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Trial record 41 of 250 for:    test AND provocation

Fructose Breath-testing in Irritable Bowel Syndrome (IBS)

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ClinicalTrials.gov Identifier: NCT02614313
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : December 17, 2018
Sponsor:
Collaborators:
New Jersey Medical School
National University, Singapore
Information provided by (Responsible Party):
C. Wilder-Smith, 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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Fructose intolerance, as percentage of patients [ Time Frame: 5 hours ]
    Defined by symptom scores


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Switzerland
Gastoenterology Group Practice
Bern, Switzerland
Sponsors and Collaborators
Brain-Gut Research Group
New Jersey Medical School
National University, Singapore

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Responsible Party: C. Wilder-Smith, Dr., Brain-Gut Research Group
ClinicalTrials.gov Identifier: NCT02614313     History of Changes
Other Study ID Numbers: BGRG FBT-PLA
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

Keywords provided by C. Wilder-Smith, Brain-Gut Research Group:
Fructose
Irritable Bowel Syndrome
Breath test
Placebo

Additional relevant MeSH terms:
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Syndrome
Irritable Bowel Syndrome
Digestive System Diseases
Gastrointestinal Diseases
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases