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Fructose Breath-testing in Irritable Bowel Syndrome (IBS)

NCT ID: NCT02614313

Last Updated: 2018-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Functional Gastrointestinal Disorders Irritable Bowel Syndrome

Keywords

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Fructose Irritable Bowel Syndrome Breath test Placebo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fructose double-blind

Fructose during breath test, double-blind 35g

Group Type ACTIVE_COMPARATOR

Blinded breath test with fructose

Intervention Type PROCEDURE

Double-blind randomised fructose 35g during breath test

Fructose open

Fructose during breath test, open 35g

Group Type ACTIVE_COMPARATOR

Open breath test with fructose

Intervention Type PROCEDURE

Open randomised fructose 35g during breath test

Sweet placebo double-blind

Assugrin during breath test double-blind

Group Type PLACEBO_COMPARATOR

Breath test with sweet placebo (Assugrin)

Intervention Type PROCEDURE

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

Neutral placebo double-blind

Water during breath test double-blind

Group Type PLACEBO_COMPARATOR

Breath test with neutral placebo (still water)

Intervention Type PROCEDURE

Double-blind randomised breath-testing with neutral placebo

Interventions

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Open breath test with fructose

Open randomised fructose 35g during breath test

Intervention Type PROCEDURE

Breath test with sweet placebo (Assugrin)

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

Intervention Type PROCEDURE

Breath test with neutral placebo (still water)

Double-blind randomised breath-testing with neutral placebo

Intervention Type PROCEDURE

Blinded breath test with fructose

Double-blind randomised fructose 35g during breath test

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New Jersey Medical School

OTHER

Sponsor Role collaborator

National University of Singapore

OTHER

Sponsor Role collaborator

Brain-Gut Research Group

OTHER

Sponsor Role lead

Responsible Party

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C. Wilder-Smith

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gastoenterology Group Practice

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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BGRG FBT-PLA

Identifier Type: -

Identifier Source: org_study_id