Gastrointestinal Post Acute COVID-19 SyndromeNCT05612087
The Clinical Significance of Gut Permeability in Gastrointestinal Post Acute COVID-19 Syndrome
An observational study of Gastrointestinal Post Acute COVID-19 Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) and the associated coronavirus disease 2019 (COVID-19) have been spreading all around the world for past 3 years. Some of these convalescent individuals experienced long- term sequelae termed 'long COVID', or 'post- acute COVID-19 syndrome'(PACS). Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Gastrointestinal Post Acute COVID-19 Syndrome
- What is being tested?
- Confocal laser endomicroscopy
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Nov 2022to 31 Dec 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: persisted gastrointestinal symptoms such as dyspepsia, abdomen pain, diarrhea or constipation 3 months after COVID-19 infection
Who may be able to join
- persisted gastrointestinal symptoms such as dyspepsia, abdomen pain, diarrhea or constipation 3 months after COVID-19 infection
Who cannot join
- Terminal cancer, surgical history of gastrointestinal tract, acute gastrointestinal tract bleeding, allergy to fluorescein, pregnant or breast feeding, helicobacter pylori infection, major cardiopulmonary disease, liver cirrhosis, end stage renal disease, autoimmune disease, inflammtory bowel disease, small intestinal bacterial overgrowth, celiac disease, type 1 diabetic mellitus, type II diabetic mellitus, gastroenteritis in 3 months, history of irritable bowel syndrome, usage of NSAID, steroid
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital
Taipei, 112
Yu-Jen Chen, M.D, 886228712121 ext. 7506, yzchen5@vghtpe.gov.tw
About this study
Official title: The Clinical Significance of Gut Permeability in Gastrointestinal Post Acute COVID-19
Severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) and the associated coronavirus disease 2019 (COVID-19) have been spreading all around the world for past 3 years. Some of these convalescent individuals experienced long- term sequelae termed 'long COVID', or 'post- acute COVID-19 syndrome'(PACS). Common manifestations are systemic, neuropsychiatric, cardio- respiratory and gastrointestinal [1].
The prevalence of gastrointestinal PACS was 2-5% in different literatures [2][3]. The risk factors of gastrointestinal PACS include anosmia, ageusia, and presence of chronic bowel disease, dyspeptic symptoms and the psychological comorbidity [4]. Previous articles have discussed pathogenesis of PACS, which was associated with increasing serum cytokine level and persisted inflammatory status [5]. Whereas, the influence of chronic inflammation to target organ has not been well studied. Liu et al explored the gut microbiota dynamics in patients with PACS, which revealed higher levels of Ruminococcus gnavus, Bacteroides vulgatus and lower levels of Faecalibacterium prausnitzii [6]. Another article established the association between multisystem inflammatory syndrome in children (MIS-C) and zonulin-dependent loss of gut mucosal barrier [7]. According to previous studies, infectious enteritis may cause subsequent post infectious irritable bowel syndrome [8][9], which was associated with increased gut permeability, T-lymphocyte, Mast cell and proinflammatory cytokine [10][11]. It is reasonable that gastrointestinal PACS might be also associated with dysfunction of gut mucosal barrier.
Confocal laser endomicroscopy (CLE) is a new endoscopic imaging tool that enables visualization of gut mucosa changes. The gut permeability could be accessed by CLE in patient with irritable bowel syndrome [12]. This study aimed to explore the association between gut permeability and gastrointestinal PACS.
- Being tested
- Confocal laser endomicroscopy
- Keywords
- post acute COVID-19 syndrome, gut permeability, Confocal laser endomicroscopy
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal laser endomicroscopyDevice
Confocal laser endomicroscopy at jejunum, duodenum and stomach
| Study group | Role | What they receive |
|---|---|---|
| gastrointestinal post acute COVID-19 syndrome | newly developped functional dyspepsia or irritable bowel syndrome after COVID-19 infection Receives: Device: Confocal laser endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut permeability
leakage under Confocal laser endomicroscopy
Measured: 3 months
Secondary outcomes (1)
gut microbiome
fecal microbiome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start8 Nov 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Post Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612087
- Sponsor's protocol ID
- 2022-09-010C
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Significance of Gut Permeability in Gastrointestinal Post Acute COVID-19
- ClinicalTrials.gov ID
- NCT05612087
- Acronym / sponsor ID
- 2022-09-010C
- Keywords
- post acute COVID-19 syndrome, gut permeability, Confocal laser endomicroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Nov 2022 (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.
Severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) and the associated coronavirus disease 2019 (COVID-19) have been spreading all around the world for past 3 years. Some of these convalescent individuals experienced long- term sequelae termed 'long COVID', or 'post- acute COVID-19 syndrome'(PACS). Common manifestations are systemic, neuropsychiatric, cardio- respiratory and gastrointestinal [1].
The prevalence of gastrointestinal PACS was 2-5% in different literatures [2][3]. The risk factors of gastrointestinal PACS include anosmia, ageusia, and presence of chronic bowel disease, dyspeptic symptoms and the psychological comorbidity [4]. Previous articles have discussed pathogenesis of PACS, which was associated with increasing serum cytokine level and persisted inflammatory status [5]. Whereas, the influence of chronic inflammation to target organ has not been well studied. Liu et al explored the gut microbiota dynamics in patients with PACS, which revealed higher levels of Ruminococcus gnavus, Bacteroides vulgatus and lower levels of Faecalibacterium prausnitzii [6]. Another article established the association between multisystem inflammatory syndrome in children (MIS-C) and zonulin-dependent loss of gut mucosal barrier [7]. According to previous studies, infectious enteritis may cause subsequent post infectious irritable bowel syndrome [8][9], which was associated with increased gut permeability, T-lymphocyte, Mast cell and proinflammatory cytokine [10][11]. It is reasonable that gastrointestinal PACS might be also associated with dysfunction of gut mucosal barrier.
Confocal laser endomicroscopy (CLE) is a new endoscopic imaging tool that enables visualization of gut mucosa changes. The gut permeability could be accessed by CLE in patient with irritable bowel syndrome [12]. This study aimed to explore the association between gut permeability and gastrointestinal PACS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastrointestinal post acute COVID-19 syndrome | – | Device: Confocal laser endomicroscopynewly developped functional dyspepsia or irritable bowel syndrome after COVID-19 infection |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- persisted gastrointestinal symptoms such as dyspepsia, abdomen pain, diarrhea or constipation 3 months after COVID-19 infection
Key inclusion criteria (1 listed)
- persisted gastrointestinal symptoms such as dyspepsia, abdomen pain, diarrhea or constipation 3 months after COVID-19 infection
Key exclusion criteria (1 listed)
- Terminal cancer, surgical history of gastrointestinal tract, acute gastrointestinal tract bleeding, allergy to fluorescein, pregnant or breast feeding, helicobacter pylori infection, major cardiopulmonary disease, liver cirrhosis, end stage renal disease, autoimmune disease, inflammtory bowel disease, small intestinal bacterial overgrowth, celiac disease, type 1 diabetic mellitus, type II diabetic mellitus, gastroenteritis in 3 months, history of irritable bowel syndrome, usage of NSAID, steroid
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 |
|---|---|---|
| Confocal laser endomicroscopyConfocal laser endomicroscopy at jejunum, duodenum and stomach | Device | gastrointestinal post acute COVID-19 syndrome |
Primary outcome
gut permeability
Time frame: 3 months
leakage under Confocal laser endomicroscopy
1 secondary outcome
gut microbiome
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Post Acute COVID-19 Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Nov 2022. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Jen Chen, M.D (+88628712121 ext. 7506, yzchen5@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gut permeability (time frame: 3 months). 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 10 Nov 2022.