Fecal Microbiota TransplantationNCT05873348
A Controlled Study on Regulation of Systemic Inflammation by Fecal Bacteria Transplantation in Patients With COVID-19.
A study testing Fecal microbiota transplantation in people with Fecal Microbiota Transplantation and COVID-19 Infection, run by Shanghai 10th People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Fecal Microbiota Transplantation, COVID-19 Infection
- What is being tested?
- Fecal microbiota transplantation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2023to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Fecal microbiota transplantation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| FMTgroup | Experimental | Not described Receives: Procedure: Fecal microbiota transplantation |
| control gtoup | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of inflammatory factors in the two groups
The changes of inflammatory factors in the transplantation group were detected compared with the control group
Measured: 7day,1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start10 Jan 2023
- Primary completion10 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Microbiota TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanlong Qin, Shanghai 10th People's Hospital
- Investigators
- Long Li, Principal investigator, Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873348
- Sponsor's protocol ID
- FMT-COVID-19-230207
- Status last verified
- Jan 2024
- First submitted
- 23 May 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study on Regulation of Systemic Inflammation by Fecal Bacteria Transplantation in Patients With COVID-19.
- ClinicalTrials.gov ID
- NCT05873348
- Acronym / sponsor ID
- FMT-COVID-19-230207
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMTgroup | Experimental | Procedure: Fecal microbiota transplantation |
| control gtoup | No intervention | – |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantationFecal 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. | Procedure or surgery | FMTgroup |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Long Li principal investigator
Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation in people with Fecal Microbiota Transplantation and COVID-19 Infection, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of inflammatory factors in the two groups (time frame: 7day,1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.