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OpenTrials
Completed

NCT Number: NCT06503887

COVID-19 and Intestinal Microbiota in 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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Analysis of the gut microbiota in covid-19 children

    Time frame: june 2024

    Quantify and analyse the composition of the gut microbiota if Lebanese infected Children

Secondary outcomes

  1. Effect on covid infection on mucosal barrier

    Time frame: june 2024

    Evaluation of the consequences of the infection on the mucosal barrier

  2. correlation between gut microbiota and mucosal response

    Time frame: september 2024

    examine the correlation between the composition of the gut microbiota and the mucosal response

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Collaborators

  • Université Paris Cité

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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