Clinical Trial: Fructose Breath-testing in Irritable Bowel Syndrome (IBS)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Assessment of Psychological and Metabolic Responses During Fructose Intolerance Breath Tests in Patients With Functional GI Disorders: Placebo-controlled Breath Testing

Brief Summary:

Background: Breath testing for food intolerances is becoming routine in patients with functional gastrointestinal disorders (FGID). Both FGID and saccharide intolerances (FODMAPs: fermentable oligo-, di-, polysaccharide and polyols, e.g. lactose, fructose, sorbitol) are common (>10% of any given population) and often respond to dietary modification. The breath tests are based on quantification of gas excretion in breath as a sign of malabsorption and symptom provocation, but are likely subject to considerable psychological bias. The role of expectation and other psychological effects on breath testing has not been reported, but is crucial for the validation of these increasingly wide-spread tests with considerable dietary and potentially deleterious consequences. Fructose has been shown to result in short term pro-inflammatory metabolic responses, but these effects have not been studied as underlying causes for intolerance symptoms in fructose intolerant patients with FGID.

Aim: To investigate the psychological component and the short-term metabolic effects of fructose breath testing in patients referred for evaluation of FGID using placebo. Additionally, to assess baseline predictors for a positive breath test result.

Methods: Fructose intolerance (defined by a positive symptom index) and malabsorption (defined by increased breath hydrogen/methane concentrations) will be determined in 30 successive male and female FGID in a single centre using breath-testing. Fructose 35g, given double-blind as well as open, a sweet placebo (cyclamate/saccharine; Assugrin®) and a neutral (still water) placebo given double-blind will be compared in a randomized, cross-over sequence and according to our standardised procedure on four separate study days. Symptoms will be recorded using standardised questionnaires and breath concentr

Detailed Summary:
Sponsor: Brain-Gut Research Group

Current Primary Outcome: Fructose intolerance, as percentage of patients [ Time Frame: 5 hours ]

Defined by symptom scores


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Between-group comparisons of breath test gas concentrations and symptom indices [ Time Frame: 5 hours ]
    Breath gas concentrations and cumulative symptoms experienced during breath testing will be compared between treatment groups
  • Correlations between breath test gas concentrations, symptom indices and metabolite [ Time Frame: 5 hours ]
    Correlations between changes in gas levels, GI symptoms from baseline and changes in metabolites identified by metabolomic analysis in the different treatment and responder groups (i.e intolerance or no intolerance as defined by the standard breath test results). Metabotype and psychological predictors at baseline for intolerance (responder) status during breath testing will be assessed by multiple regression analysis.


Original Secondary Outcome: Same as current

Information By: Brain-Gut Research Group

Dates:
Date Received: November 16, 2015
Date Started: June 2016
Date Completion: December 2017
Last Updated: May 9, 2016
Last Verified: May 2016