Functional Gastrointestinal DisordersNCT02614313
Fructose Breath-testing in Irritable Bowel Syndrome (IBS)
A study testing Open breath test with fructose and Blinded breath test with fructose in people with Functional Gastrointestinal Disorders and Irritable Bowel Syndrome, run by Brain-Gut Research Group at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders, Irritable Bowel Syndrome
- What is being tested?
- Open breath test with fructose and Blinded breath test with fructose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Psychological and Metabolic Responses During Fructose Intolerance Breath Tests in Patients With Functional GI Disorders: Placebo-controlled Breath Testing
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.
- Being tested
- Open breath test with fructose, Breath test with sweet placebo (Assugrin), Breath test with neutral placebo (still water), Blinded breath test with fructose
- Keywords
- Fructose, Irritable Bowel Syndrome, Breath test, Placebo
- Medical subject headings
- Gastrointestinal Diseases, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open breath test with fructoseProcedure or surgery
Open randomised fructose 35g during breath test
Breath test with sweet placebo (Assugrin)Procedure or surgery
Double-blind randomised breath-testing with sweet placebo (Assugrin)
Breath test with neutral placebo (still water)Procedure or surgery
Double-blind randomised breath-testing with neutral placebo
Blinded breath test with fructoseProcedure or surgery
Double-blind randomised fructose 35g during breath test
| Study group | Role | What they receive |
|---|---|---|
| Fructose double-blind | Active comparator | Fructose during breath test, double-blind 35g Receives: Procedure: Blinded breath test with fructose |
| Fructose open | Active comparator | Fructose during breath test, open 35g Receives: Procedure: Open breath test with fructose |
| Sweet placebo double-blind | Placebo comparator | Assugrin during breath test double-blind Receives: Procedure: Breath test with sweet placebo (Assugrin) |
| Neutral placebo double-blind | Placebo comparator | Water during breath test double-blind Receives: Procedure: Breath test with neutral placebo (still water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fructose intolerance, as percentage of patients
Defined by symptom scores
Measured: 5 hours
Secondary outcomes (2)
Between-group comparisons of breath test gas concentrations and symptom indices
Breath gas concentrations and cumulative symptoms experienced during breath testing will be compared between treatment groups
Measured: 5 hours
Correlations between breath test gas concentrations, symptom indices and metabolite
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.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startJun 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain-Gut Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Medical School, National University of Singapore
- Responsible party
- Principal investigator, C. Wilder-Smith, Brain-Gut Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614313
- Sponsor's protocol ID
- BGRG FBT-PLA
- Status last verified
- Dec 2018
- First submitted
- 16 Nov 2015
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Psychological and Metabolic Responses During Fructose Intolerance Breath Tests in Patients With Functional GI Disorders: Placebo-controlled Breath Testing
- ClinicalTrials.gov ID
- NCT02614313
- Acronym / sponsor ID
- BGRG FBT-PLA
- Keywords
- Fructose, Irritable Bowel Syndrome, Breath test, Placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brain-Gut Research GroupUniversity, hospital or other
- Collaborators
- New Jersey Medical School, National University of Singapore
- Study start
- Jun 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fructose double-blind | Active comparator | Procedure: Blinded breath test with fructoseFructose during breath test, double-blind 35g |
| Fructose open | Active comparator | Procedure: Open breath test with fructoseFructose during breath test, open 35g |
| Sweet placebo double-blind | Placebo comparator | Procedure: Breath test with sweet placebo (Assugrin)Assugrin during breath test double-blind |
| Neutral placebo double-blind | Placebo comparator | Procedure: Breath test with neutral placebo (still water)Water during breath test double-blind |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open breath test with fructoseOpen randomised fructose 35g during breath test | Procedure or surgery | Fructose open |
| Breath test with sweet placebo (Assugrin)Double-blind randomised breath-testing with sweet placebo (Assugrin) | Procedure or surgery | Sweet placebo double-blind |
| Breath test with neutral placebo (still water)Double-blind randomised breath-testing with neutral placebo | Procedure or surgery | Neutral placebo double-blind |
| Blinded breath test with fructoseDouble-blind randomised fructose 35g during breath test | Procedure or surgery | Fructose double-blind |
Primary outcome
Fructose intolerance, as percentage of patients
Time frame: 5 hours
Defined by symptom scores
2 secondary outcomes
Between-group comparisons of breath test gas concentrations and symptom indices
Time frame: 5 hours
Correlations between breath test gas concentrations, symptom indices and metabolite
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open breath test with fructose and Blinded breath test with fructose in people with Functional Gastrointestinal Disorders and Irritable Bowel Syndrome, run by Brain-Gut Research Group at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fructose intolerance, as percentage of patients (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.