Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders
This trial is active, not recruiting.
|Conditions||functional gastrointestinal disorders, lactose intolerance, fructose intolerance|
|Treatment||no intervention: observational study|
|Sponsor||Brain-Gut Research Group|
|Start date||March 2014|
|End date||December 2018|
|Trial size||3000 participants|
|Trial identifier||NCT02085889, BGRG-2415b|
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.
lactose intolerance fructose intolerance neither intolerance
Number with adequate symptom relief
time frame: 6-12 weeks
Association between adequate symptom relief and test variables
time frame: 6-12 weeks
Male or female participants at least 18 years old.
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.
|Official title||Fructose and Lactose Intolerance and Malabsorption: the Relationship Between Metabolism and Symptoms in Functional Gastrointestinal Disorders|
|Principal investigator||Clive Wilder-Smith, MD|
Call for more information