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
| Type | Name | Description |
|---|---|---|
| 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 |
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.