Clinical trial NCT02085889: Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders
Official title: Fructose and Lactose Intolerance and Malabsorption: the Relationship Between Metabolism and Symptoms in Functional Gastrointestinal Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Gastrointestinal Disorders
Lactose Intolerance
Fructose Intolerance
Lead sponsor: Brain-Gut Research Group
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Successive patients referred to our gastroenterology practice with functional GI disorders according to ROME 3 criteria.

Brief summary: Background: The association of fructose and lactose intolerance and malabsorption with the symptoms of different functional gastrointestinal disorders (FGID) is unclear. The mechanisms behind the multi-organ symptoms remain unclear. Both FGID and saccharide intolerances are common (\>10% of any given population). Dietary modification based on intolerance diagnostics could provide an effective treatment for FGID, which are otherwise difficult to treat.

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.


Eligibility criteria: Inclusion criteria:

* Patients with functional GI disorders according to ROME 3 criteria
* Without evidence of organic disease by standardised testing in GI practice.

Exclusion criteria:

* Current or relevant history of organic disease.

Primary outcomes:
measure: Number with adequate symptom relief
timeFrame: 6-12 weeks
Secondary outcomes:
measure: Association between adequate symptom relief and test variables
timeFrame: 6-12 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Gastoenterology Group Practice
Study officials:
affiliation: Brain-Gut Research Group
name: Clive Wilder-Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.