Changes in Viral Load in COVID-19 After Probiotics
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|ClinicalTrials.gov Identifier: NCT04666116|
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : December 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Dietary Supplement: Dietary supplementation in patients with covid disease admitted to hospital||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, single blind clinical trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Computerized randomization based on a single sequence based on the latest issue in the patient's medical history|
|Official Title:||Changes in Viral Load in Patients With COVID-19 Disease After Dietary Supplementation With Probiotics: A Randomized Clinical Trial|
|Actual Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||February 2021|
No Intervention: COVID-19 patients no dietary administration
Only medication agreed by the hospital committee
Experimental: COVID-19 patients with dietary administration
Medication agreed by the hospital committee and nutritional supplement.
Dietary Supplement: Dietary supplementation in patients with covid disease admitted to hospital
Dietary supplementation in patients with covid disease admitted to hospital
- Viral load during the period of admission to the nasopharyngeal smear. [ Time Frame: 1 year ]The main objective of the study is to evaluate the capacity of the nutritional supplement (immune system enhancer, antioxidant and anti-inflammatory capacity) to decrease the viral load by nasopharyngeal smear in patients admitted for COVID-19 coronavirus disease
- Clinical indicators on admission and every 48 hours thereafter [ Time Frame: 1 year ]non-invasive mechanical ventilation (NIV) intervention, (yes or not)
- Analytical parameters [ Time Frame: 1 year ]IL-6 initial point. (pg/mL)
- Mobility [ Time Frame: 1 year ]Hospital stay (days) and Stay in Intensive Care Unit (days).
- Microbiome analysis in feces [ Time Frame: 1 year ]Generation of a collection of PCRs products individually labelled from the hypervariable region of the 16s rRNA. After QC, each sample will be PCR amplified using a specific combination of primers specially designed and adapted for massive sequencing to capture the hypervariable region V3-V4 of the bacterial 16s rRNA (Klindworth et al. 2013). Sequencing in a illumina Miseq equipment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04666116
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