Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders

• Conditions: Fructose Intolerance; Functional Gastrointestinal Disorders; Lactose Intolerance

• Registration Number: NCT02085889
• Lead Sponsor: Brain-Gut Research Group

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-13
• Study Start: 2019-03-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-03-30
• Primary Completion: 2022-03
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number with adequate symptom relief	6-12 weeks	adequate symptom relief in response to reduction of fermentable sugars

Secondary Outcome Measures

Name	Time	Method
Association between adequate symptom relief and test variables	6-12 weeks	association between demographic, breath test and metabolomic factors and adequate relief due to dietary modification

Trial Locations

Locations (1)

Gastoenterology Group Practice; 🇨🇭 Bern, Switzerland