Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders
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|ClinicalTrials.gov Identifier: NCT02085889|
Recruitment Status : Active, not recruiting
First Posted : March 13, 2014
Last Update Posted : July 28, 2015
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.
|Condition or disease||Intervention/treatment|
|Functional Gastrointestinal Disorders Lactose Intolerance Fructose Intolerance||Other: no intervention: observational study|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Fructose and Lactose Intolerance and Malabsorption: the Relationship Between Metabolism and Symptoms in Functional Gastrointestinal Disorders|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
U.S. FDA Resources
lactose intolerance fructose intolerance neither intolerance
|Other: no intervention: observational study|
- Number with adequate symptom relief [ Time Frame: 6-12 weeks ]adequate symptom relief in response to reduction of fermentable sugars
- Association between adequate symptom relief and test variables [ Time Frame: 6-12 weeks ]association between demographic, breath test and metabolomic factors and adequate relief due to dietary modification
Biospecimen Retention: Samples Without DNA
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): NCT02085889
|Gastoenterology Group Practice|
|Principal Investigator:||Clive Wilder-Smith, MD||Brain-Gut Research Group|