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Changes in Viral Load in COVID-19 After Probiotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04666116
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : December 16, 2020
Sponsor:
Collaborators:
Biopolis S.L.
Laboratorios Heel España
Information provided by (Responsible Party):
Xavier Cortés, Hospital de Sagunto

Brief Summary:
The main objective of the study is to evaluate the capacity of a novel nutritional supplement intervention including strains from the species Bifidobacterium longum, Bifidobacterium animalis subsp. Lactis and Lactobacillus rhamnosus, plus vitamin D, zinc and seleniumt) (immune system enhancer, antioxidant and anti-inflammatory capacity) to decrease the viral load by nasopharyngeal smear in patients admitted for COVID-19 coronavirus disease.

Condition or disease Intervention/treatment Phase
COVID-19 Dietary Supplement: Dietary supplementation in patients with covid disease admitted to hospital Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clinical indicators on admission and every 48 hours thereafter [ Time Frame: 1 year ]
    non-invasive mechanical ventilation (NIV) intervention, (yes or not)

  2. Analytical parameters [ Time Frame: 1 year ]
    IL-6 initial point. (pg/mL)

  3. Mobility [ Time Frame: 1 year ]
    Hospital stay (days) and Stay in Intensive Care Unit (days).

  4. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 18 years of age admitted to the Internal Medicine Unit of Sagunto Hospital, for illness due to infection secondary to COVID-19 during the study period.
  • To be willing and able to sign the informed consent to participate

Exclusion Criteria:

  • Not meeting any of the inclusion criteria.
  • Present allergy to any of the components of the nutritional supplement Gasteel Plus.
  • Not being able to ingest anything by mouth, either by dysphagia or by prescription.

Information from the National Library of Medicine

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


Contacts
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Contact: xavier cortés 0034962339300 xacori@gmail.com
Contact: Laura Sanchis 0034962339300 lausanar@hotmail.com

Locations
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Spain
Hospital de Sagunto Completed
Sagunto, Valencia, Spain, 46520
Hospital de Sagunto Recruiting
Valencia, Spain, 46520
Contact: Xavier Cortés    0034 962 33 93 00    xacori@gmail.com   
Contact: Laura Sanchis    0034 962 33 93 00    lausanar@hotmail.com   
Sponsors and Collaborators
Hospital de Sagunto
Biopolis S.L.
Laboratorios Heel España
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Responsible Party: Xavier Cortés, Digestive specialist from the Internal Medicine Service, Hospital de Sagunto
ClinicalTrials.gov Identifier: NCT04666116    
Other Study ID Numbers: HdeSagunto
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xavier Cortés, Hospital de Sagunto:
COVID-19
probiotic supplementation
GASTEEL PLUS