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Status unknownNCT02085889Updated Mar 30, 2021

Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders

An observational study in Functional Gastrointestinal Disorders, Lactose Intolerance and Fructose Intolerance, sponsored by Brain-Gut Research Group. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-30.

Primary conditionLactose IntoleranceRegistry: Gastrointestinal DiseasesReclassifiedWhy we changed it
Registry
Gastrointestinal Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lactose Intolerance
Why
  1. The study's listed conditions name Lactose Intolerance, a narrower term within Gastrointestinal Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Brain-Gut Research Group · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Functional Gastrointestinal Disorders
  • Lactose Intolerance
  • Fructose Intolerance

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03

In context

Lactose Intolerance Reclassified

53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 70 across 11 observational studies indexed under Lactose Intolerance.

Browse Lactose Intolerance studies →

Lead sponsor

Brain-Gut Research Group is the lead sponsor of 7 studies on the registry; none are open to participants now.

Compared within Lactose Intolerance, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gastrointestinal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  • Current or relevant history of organic disease.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • food intolerance

    lactose intolerance fructose intolerance neither intolerance

    Other: no intervention: observational study

Interventions

  • Otherno intervention: observational study

    observational

06

What researchers measure

Primary outcomes

  1. Number with adequate symptom relief

    adequate symptom relief in response to reduction of fermentable sugars

    Time frame: 6-12 weeks

Secondary outcomes

  1. Association between adequate symptom relief and test variables

    association between demographic, breath test and metabolomic factors and adequate relief due to dietary modification

    Time frame: 6-12 weeks

07

Study locations

1 of 1 sites recruiting
  • Gastoenterology Group Practice
    Bern, Switzerland
    Recruiting
    • Clive Wilder-Smith, MD · Contactinfo@ggp.ch · +41313123737
    • Clive Wilder-Smith, MD · Principal investigator
08

References and documents

Publications

  • 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. PubMed 32955198 ↗
  • 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. PubMed 30009815 ↗
  • 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. PubMed 29881615 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2019 (actual). Primary completion is estimated for Mar 2022, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2014
First posted
Mar 13, 2014
StartActual
Mar 1, 2019
Primary completionEst.
Mar 2022
CompletionEst.
Dec 2022
Last update
Mar 30, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02085889
Lead sponsor
Brain-Gut Research Group
Responsible party
Clive H Wilder-Smith, MD (Principle Investigator, Brain-Gut Research Group) — Principal investigator
First posted
Mar 13, 2014
Start date
Mar 1, 2019
Primary completion
Mar 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Mar 30, 2021

Study contacts

Clive Wilder-Smith, MD
Contact
info@ggp.ch
+41313123737
Clive Wilder-Smith, MD
principal investigator · Brain-Gut Research Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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