Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders
NCT ID: NCT02085889
Last Updated: 2021-03-30
Study Results
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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UNKNOWN
3000 participants
OBSERVATIONAL
2019-03-01
2022-12-31
Brief Summary
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Aim: To investigate the prevalence and interrelationships of fructose and lactose intolerance (symptom induction) and malabsorption (breath test gas production) and their association with clinical GI as well as non-GI symptoms in FGID and the outcome of standard dietary intervention. Mechanisms related to symptom genesis will be investigated using metabolomic analysis of plasma and urine by gas chromatography/time-of-flight mass spectrometry (GC/TOFMS).
Methods: Fructose and lactose intolerance (defined by positive symptom index) and malabsorption (defined by increased hydrogen/methane) will be determined in successive male and female FGID patients in a single center using breath-testing. Symptoms will be recorded using standardised questionnaires and the Rome III criteria. The prevalence of the intolerances in the different FGID subgroups and the associations between breath testing results, clinical symptoms and the outcome of dietary modification will be assessed. Factors predictive of the outcome of dietary modulation will be screened for. GC/TOFMS will be used to assess the human and microbial metabolome in urine and plasma.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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food intolerance
lactose intolerance fructose intolerance neither intolerance
no intervention: observational study
observational
Interventions
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no intervention: observational study
observational
Eligibility Criteria
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Inclusion Criteria
* Without evidence of organic disease by standardised testing in GI practice.
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Brain-Gut Research Group
OTHER
Responsible Party
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Clive H Wilder-Smith, MD
Principle Investigator
Principal Investigators
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Clive Wilder-Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Brain-Gut Research Group
Locations
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Gastoenterology Group Practice
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Wilder-Smith CH, Drewes AM, Materna A, Olesen SS. Extragastrointestinal Symptoms and Sensory Responses During Breath Tests Distinguish Patients With Functional Gastrointestinal Disorders. Clin Transl Gastroenterol. 2020 Aug;11(8):e00192. doi: 10.14309/ctg.0000000000000192.
Wilder-Smith CH, Olesen SS, Materna A, Drewes AM. Fermentable Sugar Ingestion, Gas Production, and Gastrointestinal and Central Nervous System Symptoms in Patients With Functional Disorders. Gastroenterology. 2018 Oct;155(4):1034-1044.e6. doi: 10.1053/j.gastro.2018.07.013. Epub 2018 Sep 3.
Wilder-Smith CH, Olesen SS, Materna A, Drewes AM. Breath methane concentrations and markers of obesity in patients with functional gastrointestinal disorders. United European Gastroenterol J. 2018 May;6(4):595-603. doi: 10.1177/2050640617744457. Epub 2017 Nov 15.
Other Identifiers
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BGRG-2415b
Identifier Type: -
Identifier Source: org_study_id
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