Washed Microbiota Transplantation for Allergic Rhinitis
NCT ID: NCT06372184
Last Updated: 2024-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
32 participants
INTERVENTIONAL
2024-06-01
2029-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Washed microbiota transplantation
Patients take four capsules containing washed microbiota once a day for five consecutive days
Washed Microbiota Transplantation
Patients take four capsules containing washed microbiota once a day for five consecutive days
Placebo
Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days
Placebo
Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days
Interventions
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Washed Microbiota Transplantation
Patients take four capsules containing washed microbiota once a day for five consecutive days
Placebo
Patients take four capsules in the same packaging as the experimental group once a day for five consecutive days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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Exclusion Criteria
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.
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18 Years
65 Years
ALL
No
Sponsors
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The Second Hospital of Nanjing Medical University
OTHER
Responsible Party
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Faming Zhang
Professor, Gastroenterology
Principal Investigators
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Faming Zhang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
The Second Hospital of Nanjing Medical University
Locations
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Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wise SK, Damask C, Roland LT, Ebert C, Levy JM, Lin S, Luong A, Rodriguez K, Sedaghat AR, Toskala E, Villwock J, Abdullah B, Akdis C, Alt JA, Ansotegui IJ, Azar A, Baroody F, Benninger MS, Bernstein J, Brook C, Campbell R, Casale T, Chaaban MR, Chew FT, Chambliss J, Cianferoni A, Custovic A, Davis EM, DelGaudio JM, Ellis AK, Flanagan C, Fokkens WJ, Franzese C, Greenhawt M, Gill A, Halderman A, Hohlfeld JM, Incorvaia C, Joe SA, Joshi S, Kuruvilla ME, Kim J, Klein AM, Krouse HJ, Kuan EC, Lang D, Larenas-Linnemann D, Laury AM, Lechner M, Lee SE, Lee VS, Loftus P, Marcus S, Marzouk H, Mattos J, McCoul E, Melen E, Mims JW, Mullol J, Nayak JV, Oppenheimer J, Orlandi RR, Phillips K, Platt M, Ramanathan M Jr, Raymond M, Rhee CS, Reitsma S, Ryan M, Sastre J, Schlosser RJ, Schuman TA, Shaker MS, Sheikh A, Smith KA, Soyka MB, Takashima M, Tang M, Tantilipikorn P, Taw MB, Tversky J, Tyler MA, Veling MC, Wallace D, Wang Y, White A, Zhang L. International consensus statement on allergy and rhinology: Allergic rhinitis - 2023. Int Forum Allergy Rhinol. 2023 Apr;13(4):293-859. doi: 10.1002/alr.23090. Epub 2023 Mar 6.
Bousquet J, Anto JM, Bachert C, Baiardini I, Bosnic-Anticevich S, Walter Canonica G, Melen E, Palomares O, Scadding GK, Togias A, Toppila-Salmi S. Allergic rhinitis. Nat Rev Dis Primers. 2020 Dec 3;6(1):95. doi: 10.1038/s41572-020-00227-0.
Martensson A, Cervin-Hoberg C, Huygens F, Lindstedt M, Sakellariou C, Greiff L, Cervin A. Upper airway microbiome transplantation for patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2023 Jun;13(6):979-988. doi: 10.1002/alr.23122. Epub 2023 Jan 1.
Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.
Schaefer M, Zimmermann K, Enck P. Probiotic treatment (Enterococcus faecalis) improves symptoms of seasonal allergic rhinitis: A randomized controlled trial. Int Forum Allergy Rhinol. 2023 Oct;13(10):1974-1977. doi: 10.1002/alr.23154. Epub 2023 Apr 7. No abstract available.
Anania C, Di Marino VP, Olivero F, De Canditiis D, Brindisi G, Iannilli F, De Castro G, Zicari AM, Duse M. Treatment with a Probiotic Mixture Containing Bifidobacterium animalis Subsp. Lactis BB12 and Enterococcus faecium L3 for the Prevention of Allergic Rhinitis Symptoms in Children: A Randomized Controlled Trial. Nutrients. 2021 Apr 16;13(4):1315. doi: 10.3390/nu13041315.
Kang MG, Han SW, Kang HR, Hong SJ, Kim DH, Choi JH. Probiotic NVP-1703 Alleviates Allergic Rhinitis by Inducing IL-10 Expression: A Four-week Clinical Trial. Nutrients. 2020 May 15;12(5):1427. doi: 10.3390/nu12051427.
Other Identifiers
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WMT-AR-RCT
Identifier Type: -
Identifier Source: org_study_id
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