The Clinical Significance of Gut Permeability in Gastrointestinal Post Acute COVID-19 Syndrome

NCT ID: NCT05612087

Last Updated: 2022-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-08

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Post Acute COVID-19 Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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gastrointestinal post acute COVID-19 syndrome

newly developped functional dyspepsia or irritable bowel syndrome after COVID-19 infection

Confocal laser endomicroscopy

Intervention Type DEVICE

Confocal laser endomicroscopy at jejunum, duodenum and stomach

Interventions

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Confocal laser endomicroscopy

Confocal laser endomicroscopy at jejunum, duodenum and stomach

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* persisted gastrointestinal symptoms such as dyspepsia, abdomen pain, diarrhea or constipation 3 months after COVID-19 infection

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Jen Chen, M.D

Role: CONTACT

+88628712121 ext. 7506

Facility Contacts

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Yu-Jen Chen, M.D

Role: primary

886228712121 ext. 7506

Other Identifiers

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2022-09-010C

Identifier Type: -

Identifier Source: org_study_id

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