NCT02353689

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Oh Yoen Kim · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Enteral Nutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	low FODMAP	consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention
DIETARY_SUPPLEMENT	moderate FODMAP	consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention
DIETARY_SUPPLEMENT	high FODMAP	consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2015-02-03
• Last updated: 2015-02-05