Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350448
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-04-01
Brief Title:
Washed Microbiota Transplantation for Rhinitis
Sponsor:
The Second Hospital of Nanjing Medical University
Organization:
The Second Hospital of Nanjing Medical University
Study Overview
Official Title:
Efficacy and Safety of Washed Microbiota Transplantation for Rhinitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None