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Washed Microbiota Transplantation for Patients With 2019-nCoV Infection

NCT04251767 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-03-17

No results posted yet for this study

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.

Conditions

  • COVID-19 Complicated With Refractory Intestinal Infections

Interventions

OTHER

washed microbiota transplantation

Washed microbiota suspension (5u) delivered through nasogastric tube, nasojejunal tube or oral. Dose and frequency: 5u, once.

OTHER

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.

Sponsors & Collaborators

  • The Second Hospital of Nanjing Medical University

    lead OTHER

Principal Investigators

  • Faming Zhang, MD; PHD · The Second Hospital of Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04251767 on ClinicalTrials.gov