Irritable Bowel Syndrome Clinical Trial
Official title:
Assessment of Psychological and Metabolic Responses During Fructose Intolerance Breath Tests in Patients With Functional GI Disorders: Placebo-controlled Breath Testing
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 concentrations of H2 and CH4
will be measured during testing on the four study days. Somatisation and psychological
profiles will be assessed by questionnaires. Blood samples will be obtained before and during
provocation testing to assess short-term responses to fructose loading by metabolomics.
Fructose, blinded and open, and placebo responses will be compared and baseline predictors
for a positive breath tests assessed.
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