Washed Microbiota Transplantation for Rhinitis

NCT06350448 | Not Yet Recruiting

• 1 other identifier: WMT-CN-RH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis

Keywords

washed microbiota transplantation; rhinitis; gut microbiota; allergic rhinitis; non-allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Changes in the reflective total nasal symptom score (rTNSS)

  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 Outcomes (7)

• Changes in the combined symptoms and medication score (CSMS)

  baseline, four weeks, eight weeks, twelve weeks post WMT

• Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score

  baseline, four weeks, eight weeks, twelve weeks post WMT

• Changes in the single reflective nasal symptoms score

  baseline, four weeks, eight weeks, twelve weeks post WMT

• Specific IgE

  baseline, twelve weeks post WMT

• Inflammatory factors

  baseline, one day, twelve weeks post WMT

Study Arms (1)

Washed Microbiota Transplantation

EXPERIMENTAL

Patients undergo once WMT a day for three consecutive days

Drug: Washed Microbiota Transplantation

Interventions

Washed Microbiota Transplantation DRUG

Washed microbiota suspension (5U) delivered through nasogastric tube, nasojejunal tube or oral. Dose and frequency: 5U, three times.

Also known as: Fecal Microbiota Transplantation

Washed Microbiota Transplantation

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Related Publications (10)

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  PMID: 31919742 RESULT

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  PMID: 35714267 RESULT

• Sousa-Pinto B, Azevedo LF, Jutel M, Agache I, Canonica GW, Czarlewski W, Papadopoulos NG, Bergmann KC, Devillier P, Laune D, Klimek L, Anto A, Anto JM, Eklund P, Almeida R, Bedbrook A, Bosnic-Anticevich S, Brough HA, Brussino L, Cardona V, Casale T, Cecchi L, Charpin D, Chivato T, Costa EM, Cruz AA, Dramburg S, Durham SR, De Feo G, Gerth van Wijk R, Fokkens WJ, Gemicioglu B, Haahtela T, Illario M, Ivancevich JC, Kvedariene V, Kuna P, Larenas-Linnemann DE, Makris M, Mathieu-Dupas E, Melen E, Morais-Almeida M, Mosges R, Mullol J, Nadeau KC, Pham-Thi N, O'Hehir R, Regateiro FS, Reitsma S, Samolinski B, Sheikh A, Stellato C, Todo-Bom A, Tomazic PV, Toppila-Salmi S, Valero A, Valiulis A, Ventura MT, Wallace D, Waserman S, Yorgancioglu A, De Vries G, van Eerd M, Zieglmayer P, Zuberbier T, Pfaar O, Almeida Fonseca J, Bousquet J. Development and validation of combined symptom-medication scores for allergic rhinitis. Allergy. 2022 Jul;77(7):2147-2162. doi: 10.1111/all.15199. Epub 2022 Jan 15.

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  PMID: 24815889 RESULT

• Demoly P, Corren J, Creticos P, De Blay F, Gevaert P, Hellings P, Kowal K, Le Gall M, Nenasheva N, Passalacqua G, Pfaar O, Tortajada-Girbes M, Vidal C, Worm M, Casale TB. A 300 IR sublingual tablet is an effective, safe treatment for house dust mite-induced allergic rhinitis: An international, double-blind, placebo-controlled, randomized phase III clinical trial. J Allergy Clin Immunol. 2021 Mar;147(3):1020-1030.e10. doi: 10.1016/j.jaci.2020.07.036. Epub 2020 Sep 2.

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• Khoueir N, Khalaf MG, Assily R, Rassi S, Hamad WA. Intranasal antihistamines in the treatment of idiopathic non-allergic rhinitis: a systematic review and meta-analysis. Rhinology. 2023 Aug 1;61(4):290-296. doi: 10.4193/Rhin21.380.

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MeSH Terms

Conditions

Rhinitis; Rhinitis, Allergic; Common Cold

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Faming Zhang, MD,PhD

  Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, MD,PhD

CONTACT

086-25-58509883; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

CN (1)