An interventional study of Open breath test with fructose and Breath test with sweet placebo (Assugrin) in Functional Gastrointestinal Disorders and Irritable Bowel Syndrome, sponsored by Brain-Gut Research Group. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-17.
Sponsored by Brain-Gut Research Group · Not applicable, Interventional, and Diagnostic
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.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Brain-Gut Research Group is the lead sponsor of 7 studies on the registry; none are open to participants now.
Compared within Irritable Bowel Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gastrointestinal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion criteria:
Fructose during breath test, double-blind 35g
Procedure: Blinded breath test with fructose
Fructose during breath test, open 35g
Procedure: Open breath test with fructose
Assugrin during breath test double-blind
Procedure: Breath test with sweet placebo (Assugrin)
Water during breath test double-blind
Procedure: Breath test with neutral placebo (still water)
Open randomised fructose 35g during breath test
Double-blind randomised breath-testing with sweet placebo (Assugrin)
Double-blind randomised breath-testing with neutral placebo
Double-blind randomised fructose 35g during breath test
Fructose intolerance, as percentage of patients
Defined by symptom scores
Time frame: 5 hours
Between-group comparisons of breath test gas concentrations and symptom indices
Breath gas concentrations and cumulative symptoms experienced during breath testing will be compared between treatment groups
Time frame: 5 hours
Correlations between breath test gas concentrations, symptom indices and metabolite
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.
Time frame: 5 hours
The record gives a start of Jun 2016, a primary completion of Aug 2017 and a completion of Aug 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Brain-Gut Research Group