Fructose Breath-testing in Irritable Bowel Syndrome (IBS)

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Functional Gastrointestinal Disorders
• Interventions: Procedure: Breath test with sweet placebo (Assugrin); Procedure: Breath test with neutral placebo (still water); Procedure: Blinded breath test with fructose; Procedure: Open breath test with fructose

• Registration Number: NCT02614313
• Lead Sponsor: Brain-Gut Research Group

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-25
• Study Start: 2016-06
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-14
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sweet placebo double-blind	Breath test with sweet placebo (Assugrin)	Assugrin during breath test double-blind
Neutral placebo double-blind	Breath test with neutral placebo (still water)	Water during breath test double-blind
Fructose double-blind	Blinded breath test with fructose	Fructose during breath test, double-blind 35g
Fructose open	Open breath test with fructose	Fructose during breath test, open 35g

Primary Outcome Measures

Name	Time	Method
Fructose intolerance, as percentage of patients	5 hours	Defined by symptom scores

Secondary Outcome Measures

Name	Time	Method
Between-group comparisons of breath test gas concentrations and symptom indices	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	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.

Trial Locations

Locations (1)

Gastoenterology Group Practice; 🇨🇭 Bern, Switzerland