COVID-19 and Intestinal Microbiota in Children

NCT06503887 | Completed

• 1 other identifier: CEHDF1914
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

SARS-CoV2 Infection, COVID-19, Gut Microbiota, Mucosal Response, Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Effect on covid infection on mucosal barrier

  june 2024

• correlation between gut microbiota and mucosal response

  september 2024

Study Arms (3)

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

recovered

represent the group of children who were infected before the stool collection

Other: Stool sample collection

Controls

children enrolled and stool sample taken before the covid-19 pandemic

Other: Stool sample collection

Interventions

Stool sample collection OTHER

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; Infected Children; recovered

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• Within age limits
• positive PCR

You may not qualify if:

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

Sponsors & Collaborators

• Saint-Joseph University: lead
• Université Paris Cité: collaborator

Study Sites (1)

Saint Joseph university

Beirut, Lebanon

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool sample collection from enrolled children

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 16, 2024
• Study Start: April 1, 2022
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-04

Locations

LE (1)