Washed Microbiota Transplantation for Rhinitis

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.

Timeline

Start

2024-05-01

Primary completion

2029-05-01

Completion

2029-08-01

Publications

• Background Dykewicz MS, Wallace DV, Amrol DJ, Baroody FM, Bernstein JA, Craig TJ, Dinakar C, Ellis AK, Finegold I, Golden DBK, Greenhawt MJ, Hagan JB, Horner CC, Khan DA, Lang DM, Larenas-Linnemann DES, Lieberman JA, Meltzer EO, Oppenheimer JJ, Rank MA, Shaker MS, Shaw JL, Steven GC, Stukus DR, Wang J; Chief Editor(s):; Dykewicz MS, Wallace DV; Joint Task Force on Practice Parameters:; Dinakar C, Ellis AK, Golden DBK, Greenhawt MJ, Horner CC, Khan DA, Lang DM, Lieberman JA, Oppenheimer JJ, Rank MA, Shaker MS, Stukus DR, Wang J; Workgroup Contributors:; Dykewicz MS, Wallace DV, Amrol DJ, Baroody FM, Bernstein JA, Craig TJ, Finegold I, Hagan JB, Larenas-Linnemann DES, Meltzer EO, Shaw JL, Steven GC. Rhinitis 2020: A practice parameter update. J Allergy Clin Immunol. 2020 Oct;146(4):721-767. doi: 10.1016/j.jaci.2020.07.007. Epub 2020 Jul 22.
• Background 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.
• Background Hellings PW, Klimek L, Cingi C, Agache I, Akdis C, Bachert C, Bousquet J, Demoly P, Gevaert P, Hox V, Hupin C, Kalogjera L, Manole F, Mosges R, Mullol J, Muluk NB, Muraro A, Papadopoulos N, Pawankar R, Rondon C, Rundenko M, Seys SF, Toskala E, Van Gerven L, Zhang L, Zhang N, Fokkens WJ. Non-allergic rhinitis: Position paper of the European Academy of Allergy and Clinical Immunology. Allergy. 2017 Nov;72(11):1657-1665. doi: 10.1111/all.13200. Epub 2017 Jun 2.
• Results 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.
• Results 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.
• Results Takashima M, Stolovitzky JP, Ow RA, Silvers SL, Bikhazi NB, Johnson CD. Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial. Int Forum Allergy Rhinol. 2023 Feb;13(2):107-115. doi: 10.1002/alr.23047. Epub 2022 Jul 5.
• Results 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.
• Results Vuurman EF, Vuurman LL, Lutgens I, Kremer B. Allergic rhinitis is a risk factor for traffic safety. Allergy. 2014 Jul;69(7):906-12. doi: 10.1111/all.12418. Epub 2014 May 9.
• Results 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.
• Results 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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Indications