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Completed

NCT Number: NCT02353689

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

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.

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Key information

Conditions

Enteral Nutrition

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low FODMAP

Dietary Supplement

consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention

moderate FODMAP

Dietary Supplement

consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention

high FODMAP

Dietary Supplement

consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention

Primary outcomes

  1. diarrhea

    Time frame: 14-day follow-up

Secondary outcomes

  1. prealbumin

    Time frame: 14-day follow-up

  2. body mass index

    Time frame: 14-day follow-up

Sponsors and collaborators

Lead sponsor

Oh Yoen Kim

Other

Collaborators

  • Dong-A University

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2015
Registry last updated
Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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