NCT06350448

Washed Microbiota Transplantation for Rhinitis

Efficacy and Safety of Washed Microbiota Transplantation for Rhinitis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinitis

Interventions

Type	Name	Description
DRUG	Washed Microbiota Transplantation	Washed microbiota suspension (5U) delivered through nasogastric tube, nasojejunal tube or oral. Dose and frequency: 5U, three times.

Timeline

• Start date: 2024-05-01
• Primary completion: 2029-05-01
• Completion: 2029-08-01
• First posted: 2024-04-05
• Last updated: 2024-04-05

Locations

1 site across 1 country: China