Fructose Breath-testing in Irritable Bowel Syndrome (IBS)
|ClinicalTrials.gov Identifier: NCT02614313|
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : December 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Functional Gastrointestinal Disorders Irritable Bowel Syndrome||Procedure: Open breath test with fructose Procedure: Breath test with sweet placebo (Assugrin) Procedure: Breath test with neutral placebo (still water) Procedure: Blinded breath test with fructose||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Assessment of Psychological and Metabolic Responses During Fructose Intolerance Breath Tests in Patients With Functional GI Disorders: Placebo-controlled Breath Testing|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
Active Comparator: Fructose double-blind
Fructose during breath test, double-blind 35g
Procedure: Blinded breath test with fructose
Double-blind randomised fructose 35g during breath test
Active Comparator: Fructose open
Fructose during breath test, open 35g
Procedure: Open breath test with fructose
Open randomised fructose 35g during breath test
Placebo Comparator: Sweet placebo double-blind
Assugrin during breath test double-blind
Procedure: Breath test with sweet placebo (Assugrin)
Double-blind randomised breath-testing with sweet placebo (Assugrin)
Placebo Comparator: Neutral placebo double-blind
Water during breath test double-blind
Procedure: Breath test with neutral placebo (still water)
Double-blind randomised breath-testing with neutral placebo
- Fructose intolerance, as percentage of patients [ Time Frame: 5 hours ]Defined by symptom scores
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614313
|Gastoenterology Group Practice|