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

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05612087
Collaborator
(none)
40
1
13.7
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Confocal laser endomicroscopy

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Clinical Significance of Gut Permeability in Gastrointestinal Post Acute COVID-19
Actual Study Start Date :
Nov 8, 2022
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
gastrointestinal post acute COVID-19 syndrome

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

Device: Confocal laser endomicroscopy
Confocal laser endomicroscopy at jejunum, duodenum and stomach

Outcome Measures

Primary Outcome Measures

  1. gut permeability [3 months]

    leakage under Confocal laser endomicroscopy

Secondary Outcome Measures

  1. gut microbiome [3 months]

    fecal microbiome

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital Taipei Taiwan 112

Sponsors and Collaborators

  • Taipei Veterans General Hospital, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT05612087
Other Study ID Numbers:
  • 2022-09-010C
First Posted:
Nov 10, 2022
Last Update Posted:
Nov 10, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Taipei Veterans General Hospital, Taiwan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2022