Clinical Trials Directory

Trials / Completed

CompletedNCT06503887

COVID-19 and Intestinal Microbiota in Children

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

Status
Completed
Phase
Study type
Observational
Enrollment
86 (actual)
Sponsor
Saint-Joseph University · Academic / Other
Sex
All
Age
1 Month – 12 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERStool sample collectionFollowing 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

Timeline

Start date
2022-04-01
Primary completion
2023-09-25
Completion
2023-09-25
First posted
2024-07-16
Last updated
2024-07-16

Locations

1 site across 1 country: Lebanon

Source: ClinicalTrials.gov record NCT06503887. Inclusion in this directory is not an endorsement.