Washed Microbiota Transplantation for Rhinitis

April 1, 2024 updated by: Faming Zhang, The Second Hospital of Nanjing Medical University

Efficacy and Safety of Washed Microbiota Transplantation for Rhinitis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to enter the study:

  1. Age ≥ 6 years.
  2. Patient should have two or more nasal symptoms （nasal congestion, rhinorrhea, nasal itching, and sneezing） for at least 1 hour daily.
  3. Reflective total nasal symptom score ≥ 4

  4. 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.

    -

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria must be excluded from the study:

  1. Patients with acute infectious rhinitis or upper respiratory tract infection.
  2. Patients diagnosed with chronic sinusitis, severe nasal septum deviation, nasal polyps, nasal tumors, and other nasal diseases by nasal endoscopy and sinus CT.
  3. Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the previous week.
  4. Patients with uncontrolled severe asthma
  5. Patients with severe liver, kidney, and heart diseases
  6. Patients with known psychiatric or neurological diseases.
  7. Patients who were unable or unwilling to undergo a gastroscopy or colonoscopy.

  8. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Washed Microbiota Transplantation
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.
Other Names:
  • Fecal Microbiota Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the reflective total nasal symptom score (rTNSS)
Time Frame: 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).
baseline, four weeks, eight weeks, twelve weeks post WMT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the combined symptoms and medication score (CSMS)
Time Frame: 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.
baseline, four weeks, eight weeks, twelve weeks post WMT
Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score
Time Frame: 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)).
baseline, four weeks, eight weeks, twelve weeks post WMT
Changes in the single reflective nasal symptoms score
Time Frame: 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).
baseline, four weeks, eight weeks, twelve weeks post WMT
Specific IgE
Time Frame: baseline, twelve weeks post WMT
The immunologic function is evaluated through specific IgE.
baseline, twelve weeks post WMT
Inflammatory factors
Time Frame: baseline, one day, twelve weeks post WMT
The immunologic function is evaluated through inflammatory factors.
baseline, one day, twelve weeks post WMT
Flow cytometric analysis of lymphocyte clusters
Time Frame: baseline, one day, twelve weeks post WMT
The immunologic function is evaluated through flow cytometric analysis of lymphocyte clusters.
baseline, one day, twelve weeks post WMT
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
Time Frame: 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.).
One day, one week, four weeks, eight weeks, twelve weeks post WMT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Nanjing Medical University

Investigators

  • Principal Investigator: Faming Zhang, MD,PhD, Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMT-CN-RH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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