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

Recruiting

• Conditions: Gastrointestinal Post Acute COVID-19 Syndrome
• Interventions: Device: Confocal laser endomicroscopy

• Registration Number: NCT05612087
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief 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). 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

Not available

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-08
• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Study First Posted: 2022-11-10
• Last Update Posted: 2022-11-10
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
gastrointestinal post acute COVID-19 syndrome	Confocal laser endomicroscopy	newly developped functional dyspepsia or irritable bowel syndrome after COVID-19 infection

Primary Outcome Measures

Name	Time	Method
gut permeability	3 months	leakage under Confocal laser endomicroscopy

Secondary Outcome Measures

Name	Time	Method
gut microbiome	3 months	fecal microbiome

Trial Locations

Locations (1)

Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan