Gastrointestinal symptoms (such as nausea, vomiting, constipation, diarrhea) and nutrient supplementation in patients with COVID-19

Not Applicable

• Conditions: Coronavirus InfectionsSigns and Symptoms, DigestiveProtein-Energy Malnutrition

• Registration Number: RBR-3h5fr2s
• Lead Sponsor: Faculdade de Medicina da Universidade de São Paulo

Brief Summary

o informations available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-22
• Results First Posted: 2021-04-30
• Study Completion: 2021-07-27
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

18 to 90 years old; both genders; any ethnicity; diagnosis of COVID 19 confirmed by positive PCR swab; nutritional ingestion lower than 60 percent of calorie-protein needs for 2 sequential days to be included in the intervention group

Exclusion Criteria

For general population pregnancy. For intervention group diabetes mellitus II with mandatory use of insulin; dysphagia that prevented swallowing without thickener; supplemental enteral or parenteral nutrition therapy; previous use of complete oral supplement; presence of three liquid bowel movements for two days; allergy or intolerance to some component of the oral supplement; bleeding; multiple organs and systems dysfunction, Sequential Organ Failure Assessment score higher than 11 points; Karnofsky Performance Scale lower than 50 percent, other acute illness, concomitant participation in other ongoing interventionist clinical protocol

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant attenuation of nutritional deficits influenced by gastrointestinal symptoms by oral nutritional supplementation, assessed from the meet of energy-protein needs, from the observation of an increase of at least 25% in the pre and post-intervention measures.

Secondary Outcome Measures

Name	Time	Method
Good adherence to oral nutritional supplementation, assessed by the frequency of acceptance of the nutritional supplement offered, based on the finding of a rejection lower than 15%. ;Moderate presence of gastrointestinal manifestations, assessed by recording at admission, based on a frequency of gastrointestinal signs and symptoms higher than 35%