COVID-19 and Intestinal Microbiota in Children

SARS-CoV-2, Intestinal Microbiota and Mucosal Response in Lebanese Children

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

Study Overview

• Status: Completed
• Conditions: SARS-CoV2 Infection, COVID-19, Gut Microbiota, Mucosal Response, Children
• Intervention / Treatment: Other: Stool sample collection

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Saint Joseph University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

children aged between 1 month and 12 years are enrolled in the study. Sample from the control group were collected before the pandemic (for a previous study).

For the infected and recovered children, a positive PCR test is is required for their enrollment in the study.

All the children are healthy and do not suffer from any disease or comorbidity

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infected Children; collection of the stool sample within a week after a positive PCR or antigen test for SARS-CoV-2	Other: Stool sample collection; Following the approval of the legal guardians, a stool collection container was given to the parents in order to collect the stools. Stools were kept at 4ºC for 24h max, then transported to the laboratory, aliquoted and stored at -80ºC for further analysis
recovered; represent the group of children who were infected before the stool collection	Other: Stool sample collection; Following the approval of the legal guardians, a stool collection container was given to the parents in order to collect the stools. Stools were kept at 4ºC for 24h max, then transported to the laboratory, aliquoted and stored at -80ºC for further analysis
Controls; children enrolled and stool sample taken before the covid-19 pandemic	Other: Stool sample collection; Following the approval of the legal guardians, a stool collection container was given to the parents in order to collect the stools. Stools were kept at 4ºC for 24h max, then transported to the laboratory, aliquoted and stored at -80ºC for further analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of the gut microbiota in covid-19 children	Quantify and analyse the composition of the gut microbiota if Lebanese infected Children	june 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on covid infection on mucosal barrier	Evaluation of the consequences of the infection on the mucosal barrier	june 2024
correlation between gut microbiota and mucosal response	examine the correlation between the composition of the gut microbiota and the mucosal response	september 2024

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Collaborators: Université Paris Cité

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): September 25, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CEHDF1914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No