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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005660
Enrollment
84
Registered
2020-12-03
Start date
2014-07-11
Completion date
Unknown
Last updated
2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : In these two formulations, there were differences in the carbohydrate, protein, and fat ratios, but the difference was not large enough to be meaningful
only the FODMAP contents were significantly different. In other words, the case group was supplied with a low level of FODMAPs (approximately 2.5 to 5 g) and the control group was supplied with a high

Sponsors

Bundang CHA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Korea, Republic of

Contacts

Public ContactEunJoo Bae

Bundang CHA General Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 16, 2026