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

COVID-19 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05873348
• Other study ID #: FMT-COVID-19-230207
• Status: Completed
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: January 2024
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 30, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection
• Fecal Microbiota Transplantation
• Inflammation

Intervention

Procedure:
• Fecal microbiota transplantation
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.

Locations

Country	Name	City	State
China	Li Long	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of inflammatory factors in the two groups	The changes of inflammatory factors in the transplantation group were detected compared with the control group	7day,1month