Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders

NCT02085889 | Unknown

• 1 other identifier: BGRG-2415b
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Gastrointestinal Disorders; Lactose Intolerance; Fructose Intolerance

Outcome Measures

Primary Outcomes (1)

• Number with adequate symptom relief

  adequate symptom relief in response to reduction of fermentable sugars

  6-12 weeks

Secondary Outcomes (1)

• Association between adequate symptom relief and test variables

  6-12 weeks

Study Arms (1)

food intolerance

lactose intolerance fructose intolerance neither intolerance

Other: no intervention: observational study

Interventions

no intervention: observational study OTHER

observational

food intolerance

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Successive patients referred to our gastroenterology practice with functional GI disorders according to ROME 3 criteria.

You may qualify if:

• Patients with functional GI disorders according to ROME 3 criteria
• Without evidence of organic disease by standardised testing in GI practice.

You may not qualify if:

• Current or relevant history of organic disease.

Sponsors & Collaborators

• Brain-Gut Research Group: lead

Study Sites (1)

Gastoenterology Group Practice

Bern, Switzerland

RECRUITING

Related Publications (3)

• Wilder-Smith CH, Drewes AM, Materna A, Olesen SS. Extragastrointestinal Symptoms and Sensory Responses During Breath Tests Distinguish Patients With Functional Gastrointestinal Disorders. Clin Transl Gastroenterol. 2020 Aug;11(8):e00192. doi: 10.14309/ctg.0000000000000192.

  PMID: 32955198 DERIVED

• Wilder-Smith CH, Olesen SS, Materna A, Drewes AM. Fermentable Sugar Ingestion, Gas Production, and Gastrointestinal and Central Nervous System Symptoms in Patients With Functional Disorders. Gastroenterology. 2018 Oct;155(4):1034-1044.e6. doi: 10.1053/j.gastro.2018.07.013. Epub 2018 Sep 3.

  PMID: 30009815 DERIVED

• Wilder-Smith CH, Olesen SS, Materna A, Drewes AM. Breath methane concentrations and markers of obesity in patients with functional gastrointestinal disorders. United European Gastroenterol J. 2018 May;6(4):595-603. doi: 10.1177/2050640617744457. Epub 2017 Nov 15.

  PMID: 29881615 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urine and stool

MeSH Terms

Conditions

Gastrointestinal Diseases; Lactose Intolerance; Fructose Intolerance

Condition Hierarchy (Ancestors)

Digestive System Diseases; Malabsorption Syndromes; Intestinal Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Fructose Metabolism, Inborn Errors

Study Officials

• Clive Wilder-Smith, MD

  Brain-Gut Research Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clive Wilder-Smith, MD

CONTACT

+41313123737; info@ggp.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 13, 2014
• Study Start: March 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

CH (1)