SARS-CoV2 Infection, COVID-19, Gut Microbiota, Mucosal Response, ChildrenNCT06503887
COVID-19 and Intestinal Microbiota in Children
An observational study of SARS-CoV2 Infection, COVID-19, Gut Microbiota, Mucosal Response, Children, run by Saint-Joseph University at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection, COVID-19, Gut Microbiota, Mucosal Response, Children
- What is being tested?
- Stool sample collection
- How many people
- 86 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Apr 2022to 25 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- Within age limits
- positive PCR
Who cannot join
- metabolic disorders, hepatic disorders, immunodeficiency, allergy, autoimmune diseases, IBD, food intolerance, antibiotic administration within 3 months, pro and prebiotic administration within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- Stool sample collection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool sample collectionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Infected Children | collection of the stool sample within a week after a positive PCR or antigen test for SARS-CoV-2 Receives: Other: Stool sample collection | |
| recovered | represent the group of children who were infected before the stool collection Receives: Other: Stool sample collection | |
| Controls | children enrolled and stool sample taken before the covid-19 pandemic Receives: Other: Stool sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the gut microbiota in covid-19 children
Quantify and analyse the composition of the gut microbiota if Lebanese infected Children
Measured: june 2024
Secondary outcomes (2)
Effect on covid infection on mucosal barrier
Evaluation of the consequences of the infection on the mucosal barrier
Measured: june 2024
correlation between gut microbiota and mucosal response
examine the correlation between the composition of the gut microbiota and the mucosal response
Measured: september 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Apr 2022
- Primary completion25 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 Infection, COVID-19, Gut Microbiota, Mucosal Response, ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Collaborators
- Université Paris Cité
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503887
- Sponsor's protocol ID
- CEHDF1914
- Status last verified
- Apr 2024
- First submitted
- 11 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2, Intestinal Microbiota and Mucosal Response in Lebanese Children
- ClinicalTrials.gov ID
- NCT06503887
- Acronym / sponsor ID
- CEHDF1914
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Collaborators
- Université Paris Cité
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infected Children | – | Other: Stool sample collectioncollection of the stool sample within a week after a positive PCR or antigen test for SARS-CoV-2 |
| recovered | – | Other: Stool sample collectionrepresent the group of children who were infected before the stool collection |
| Controls | – | Other: Stool sample collectionchildren enrolled and stool sample taken before the covid-19 pandemic |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- Within age limits
- positive PCR
Key exclusion criteria (1 listed)
- metabolic disorders, hepatic disorders, immunodeficiency, allergy, autoimmune diseases, IBD, food intolerance, antibiotic administration within 3 months, pro and prebiotic administration within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool 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 | Other | Controls, Infected Children, recovered |
Primary outcome
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
2 secondary outcomes
Effect on covid infection on mucosal barrier
Time frame: june 2024
correlation between gut microbiota and mucosal response
Time frame: september 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV2 Infection, COVID-19, Gut Microbiota, Mucosal Response, Children, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the gut microbiota in covid-19 children (time frame: june 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.