Trial record 6 of 18 for:    "Lactose Intolerance" OR "lactose intolerance"

Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
C. Wilder-Smith, Brain-Gut Research Group
ClinicalTrials.gov Identifier:
NCT02085889
First received: March 10, 2014
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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 Intervention
Functional Gastrointestinal Disorders
Lactose Intolerance
Fructose Intolerance
Other: no intervention: observational study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fructose and Lactose Intolerance and Malabsorption: the Relationship Between Metabolism and Symptoms in Functional Gastrointestinal Disorders

Resource links provided by NLM:


Further study details as provided by Brain-Gut Research Group:

Primary Outcome Measures:
  • Number with adequate symptom relief [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]
    adequate symptom relief in response to reduction of fermentable sugars


Secondary Outcome Measures:
  • Association between adequate symptom relief and test variables [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]
    association between demographic, breath test and metabolomic factors and adequate relief due to dietary modification


Biospecimen Retention:   Samples Without DNA

blood, urine and stool


Estimated Enrollment: 3000
Study Start Date: March 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
food intolerance
lactose intolerance fructose intolerance neither intolerance
Other: no intervention: observational study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02085889

Locations
Switzerland
Gastoenterology Group Practice
Bern, Switzerland
Sponsors and Collaborators
Brain-Gut Research Group
Investigators
Principal Investigator: Clive Wilder-Smith, MD Brain-Gut Research Group
  More Information

No publications provided

Responsible Party: C. Wilder-Smith, Principle Investigator, Brain-Gut Research Group
ClinicalTrials.gov Identifier: NCT02085889     History of Changes
Other Study ID Numbers: BGRG-2415b
Study First Received: March 10, 2014
Last Updated: March 12, 2014
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Lactose Intolerance
Digestive System Diseases
Gastrointestinal Diseases
Malabsorption Syndromes
Disease
Fructose Intolerance
Intestinal Diseases
Metabolic Diseases
Pathologic Processes
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Fructose Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on September 16, 2014