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Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders

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ClinicalTrials.gov Identifier: NCT02085889
Recruitment Status : Recruiting
First Posted : March 13, 2014
Last Update Posted : March 30, 2021
Information provided by (Responsible Party):
Clive H Wilder-Smith, MD, 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.

Condition or disease Intervention/treatment
Functional Gastrointestinal Disorders Lactose Intolerance Fructose Intolerance Other: no intervention: observational study

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fructose and Lactose Intolerance and Malabsorption: the Relationship Between Metabolism and Symptoms in Functional Gastrointestinal Disorders
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Group/Cohort Intervention/treatment
food intolerance
lactose intolerance fructose intolerance neither intolerance
Other: no intervention: observational study

Primary Outcome Measures :
  1. Number with adequate symptom relief [ Time Frame: 6-12 weeks ]
    adequate symptom relief in response to reduction of fermentable sugars

Secondary Outcome Measures :
  1. 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
blood, urine and stool

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Successive patients referred to our gastroenterology practice with functional GI disorders according to ROME 3 criteria.

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.

Information from the National Library of Medicine

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

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Contact: Clive Wilder-Smith, MD +41313123737 info@ggp.ch

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Gastoenterology Group Practice Recruiting
Bern, Switzerland
Contact: Clive Wilder-Smith, MD    +41313123737    info@ggp.ch   
Principal Investigator: Clive Wilder-Smith, MD         
Sponsors and Collaborators
Brain-Gut Research Group
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Principal Investigator: Clive Wilder-Smith, MD Brain-Gut Research Group
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clive H Wilder-Smith, MD, Principle Investigator, Brain-Gut Research Group
ClinicalTrials.gov Identifier: NCT02085889    
Other Study ID Numbers: BGRG-2415b
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Lactose Intolerance
Fructose Intolerance
Intestinal Diseases
Metabolic Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Fructose Metabolism, Inborn Errors