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

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-3h5fr2s
• Date of registration: 22/02/2021
• Prospective Registration: No
• Primary sponsor: Faculdade de Medicina da Universidade de São Paulo
• Public title: Gastrointestinal symptoms (such as nausea, vomiting, constipation, diarrhea) and nutrient supplementation in patients with COVID-19
• Scientific title: Characterization and prognostic value of gastrointestinal manifestations and oral nutritional supplementation for caloric-protein adequacy in patients hospitalized with COVID-19
• Date of first enrolment: 25/07/2020
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-3h5fr2s
• Study type: Intervention
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Dan Linetzky Waitzberg

• Name: Alfredo José Mansur

Key inclusion & exclusion criteria

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

Age minimum: 18M
Age maximum: 90Y
Gender: -

Health Condition(s) or Problem(s) studied

Coronavirus Infections Signs and Symptoms, Digestive Protein-Energy Malnutrition

Intervention(s)

At the hospital admission, all COVID-19 patients included (n = 370) were analyzed descriptively regarding their age, sex, race, weight, height, body mass index (BMI), presence of previous comorbidities (diabetes mellitus, obesity, systemic arterial hypertension , cancer, transplant and / or cardiovascular, pulmonary, renal, hepatic, intestinal and HIV / AIDS), presence of respiratory signs and symptoms (dyspnoea and cough), presence of sore throat, presence of gastrointestinal signs and symptoms (diarrhea, constipation, nausea, vomiting, dysgeusia, anorexia, anosmia and abdominal pain), goal of caloric-protein intake, presence of complications associated with COVID-19 (acute renal failure, acute liver failure, acute respiratory failure and / or delirium), type medication prescribed by the medical team (antibiotic, antiviral, anticoagulant, corticoid, analgesic, and antiemetic) and results of biochemical tests requested by the patient's medical team (gly ose, C-reactive protein, sodium, potassium, phosphorus, magnesium, leukocytes, lymphocytes, platelets, d-dimer, albumin, alanine aminotransferase, aspartate aminotransferase, prothrombin time and their normalized international index). Daily, immediately after admission to hospital discharge, they were also monitored for compliance with the caloric-protein goal or not. The type of clinical outcome (hospital discharge, referral to the ICU, palliative treatment or death) was also recorded. Among these 370 patients, patients who had a daily food intake of less than 60% of the estimated caloric-protein goal during the 2 consecutive days during their hospital stay (n = 98) were invited to receive up to 2 units (125 mL each) of an oral supplement complete (among vanilla, strawberry, chocolate and cappuccino flavors), with hype

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Primary Outcome(s)

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(s)

Moderate presence of gastrointestinal manifestations, assessed by recording at admission, based on a frequency of gastrointestinal signs and symptoms higher than 35%

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%.

Source(s) of Monetary Support

Hospital de Caridade São Vicente de Paulo

Secondary Sponsor(s)

Hospital Sírio Libanês

Results

• Results available: Yes
• Date Posted: 30/04/2021
• Date Completed: 27/07/2021
• URL: Indisponível