The Effect of FODMAP Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement

Phase 2

Completed

• Conditions: Enteral Nutrition

• Registration Number: NCT02353689
• Lead Sponsor: Oh Yoen Kim

Brief Summary

This study aimed to investigate the effects of FODMAP contents in enteral nutrition (EN) formulas on major gastrointestinal intolerance symptoms and nutritional status in tube fed patients through the randomized, double blind and placebo-controlled trial.

Detailed Description

A randomized, double-blind, placebo-controlled study was conducted on 100 tube-fed patients. Over a 14-day test period, the test group consumed EN formula containing low FODMAPs, while the placebo groups consumed EN formula containing moderate or high FODMAPs .

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-01-29
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-03
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• tube-feeding patients

Exclusion Criteria

• EN prohibited
• renal dysfunction (i.e. serum creatinine > 1.5 mg/dl or blood urea nitrogen > 25 mg/ml)
• liver dysfunction (i.e. serum aspartate aminotransferase > 40 U/L or alanine aminotransferase > 40 U/L)
• uncontrollable diabetes mellitus
• pregnancy, breast-feeding etc.
• severe diarrhea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
diarrhea	14-day follow-up

Secondary Outcome Measures

Name	Time	Method
prealbumin	14-day follow-up
body mass index	14-day follow-up