Back to resultsTo Explore the Regulatory Effect of Combined Capsule FMT on the Levels of Inflammatory Factors in Peripheral Blood of Patients With COVID-19 During Treatment.
Primary Purpose
Fecal Microbiota Transplantation, COVID-19 Infection
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Microbiota Transplantation
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.
Sites / Locations
- Li Long
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
FMTgroup
control gtoup
Arm Description
Outcomes
Primary Outcome Measures
Changes of inflammatory factors in the two groups
The changes of inflammatory factors in the transplantation group were detected compared with the control group
Secondary Outcome Measures
Full Information
NCT ID
NCT05873348
First Posted
May 23, 2023
Last Updated
May 23, 2023
Sponsor
Shanghai 10th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05873348
Brief Title
To Explore the Regulatory Effect of Combined Capsule FMT on the Levels of Inflammatory Factors in Peripheral Blood of Patients With COVID-19 During Treatment.
Official Title
A Controlled Study on the Regulation of Systemic Inflammation by Intestinal Bacteria Transplantation in Patients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Microbiota Transplantation, COVID-19 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMTgroup
Arm Type
Experimental
Arm Title
control gtoup
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
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 Outcome Measure Information:
Title
Changes of inflammatory factors in the two groups
Description
The changes of inflammatory factors in the transplantation group were detected compared with the control group
Time Frame
7day,1month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long Li
Organizational Affiliation
Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Li Long
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
To Explore the Regulatory Effect of Combined Capsule FMT on the Levels of Inflammatory Factors in Peripheral Blood of Patients With COVID-19 During Treatment.
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