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

Enteral Nutrition Clinical Trial

Official title:

Identification of the Effect of Fermentable Oligo-, di-, and Mono- Saccharides and Poorly Absorbed Short-chain Carbohydrate (FODMAP) Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353689
• Other study ID #: 2-1040709-AB-N-01-201310-BR-03
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 29, 2015
• Last updated: February 4, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Dong-A University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Enteral Nutrition

Intervention

Dietary Supplement:
• low FODMAP
consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention
• moderate FODMAP
consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention
• high FODMAP
consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oh Yoen Kim	Dong-A University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diarrhea		14-day follow-up	Yes
Secondary	prealbumin		14-day follow-up	Yes
Secondary	body mass index		14-day follow-up	Yes