COVID-19 and Intestinal Microbiota in Children

Completed

• Conditions: SARS-CoV2 Infection, COVID-19, Gut Microbiota, Mucosal Response, Children
• Interventions: Other: Stool sample collection

• Registration Number: NCT06503887
• Lead Sponsor: Saint-Joseph University

Brief Summary

SARS-CoV-2 is the causative agent of the COVID-19 pandemic. It appears to cause only mild to moderate upper respiratory symptoms in children, in addition to gastrointestinal symptoms resulting from its penetration into intestinal cells. Viral respiratory infections are often accompanied by a change in the composition of the gut microbiota (GM). Additionally, intestinal metabolites and integrity appear to be altered. This work aims to study the composition of the GM of Lebanese children, currently (n=14) and previously (n=33) infected with SARS-CoV-2 and to compare it to pre-pandemic controls (n=39). Furthermore, the correlation between the composition of the GM and the intestinal homeostasis are evaluated. Clinical data and stool samples were collected from children aged 1 month to 12 years. The bacterial profile is determined by quantitative PCR and 16S rRNA sequencing. Levels of secretory immunoglobulin A (sIgA), fecal calprotectin, beta defensin type 2 (hBD-2), short-chain fatty acids (SCFAs), tryptophan derivatives, and bile acids are also evaluated. Given the well-established relationship between the GM and the immune system, the results of this study could serve as a potential basis for the implementation of personalized nutrition and biotic supplementations aimed at restoring the host-microbiota symbiosis, pointing to the prevention and treatment of COVID-19

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2023-09-25
• Study Completion: 2023-09-25
• Status Verified: 2024-04
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Within age limits
• positive PCR

Exclusion Criteria

• metabolic disorders, hepatic disorders, immunodeficiency, allergy, autoimmune diseases, IBD, food intolerance, antibiotic administration within 3 months, pro and prebiotic administration within 3 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
recovered	Stool sample collection	represent the group of children who were infected before the stool collection
Infected Children	Stool sample collection	collection of the stool sample within a week after a positive PCR or antigen test for SARS-CoV-2
Controls	Stool sample collection	children enrolled and stool sample taken before the covid-19 pandemic

Primary Outcome Measures

Name	Time	Method
Analysis of the gut microbiota in covid-19 children	june 2024	Quantify and analyse the composition of the gut microbiota if Lebanese infected Children

Secondary Outcome Measures

Name	Time	Method
Effect on covid infection on mucosal barrier	june 2024	Evaluation of the consequences of the infection on the mucosal barrier
correlation between gut microbiota and mucosal response	september 2024	examine the correlation between the composition of the gut microbiota and the mucosal response

Trial Locations

Locations (1)

Saint Joseph university; 🇱🇧 Beirut, Lebanon