Fructose Breath-testing in Irritable Bowel Syndrome (IBS)

NCT02614313 | Completed

• 1 other identifier: BGRG FBT-PLA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Gastrointestinal Disorders; Irritable Bowel Syndrome

Keywords

Fructose; Irritable Bowel Syndrome; Breath test; Placebo

Outcome Measures

Primary Outcomes (1)

• Fructose intolerance, as percentage of patients

  Defined by symptom scores

  5 hours

Secondary Outcomes (2)

• Between-group comparisons of breath test gas concentrations and symptom indices

  5 hours

• Correlations between breath test gas concentrations, symptom indices and metabolite

  5 hours

Study Arms (4)

Fructose double-blind

ACTIVE COMPARATOR

Fructose during breath test, double-blind 35g

Procedure: Blinded breath test with fructose

Fructose open

ACTIVE COMPARATOR

Fructose during breath test, open 35g

Procedure: Open breath test with fructose

Sweet placebo double-blind

PLACEBO COMPARATOR

Assugrin during breath test double-blind

Procedure: Breath test with sweet placebo (Assugrin)

Neutral placebo double-blind

PLACEBO COMPARATOR

Water during breath test double-blind

Procedure: Breath test with neutral placebo (still water)

Interventions

Open breath test with fructose PROCEDURE

Open randomised fructose 35g during breath test

Fructose open

Breath test with sweet placebo (Assugrin) PROCEDURE

Double-blind randomised breath-testing with sweet placebo (Assugrin)

Sweet placebo double-blind

Breath test with neutral placebo (still water) PROCEDURE

Double-blind randomised breath-testing with neutral placebo

Neutral placebo double-blind

Blinded breath test with fructose PROCEDURE

Double-blind randomised fructose 35g during breath test

Fructose double-blind

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Thirty male or female FGID (Irritable Bowel Syndrome or Functional Dyspepsia according to the Rome III criteria) patients -
• healthy female and male controls
• aged between 18 and 60 years

You may not qualify if:

• Bowel resections, except appendicectomy or cholecystectomy
• Evidence of organic disease
• No medications (excluding antihypertensives, antidepressants and low-dose aspirin), including herbal, from 4 days before the first study day until after breath test
• Coeliac's disease

Sponsors & Collaborators

• Brain-Gut Research Group: lead
• New Jersey Medical School: collaborator
• National University of Singapore: collaborator

Study Sites (1)

Gastoenterology Group Practice

Bern, Switzerland

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome

Interventions

Fructose

Condition Hierarchy (Ancestors)

Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 25, 2015
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 17, 2018

Record last verified: 2018-12

Locations

CH (1)