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A Controlled Study on Regulation of Systemic Inflammation by Fecal Bacteria Transplantation in Patients With COVID-19. | Clinical Trials | Clareo Health

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A Controlled Study on Regulation of Systemic Inflammation by Fecal Bacteria Transplantation in Patients With COVID-19.

NCT05873348•Shanghai 10th People's Hospital

View on ClinicalTrials.gov

Summary

A total of 30 hospitalized patients with COVID-19 over 60 years old were enrolled in this study and were divided into the experimental group (n=15) and the control group (n=15) at a ratio of 1:1. Both groups were treated according to the 2022 Shanghai guidelines for Diagnosis and Treatment of COVID-19 infection and the hierarchical diagnosis and treatment process. The experimental group was treated with fecal microbiota transplantation (FMT) capsules for 1 week, and the control group was treated with empty capsules. Patients in both groups were followed up for 1 month after discharge. To observe the effect of combined FMT capsule treatment on the regulation of inflammatory factors in peripheral blood and the remodeling of intestinal flora, and to verify its safety.

Eligibility

Age

60 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Over 60 years old, male or female;
•2\. Meet the diagnostic criteria of COVID-19;
•3\. The patient signed the informed consent, agreed to receive FMT capsule treatment, agreed to cooperate with the whole process of the clinical trial, and agreed to collect clinical data and blood, saliva, urine, stool and other samples;
•4\. The patient was able to swallow 3# capsules by herself.

Exclusion Criteria

•1\. Confirmed diagnosis of non-COVID19 pneumonia;
•2\. Critically ill patients requiring mechanical ventilation, or patients who are unable to eat by mouth and swallow 3# capsules;
•3\. Patients who had undergone gastrointestinal surgery;
•4\. Presence of intestinal organic lesions such as congenital megacolon, intestinal obstruction, intussusception, etc.
•5\. Pathological intestinal inflammatory changes, such as inflammatory bowel disease;
•6\. Planned use of antacids, probiotics, antibiotics, FMT and other treatments affecting intestinal flora within the past 3 months or the following 2 months;
•7\. Patients and their families did not agree to receive FMT treatment;
•8\. Patients unable to cooperate with follow-up visits.

Locations (1)

Li Long

Shanghai, China

Key Dates

Start Date

January 10, 2023

Primary Completion Date

March 10, 2023

Completion Date

April 30, 2023

Last Updated

January 12, 2024

Enrollment

ACTUAL participants

Conditions

Fecal Microbiota TransplantationCOVID-19 Infection

Interventions

Fecal microbiota transplantation

PROCEDURE

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RECRUITINGPHASE2

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Controlled Study on Regulation of Systemic Inflammation by Fecal Bacteria Transplantation in Patients With COVID-19.

Inclusion Criteria

Exclusion Criteria

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