Fructose Breath-testing in Irritable Bowel Syndrome (IBS)

B

Brain-Gut Research Group

Status

Completed

Conditions

Irritable Bowel Syndrome
Functional Gastrointestinal Disorders

Treatments

Procedure: Blinded breath test with fructose
Procedure: Open breath test with fructose
Procedure: Breath test with neutral placebo (still water)
Procedure: Breath test with sweet placebo (Assugrin)

Study type

Interventional

Funder types

Other

Identifiers

NCT02614313
BGRG FBT-PLA

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

30 participants in 4 patient groups, including a placebo group

Fructose double-blind
Active Comparator group
Description:
Fructose during breath test, double-blind 35g
Treatment:
Procedure: Blinded breath test with fructose
Fructose open
Active Comparator group
Description:
Fructose during breath test, open 35g
Treatment:
Procedure: Open breath test with fructose
Sweet placebo double-blind
Placebo Comparator group
Description:
Assugrin during breath test double-blind
Treatment:
Procedure: Breath test with sweet placebo (Assugrin)
Neutral placebo double-blind
Placebo Comparator group
Description:
Water during breath test double-blind
Treatment:
Procedure: Breath test with neutral placebo (still water)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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