Clinical Trial: Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Fructose and Lactose Intolerance and Malabsorption: the Relationship Between Metabolism and Symptoms in Functional Gastrointestinal Disorders

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.


Detailed Summary:
Sponsor: Brain-Gut Research Group

Current Primary Outcome: Number with adequate symptom relief [ Time Frame: 6-12 weeks ]

adequate symptom relief in response to reduction of fermentable sugars


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: Brain-Gut Research Group

Dates:
Date Received: March 10, 2014
Date Started: March 2014
Date Completion: June 2019
Last Updated: July 27, 2015
Last Verified: July 2015