Washed Microbiota Transplantation for Patients With 2019-nCoV Infection
NCT ID: NCT04251767
Last Updated: 2020-03-17
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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WITHDRAWN
NA
INTERVENTIONAL
2020-02-05
2020-04-30
Brief Summary
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Detailed Description
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There is a vital link between the intestinal tract and respiratory tract, which was exemplified by intestinal complications during respiratory disease and vice versa. Some of these patients can develop secondary bacterial infections and antibiotic-associated diarrhea (AAD). The recent study on using washed microbiota transplantation (WMT) as rescue therapy in critically ill patients with AAD demonstrated the important clinical benefits and safety of WMT. Additionally, the recent animal study provided direct evidence supporting that antibiotics could decrease gut microbiota and the lung stromal interferon signature and facilitate early influenza virus replication in lung epithelia. Importantly, the above antibiotics caused negative effects can be reversed by fecal microbiota transplantation (FMT) which suggested that FMT might be able to induce a significant improvement in the respiratory virus infection. Another evidence is that the microbiota could confer protection against certain virus infection such as influenza virus and respiratory syncytial virus by priming the immune response to viral evasion. The above results suggested that FMT might be a new therapeutic option for the treatment of virus-related pneumonia. The methodology of FMT recently was coined as WMT, which is dependent on the automatic facilities and washing process in a laboratory room. Patients underwent WMT with the decreased rate of adverse events and unchanged clinical efficacy in ulcerative colitis and Crohn's disease. This clinical trial aims to evaluate the outcome of WMT combining with standard therapy for patients with novel coronavirus pneumonia, especially for those patients with dysbiosis-related conditions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Observational group
5u washed microbiota suspension administered via nasogastric tube, nasojejunal tube or oral, combining with standard therapy.
washed microbiota transplantation
Washed microbiota suspension (5u) delivered through nasogastric tube, nasojejunal tube or oral.
Dose and frequency: 5u, once.
Control group
5 u placebo (edible suspension of the same color as the washed microbiota suspension) administered via nasogastric tube, nasojejunal tube or oral, combining with standard therapy.
placebo
Placebo (edible suspension of the same color as the washed microbiota suspension，5u) administered via nasogastric tube, nasojejunal tube or oral, combining with standard therapy.
Dose and frequency: 5u, once.
Interventions
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washed microbiota transplantation
Washed microbiota suspension (5u) delivered through nasogastric tube, nasojejunal tube or oral.
Dose and frequency: 5u, once.
placebo
Placebo (edible suspension of the same color as the washed microbiota suspension，5u) administered via nasogastric tube, nasojejunal tube or oral, combining with standard therapy.
Dose and frequency: 5u, once.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 2019 novel coronavirus pneumonia (severe type)
3. Subjects voluntarily participate in the clinical trial and sign the informed consent
Exclusion Criteria
2. Difficulty swallowing and frequent vomiting
3. Patients requiring blood transfusion
4. Pulmonary abscess, hepatitis, cirrhosis, tuberculosis, emphysema and pulmonary infarction
5. Fungal and other identified pathogens infection
6. Heart failure existed before diagnosis of novel coronavirus infection
7. Liver function: alanine aminotransferase \> 500 U/L
8. Patients requiring hemodialysis
9. Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases
10. Other conditions that the investigator considers ineligible for clinical trial
14 Years
70 Years
ALL
No
Sponsors
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The Second Hospital of Nanjing Medical University
OTHER
Responsible Party
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Faming Zhang
Director of Medical Center for Digestive Diseases
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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References
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Bradley KC, Finsterbusch K, Schnepf D, Crotta S, Llorian M, Davidson S, Fuchs SY, Staeheli P, Wack A. Microbiota-Driven Tonic Interferon Signals in Lung Stromal Cells Protect from Influenza Virus Infection. Cell Rep. 2019 Jul 2;28(1):245-256.e4. doi: 10.1016/j.celrep.2019.05.105.
Dai M, Liu Y, Chen W, Buch H, Shan Y, Chang L, Bai Y, Shen C, Zhang X, Huo Y, Huang D, Yang Z, Hu Z, He X, Pan J, Hu L, Pan X, Wu X, Deng B, Li Z, Cui B, Zhang F. Rescue fecal microbiota transplantation for antibiotic-associated diarrhea in critically ill patients. Crit Care. 2019 Oct 21;23(1):324. doi: 10.1186/s13054-019-2604-5.
Ding X, Li Q, Li P, Zhang T, Cui B, Ji G, Lu X, Zhang F. Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis. Drug Saf. 2019 Jul;42(7):869-880. doi: 10.1007/s40264-019-00809-2.
Dominguez-Diaz C, Garcia-Orozco A, Riera-Leal A, Padilla-Arellano JR, Fafutis-Morris M. Microbiota and Its Role on Viral Evasion: Is It With Us or Against Us? Front Cell Infect Microbiol. 2019 Jul 18;9:256. doi: 10.3389/fcimb.2019.00256. eCollection 2019.
Ekbom A, Brandt L, Granath F, Lofdahl CG, Egesten A. Increased risk of both ulcerative colitis and Crohn's disease in a population suffering from COPD. Lung. 2008 May-Jun;186(3):167-172. doi: 10.1007/s00408-008-9080-z. Epub 2008 Mar 11.
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
London AJ. Social value, clinical equipoise, and research in a public health emergency. Bioethics. 2019 Mar;33(3):326-334. doi: 10.1111/bioe.12467. Epub 2018 Jul 27.
Marsland BJ, Trompette A, Gollwitzer ES. The Gut-Lung Axis in Respiratory Disease. Ann Am Thorac Soc. 2015 Nov;12 Suppl 2:S150-6. doi: 10.1513/AnnalsATS.201503-133AW.
Ng SC, Kamm MA, Yeoh YK, Chan PKS, Zuo T, Tang W, Sood A, Andoh A, Ohmiya N, Zhou Y, Ooi CJ, Mahachai V, Wu CY, Zhang F, Sugano K, Chan FKL. Scientific frontiers in faecal microbiota transplantation: joint document of Asia-Pacific Association of Gastroenterology (APAGE) and Asia-Pacific Society for Digestive Endoscopy (APSDE). Gut. 2020 Jan;69(1):83-91. doi: 10.1136/gutjnl-2019-319407. Epub 2019 Oct 14.
Wang H, Cui B, Li Q, Ding X, Li P, Zhang T, Yang X, Ji G, Zhang F. The Safety of Fecal Microbiota Transplantation for Crohn's Disease: Findings from A Long-Term Study. Adv Ther. 2018 Nov;35(11):1935-1944. doi: 10.1007/s12325-018-0800-3. Epub 2018 Oct 16.
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.
Other Identifiers
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WMT-YJ-202001
Identifier Type: -
Identifier Source: org_study_id
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