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Trial record 7 of 10 for:    "hereditary fructose intolerance" OR "Fructose Metabolism, Inborn Errors" OR "Fructose Intolerance"

Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders

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ClinicalTrials.gov Identifier: NCT02085889
Recruitment Status : Active, not recruiting
First Posted : March 13, 2014
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
C. Wilder-Smith, Brain-Gut Research Group

March 10, 2014
March 13, 2014
July 28, 2015
March 2014
December 2018   (Final data collection date for primary outcome measure)
Number with adequate symptom relief [ Time Frame: 6-12 weeks ]
adequate symptom relief in response to reduction of fermentable sugars
Same as current
Complete list of historical versions of study NCT02085889 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders
Fructose and Lactose Intolerance and Malabsorption: the Relationship Between Metabolism and Symptoms in Functional Gastrointestinal Disorders

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
blood, urine and stool
Probability Sample
Successive patients referred to our gastroenterology practice with functional GI disorders according to ROME 3 criteria.
  • Functional Gastrointestinal Disorders
  • Lactose Intolerance
  • Fructose Intolerance
Other: no intervention: observational study
food intolerance
lactose intolerance fructose intolerance neither intolerance
Intervention: Other: no intervention: observational study

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
Same as current
June 2019
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT02085889
BGRG-2415b
No
Not Provided
Not Provided
C. Wilder-Smith, Brain-Gut Research Group
Brain-Gut Research Group
Not Provided
Principal Investigator: Clive Wilder-Smith, MD Brain-Gut Research Group
Brain-Gut Research Group
July 2015