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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |

Arm | Intervention/treatment |
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No Intervention: COVID-19 patients no dietary administration
Only medication agreed by the hospital committee
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Experimental: COVID-19 patients with dietary administration
Medication agreed by the hospital committee and nutritional supplement.
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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.

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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 |
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.

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
Contact: xavier cortés | 0034962339300 | xacori@gmail.com | |
Contact: Laura Sanchis | 0034962339300 | lausanar@hotmail.com |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 probiotic supplementation GASTEEL PLUS |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |