Washed Microbiota Transplantation for Rhinitis
- Conditions
- Rhinitis
- Interventions
- Registration Number
- NCT06350448
- Lead Sponsor
- The Second Hospital of Nanjing Medical University
- Brief Summary
The common symptoms of rhinitis include nasal itching, sneezing, anterior or posterior nasal leakage, and nasal congestion. Rhinitis can be classified as allergic rhinitis (AR) and non-allergic rhinitis (NAR) based on the presence of a specific allergen. Increasing evidence showed that gut microbiota can influence the development of AR. Although few studies have reported the association between NAR and gut microbiota, we found that washed microbiota transplantation (WMT) could improve nasal symptoms, whether it is AR or NAR. This clinical trial aims to evaluate the efficacy and safety of WMT for rhinitis.
- Detailed Description
Rhinitis affects approximately 20%-40% of the global population, with its incidence increasing every year. And rhinitis is a chronic inflammatory disease of the nasal mucosa, with multiple nasal symptoms, including nasal itching, sneezing, anterior or posterior nasal leakage, and nasal congestion. Besides, rhinitis has also induced secretory otitis media, sinusitis, nasal polyps, and induce or aggravate asthma and other diseases, which affects patients and carries a huge economic burden.
Rhinitis can be classified as allergic rhinitis (AR) and non-allergic rhinitis (NAR) based on the presence of a specific allergen. AR is an allergic chronic inflammatory disease of the nose that involves a variety of inflammatory cells, inflammatory factors, and neurotransmitters, which affects approximately 500 million individuals worldwide. As for NAR, there are relatively few studies, however, it affects the lives of more than 200 million individuals worldwide. Although its etiology is unclear, it involves multiple factors, among which immune factors play an important role in NAR pathogenesis.
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. Although few studies have reported the association between NAR and gut microbiota, the therapeutic effect of WMT on NAR was also often observed. This clinical trial aims to evaluate the efficacy and safety of WMT for rhinitis.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Subjects must meet all of the following inclusion criteria to enter the study:
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Age ≥ 6 years.
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Patient should have two or more nasal symptoms （nasal congestion, rhinorrhea, nasal itching, and sneezing） for at least 1 hour daily.
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Reflective total nasal symptom score ≥ 4
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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.
Subjects meeting any of the following exclusion criteria must be excluded from the study:
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Patients with acute infectious rhinitis or upper respiratory tract infection.
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Patients diagnosed with chronic sinusitis, severe nasal septum deviation, nasal polyps, nasal tumors, and other nasal diseases by nasal endoscopy and sinus CT.
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Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the previous week.
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Patients with uncontrolled severe asthma
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Patients with severe liver, kidney, and heart diseases
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Patients with known psychiatric or neurological diseases.
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Patients who were unable or unwilling to undergo a gastroscopy or colonoscopy.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Washed Microbiota Transplantation Washed Microbiota Transplantation Patients undergo once WMT a day for three consecutive days
- Primary Outcome Measures
Name Time Method Changes in the reflective total nasal symptom score (rTNSS) baseline, four weeks, eight weeks, twelve weeks post WMT rTNSS 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 Outcome Measures
Name Time Method The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 One day, one week, four weeks, eight 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.).
Flow cytometric analysis of lymphocyte clusters baseline, one day, twelve weeks post WMT The immunologic function is evaluated through flow cytometric analysis of lymphocyte clusters.
Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score baseline, four weeks, eight 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)).
Specific IgE baseline, twelve weeks post WMT The immunologic function is evaluated through specific IgE.
Inflammatory factors baseline, one day, twelve weeks post WMT The immunologic function is evaluated through inflammatory factors.
Changes in the combined symptoms and medication score (CSMS) baseline, four weeks, eight weeks, twelve weeks post WMT CSMS is expressed as the sum of the daily symptom score and daily medication score. Daily symptom score is the average of the two symptoms in the eye (ocular itching/grittiness/redness and ocular tearing) and four symptoms in the nose (nasal congestion, rhinorrhea, nasal itching, and sneezing), Each symptom was rated on a 4-point scale from 0 (none) through 1 (mild), 2 (moderate), and 3 (severe). Daily medication score: 1: Oral and/or topical (eyes or nose) nonsedative H1 antihistamines (H1A); 2: Intranasal corticosteroids (INS) with/without H1A; 3: Oral corticosteroids with/without INS, with/without H1A.
Changes in the single reflective nasal symptoms score baseline, four weeks, eight 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).
Trial Locations
- Locations (1)
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China