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

NCT05612087 | Unknown

• 1 other identifier: 2022-09-010C
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Post Acute COVID-19 Syndrome

Keywords

post acute COVID-19 syndrome; gut permeability; Confocal laser endomicroscopy

Outcome Measures

Primary Outcomes (1)

• gut permeability

  leakage under Confocal laser endomicroscopy

  3 months

Secondary Outcomes (1)

• gut microbiome

  3 months

Study Arms (1)

gastrointestinal post acute COVID-19 syndrome

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

Device: Confocal laser endomicroscopy

Interventions

Confocal laser endomicroscopy DEVICE

Confocal laser endomicroscopy at jejunum, duodenum and stomach

gastrointestinal post acute COVID-19 syndrome

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

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

Taipei, 112, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

jejunum mucosa

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yu-Jen Chen, M.D

CONTACT

+88628712121; yzchen5@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 10, 2022
• Study Start: November 8, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)