An interventional study of Washed Microbiota Transplantation in Rhinitis, sponsored by The Second Hospital of Nanjing Medical University. Not yet recruiting at 1 site in China. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by The Second Hospital of Nanjing Medical University · Not applicable, Interventional, and Treatment
Among 12 studies in Rhinitis with a site in China — 7 open to participants now, 7 under way, 1 of them phase 3. Rhinitis · China.
Among the 12 studies in Rhinitis with a site in China, this one is one of 3 that started in 2024, is one of 4 with no phase, and was the 5th registered.
246 studies on the registry are indexed under Rhinitis; 22 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 187 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →7 of the 12 studies in Rhinitis with a site in China are open now, in 4 countries. Each count lists the studies.
Of the 15 Rhinitis studies recruiting now, 4 (27%) set no upper age limit and 10 (67%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 6 Years and older · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 3 started in 2024.
Median enrollment 175 across the 8 interventional studies, 190 across the 4 observational. Of the 4 that completed or were terminated, 1 (25%) have results posted.
3 of 12 have an industry lead sponsor. The 10 most frequent:
The Second Hospital of Nanjing Medical University is the lead sponsor of 70 studies on the registry; 36 are open to participants now.
The Second Hospital of Nanjing Medical University has 1 study filed under Rhinitis — fewer than ten, so there is no comparison to draw.
3 of the studies in Rhinitis with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07240376Huazhong University of Science and TechnologyEfficacy and Safety of Stapokibart in Non-Allergic Rhinitis With Eosinophilia Syndrome | 2026-12-31 |
| NCT06370468Zheng Liu ENTThe Epidemiological and Intrinsic Characteristics of Chronic Rhinitis | 2027-05-01 |
| NCT06870292Xu YuPosterior Nasal Nerve Combined With Anterior Ethmoid Neurotomy for Idiopathic Rhinitis | 2027-10-31 |
Among the 12 studies in Rhinitis with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must meet all of the following inclusion criteria to enter the study:
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Exclusion Criteria:
Subjects meeting any of the following exclusion criteria must be excluded from the study:
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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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo once WMT a day for three consecutive days
Drug: Washed Microbiota Transplantation
Washed microbiota suspension (5U) delivered through nasogastric tube, nasojejunal tube or oral. Dose and frequency: 5U, three times.
Also known as: Fecal Microbiota Transplantation
Changes in the reflective total nasal symptom score (rTNSS)
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).
Time frame: baseline, four weeks, eight weeks, twelve weeks post WMT
Changes in the combined symptoms and medication score (CSMS)
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.
Time frame: baseline, four weeks, eight 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, four weeks, eight 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, four weeks, eight weeks, twelve weeks post WMT
Specific IgE
The immunologic function is evaluated through specific IgE.
Time frame: baseline, twelve weeks post WMT
Inflammatory factors
The immunologic function is evaluated through inflammatory factors.
Time frame: baseline, one day, twelve weeks post WMT
Flow cytometric analysis of lymphocyte clusters
The immunologic function is evaluated through flow cytometric analysis of lymphocyte clusters.
Time frame: baseline, one day, 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, eight weeks, twelve weeks post WMT
Start is estimated for May 2024; primary completion for May 2029, 60 months later.
Of 38 interventional studies with no phase under Rhinitis, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's planned 60 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ornidazole
The Second Hospital of Nanjing Medical University