NCT04666116

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

8 months

First QC Date

April 25, 2020

Last Update Submit

December 11, 2020

Conditions

COVID-19

Keywords

COVID-19probiotic supplementationGASTEEL PLUS

Outcome Measures

Primary Outcomes (1)

  • Viral load during the period of admission to the nasopharyngeal smear.

    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

    1 year

Secondary Outcomes (4)

  • Clinical indicators on admission and every 48 hours thereafter

    1 year

  • Analytical parameters

    1 year

  • Mobility

    1 year

  • Microbiome analysis in feces

    1 year

Study Arms (2)

COVID-19 patients no dietary administration

NO INTERVENTION

Only medication agreed by the hospital committee

COVID-19 patients with dietary administration

EXPERIMENTAL

Medication agreed by the hospital committee and nutritional supplement.

Dietary Supplement: Dietary supplementation in patients with covid disease admitted to hospital

Interventions

Dietary supplementation in patients with covid disease admitted to hospitalDIETARY_SUPPLEMENT

Dietary supplementation in patients with covid disease admitted to hospital

COVID-19 patients with dietary administration

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

COMPLETED

Hospital de Sagunto

Valencia, 46520, Spain

RECRUITING

Related Publications (1)

  • Reino-Gelardo S, Palop-Cervera M, Aparisi-Valero N, Espinosa-San Miguel I, Lozano-Rodriguez N, Llop-Furquet G, Sanchis-Artero L, Cortes-Castell E, Rizo-Baeza M, Cortes-Rizo X. Effect of an Immune-Boosting, Antioxidant and Anti-Inflammatory Food Supplement in Hospitalized COVID-19 Patients: A Prospective Randomized Pilot Study. Nutrients. 2023 Apr 1;15(7):1736. doi: 10.3390/nu15071736.

    PMID: 37049576DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

xavier cortés

CONTACT

0034962339300xacori@gmail.com

Laura Sanchis

CONTACT

0034962339300lausanar@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Computerized randomization based on a single sequence based on the latest issue in the patient's medical history
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, single blind clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Digestive specialist from the Internal Medicine Service

Study Record Dates

First Submitted

April 25, 2020

First Posted

December 14, 2020

Study Start

April 1, 2020

Primary Completion

December 1, 2020

Study Completion

February 1, 2021

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations

ES(2)