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Washed Microbiota Transplantation for Patients With 2019-nCoV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251767
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

Brief Summary:
Gut dysbiosis co-exists in patients with coronavirus pneumonia. Some of these patients would 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. This clinical trial aims to evaluate the outcome of WMT combining with standard therapy for patients with 2019-novel coronavirus pneumonia, especially for those patients with dysbiosis-related conditions.

Condition or disease Intervention/treatment Phase
2019-nCoV Other: washed microbiota transplantation Other: placebo Not Applicable

Detailed Description:

An ongoing outbreak of 2019 novel coronavirus was reported in Wuhan, China. 2019-nCoV has caused a cluster of pneumonia cases, and posed continuing epidemic threat to China and even global health. Unfortunately, there is currently no specific effective treatment for the viral infection and the related serious complications. It is in urgent need to find a new specific effective treatment for the 2019-nCoV infection. According to Declaration of Helsinki and International Ethical Guidelines for Health-related Research Involving Humans, the desperately ill patients with 2019-nCov infection during disease outbreaks have a moral right to try unvalidated medical interventions (UMIs) and that it is therefore unethical to restrict access to UMIs to the clinical trial context.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Washed Microbiota Transplantation in Patients With 2019-novel Coronavirus Infection
Estimated Study Start Date : February 2, 2020
Estimated Primary Completion Date : April 2, 2020
Estimated Study Completion Date : April 16, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study group
5u washed microbiota suspension administered via nasogastric tube, nasojejunal tube or oral, combining with standard therapy.
Other: washed microbiota transplantation

Washed microbiota suspension delivered through nasogastric tube, nasojejunal tube or oral, combining with standard therapy.

Dose and frequency: 5u, once.

Other Name: microbiota transplantation

Placebo Comparator: 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.
Other: placebo

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 dose and frequency: 5u, once.

Other Name: edible suspension




Primary Outcome Measures :
  1. Number of participants with improvement from severe type to common type [ Time Frame: 2 weeks ]

    Common type: Fever, respiratory tract and other symptoms, imaging examination shows pneumonia;

    Severe type (meeting any of the following): (1) Respiratory distress,respiratory rate ≥ 30 bmp; (2) Oxygen saturation ≤ 93%;(3)PaO2/FiO2 ≤ 300mmHg.

    Critically severe type (meeting any of the following): (1) Respiratory failure requiring mechanical ventilation; (2) Shock; (3) Combining with other organ failures, requiring ICU monitoring and treatment.




Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 14-70 years old
  2. 2019 novel coronavirus pneumonia (severe type)
  3. Subjects voluntarily participate in the clinical trial and sign the informed consent

Exclusion Criteria:

  1. Disturbance of consciousness
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251767


Locations
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China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Investigators
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Principal Investigator: Faming Zhang, MD; PHD The Second Hospital of Nanjing Medical University

Publications:

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Responsible Party: Faming Zhang, Director of Medical Center for Digestive Diseases, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04251767    
Other Study ID Numbers: WMT-YJ-202001
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection