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

NCT ID: NCT05873348

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2023-04-30

Brief 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.

Conditions

Fecal Microbiota Transplantation; COVID-19 Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FMTgroup

Group Type: EXPERIMENTAL

Fecal microbiota transplantation

Intervention Type: 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.

control gtoup

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Huanlong Qin

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Long Li

Role: PRINCIPAL_INVESTIGATOR

Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University

Locations

Li Long

Shanghai, , China

Countries

China

Other Identifiers

FMT-COVID-19-230207

Identifier Type: -

Identifier Source: org_study_id