Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders

Functional Gastrointestinal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02085889
• Other study ID #: BGRG-2415b
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: December 2022

Study information

• Verified date: March 2021
• Source: Brain-Gut Research Group
• Contact: Clive Wilder-Smith, MD
• Phone: +41313123737
• Email: info[@]ggp.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Fructose Intolerance
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Lactose Intolerance
• Malabsorption Syndromes

Intervention

Other:
• no intervention: observational study
observational

Locations

Country	Name	City	State
Switzerland	Gastoenterology Group Practice	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Brain-Gut Research Group

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number with adequate symptom relief	adequate symptom relief in response to reduction of fermentable sugars	6-12 weeks
Secondary	Association between adequate symptom relief and test variables	association between demographic, breath test and metabolomic factors and adequate relief due to dietary modification	6-12 weeks