Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372184
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-15
Brief Title:
Washed Microbiota Transplantation for Allergic 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 Allergic Rhinitis A Randomized Double-blind Placebo-controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
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 andor 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
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
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