota transplantation
allergic rhinitis
reflective total nasal symptom score
rhinoconjunctivitis quality of life questionnaire score
gut microbiota
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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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.

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Primary outcomes:
measure: Changes in the reflective total nasal symptom score (rTNSS)
timeFrame: baseline, one weeks, four weeks, twelve weeks post WMT
Secondary outcomes:
measure: Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score
timeFrame: baseline, one weeks, four weeks, twelve weeks post WMT
measure: Changes in the single reflective nasal symptoms score
timeFrame: baseline, one weeks, four weeks, twelve weeks post WMT
measure: Changes in the concentration of specific IgE
timeFrame: baseline, one day, four weeks, twelve weeks post WMT
measure: Changes in the concentration of inflammatory factors
timeFrame: baseline, one day, four weeks, twelve weeks post WMT
measure: Changes in the number of immune cell
timeFrame: baseline, one day, four weeks, twelve weeks post WMT
measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
timeFrame: One day, one week, four weeks, twelve weeks post WMT
measure: Changes in the Modified Lund-Kennedy endoscopic score
timeFrame: baseline, four weeks, twelve weeks post WMT
measure: Changes in composition and metabolites of gut microbiota and nasal microbiota
timeFrame: baseline, one day, four weeks, twelve weeks post WMT
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Faming Zhang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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