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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02353689

Enrollment

Registered

2015-02-03

Start date

2013-10-31

Completion date

2014-12-31

Last updated

2015-02-05

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

Conditions

Enteral Nutrition

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 .

Interventions

DIETARY_SUPPLEMENTlow FODMAP

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

DIETARY_SUPPLEMENTmoderate FODMAP

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

DIETARY_SUPPLEMENThigh FODMAP

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
diarrhea	14-day follow-up

Secondary

Measure	Time frame
prealbumin	14-day follow-up
body mass index	14-day follow-up

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026