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

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.

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Key information

Conditions

Fecal Microbiota Transplantation COVID-19 COVID-19 Infection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Li Long

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Over 60 years old, male or female;

Meet the diagnostic criteria of COVID-19;

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;

The patient was able to swallow 3# capsules by herself.

Exclusion criteria

1. Confirmed diagnosis of non-COVID19 pneumonia;

Critically ill patients requiring mechanical ventilation, or patients who are unable to eat by mouth and swallow 3# capsules;

Patients who had undergone gastrointestinal surgery;

Presence of intestinal organic lesions such as congenital megacolon, intestinal obstruction, intussusception, etc.

Pathological intestinal inflammatory changes, such as inflammatory bowel disease;

Planned use of antacids, probiotics, antibiotics, FMT and other treatments affecting intestinal flora within the past 3 months or the following 2 months;

Patients and their families did not agree to receive FMT treatment;

Patients unable to cooperate with follow-up visits.

Treatment and study plan

Fecal Microbiota Transplantation

Procedure

Fecal microbiota transplantation (FMT) is the use of functional microorganisms in the feces of healthy people to form capsules and orally administer them to the intestinal tract of patients to reconstruct the intestinal flora of patients, so as to achieve the purpose of treating intestinal and exenteric diseases.

Primary outcomes

Changes of inflammatory factors in the two groups

Time frame: 7day,1month

The changes of inflammatory factors in the transplantation group were detected compared with the control group

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: May 24, 2023
Registry last updated: Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed