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Effects of a low-FODMAP enteral formula on diarrhea on patients in the intensive care unit

Not Applicable
Completed
Conditions
Diseases of the nervous system
Registration Number
KCT0005660
Lead Sponsor
Bundang CHA General Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
84
Inclusion Criteria

The subjects were adult patients over 18 years of age, who entered the ICU and who were initiated on EN support through standard formulations and not special formulations (such as diabetes/kidney/concentration/high protein formulations). Since the subjects were not conscious enough to provide consent for the study, we explained and obtained the consent from the legal guardians. The patients who were diagnosed with underlying diseases like diabetes, kidney diseases, digestive diseases, and infectious diseases, and were on medication for the related diseases in the last 6 months were excluded. Patients who were being administered proton pump inhibitors (PPI), antibiotics except ß-latamase, antifungal agents, and laxatives were excluded.

Exclusion Criteria

The subjects were adult patients over 18 years of age, who entered the ICU and who were initiated on EN support through standard formulations and not special formulations (such as diabetes/kidney/concentration/high protein formulations). Since the subjects were not conscious enough to provide consent for the study, we explained and obtained the consent from the legal guardians. The patients who were diagnosed with underlying diseases like diabetes, kidney diseases, digestive diseases, and infectious diseases, and were on medication for the related diseases in the last 6 months were excluded. Patients who were being administered proton pump inhibitors (PPI), antibiotics except ß-latamase, antifungal agents, and laxatives were excluded.

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
In relation to GI system evaluation, seven items were investigated such as diarrhea, the presence of vomiting, GRV before the first EN in the morning, the presence of pressure ulcer, abnormal bowel sounds, abdominal distension, and no defecation days
Secondary Outcome Measures
NameTimeMethod
The following data were collected. The information related to general characteristics and conditions included age, sex, height, weight, body mass index (BMI) (kg/m2), the evaluation of the appropriateness of ICU (Simplified Acute Physiology Score II; SAPS II score), diagnostic category, and blood chemistry (total protein, albumin, hemoglobin, hematocrit, total lymphocytes count, blood urea nitrogen, creatinine, liver function test, and blood glucose). The items related to the infusion of EN were the amount of EN supplied per day, total intake per day, total excretion per day, and the date of reaching the final requirement.
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