Washed Microbiota Transplantation for Allergic Rhinitis

April 15, 2024 updated by: Faming Zhang, The Second Hospital of Nanjing Medical University

Efficacy and Safety of Washed Microbiota Transplantation for Allergic Rhinitis: A Single-center, Randomized, Double-blind, Placebo-controlled Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 and/or 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.

Study Type

Interventional

Enrollment (Estimated)

32

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-65 years old.
  2. Meets the diagnostic criteria for allergic rhinitis.
  3. rTNSS score greater than or equal to 6 points.

  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:

  1. Patients with acute nasosinusitis or upper respiratory tract infection.
  2. Patients diagnosed with chronic sinusitis, nasal septum deviation, nasal polyps, nasal tumors, and other nasal diseases or have undergone nasal surgery.
  3. Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the past two weeks.
  4. Patients with poor lung function.
  5. Patients with severe liver, kidney, and heart diseases
  6. Patients with known psychiatric or neurological diseases.
  7. Patients who use antihistamines, glucocorticoids, decongestants, mast cell membrane stabilizers, leukotriene antagonists in the past two weeks.

  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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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 colonic transendoscopic enteral tube for three consecutive days.
Other Names:
  • Fecal Microbiota Transplantation
Placebo Comparator: Placebo
Patients undergo once equal volume placebo a day for three consecutive days
Drug: Placebo
Isovolumetric placebo delivered through colonic transendoscopic enteral tube for three consecutive days.
Other Names:
  • Normal saline

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, one weeks, four weeks, twelve weeks post WMT
TNSS 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, one weeks, four 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, one weeks, four 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, one weeks, four weeks, twelve weeks post WMT
Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score
Time Frame: baseline, one weeks, four 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, one weeks, four weeks, twelve weeks post WMT
Changes in the single reflective nasal symptoms score
Time Frame: baseline, one weeks, four 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, one weeks, four weeks, twelve weeks post WMT
Specific IgE
Time Frame: baseline, one day, four weeks, twelve weeks post WMT
The immunologic function is evaluated through specific IgE.
baseline, one day, four weeks, twelve weeks post WMT
Inflammatory factors
Time Frame: baseline, one day, four weeks, twelve weeks post WMT
The immunologic function is evaluated through inflammatory factors.
baseline, one day, four weeks, twelve weeks post WMT
Flow cytometric analysis of lymphocyte clusters
Time Frame: baseline, one day, four weeks, twelve weeks post WMT
The immunologic function is evaluated through flow cytometric analysis of lymphocyte clusters.
baseline, one day, four weeks, 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, 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, twelve weeks post WMT
Changes in the Modified Lund-Kennedy endoscopic score
Time Frame: baseline, four weeks, twelve weeks post WMT
Modified Lund-Kennedy endoscopic score scoring system is based on assessing polyps, oedema, and discharge.
baseline, four weeks, twelve weeks post WMT
The changes in composition and metabolites of gut microbiota and nasal microbiota
Time Frame: baseline, one day, four weeks, twelve weeks post WMT
The composition of the gut microbiota and nasal microbiota is evaluated by sequencing fecal metagenome. We evaluate the differences in the structure and its metabolism at the phylum, genus and species levels.
baseline, one day, four 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, The Second 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)

June 1, 2024

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMT-AR-RCT

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.

Clinical Trials on Rhinitis, Allergic

Clinical Trials on Washed Microbiota Transplantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe