NCT05873348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

May 23, 2023

Last Update Submit

January 10, 2024

Conditions

Fecal Microbiota TransplantationCOVID-19 Infection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

FMTgroup

EXPERIMENTAL
Procedure: Fecal microbiota transplantation

control gtoup

NO INTERVENTION

Interventions

Fecal microbiota transplantationPROCEDURE

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.

FMTgroup

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Li Long

Shanghai, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Long Li

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

May 23, 2023

First Posted

May 24, 2023

Study Start

January 10, 2023

Primary Completion

March 10, 2023

Study Completion

April 30, 2023

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations

CN(1)