Washed Microbiota Transplantation for Rhinitis

Официальное название

Efficacy and Safety of Washed Microbiota Transplantation for Rhinitis

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Changes in the reflective total nasal symptom score (rTNSS) [Срок оценки: baseline, four weeks, eight weeks, twelve weeks post WMT]

Вторичные конечные точки (7)

• Changes in the combined symptoms and medication score (CSMS) [Срок оценки: baseline, four weeks, eight weeks, twelve weeks post WMT]
• Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score [Срок оценки: baseline, four weeks, eight weeks, twelve weeks post WMT]
• Changes in the single reflective nasal symptoms score [Срок оценки: baseline, four weeks, eight weeks, twelve weeks post WMT]
• Specific IgE [Срок оценки: baseline, twelve weeks post WMT]
• Inflammatory factors [Срок оценки: baseline, one day, twelve weeks post WMT]
• Flow cytometric analysis of lymphocyte clusters [Срок оценки: baseline, one day, twelve weeks post WMT]
• The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 [Срок оценки: One day, one week, four weeks, eight weeks, twelve weeks post WMT]

Критерии участия

Критерии включения

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

• 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.

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Критерии исключения

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

• 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.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical U — Нанкин

Публикации

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• Del Signore AG, Greene JB, Russell JL, Yen DM, O'Malley EM, Schlosser RJ. Cryotherapy for treatment of chronic rhinitis: 3-month outcomes of a randomized, sham-controlled trial. Int Forum Allergy Rhinol. 2022 Jan;12(1):51-61. doi: 10.1002/alr.22868. Epub 2021 Aug 6. PMID 34355872
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• 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, PMID 34932829
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Идентификаторы

NCT: NCT06350448 · WMT-CN-RH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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