Functional Gastrointestinal DisordersNCT02085889
Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders
An observational study of Functional Gastrointestinal Disorders and Lactose Intolerance, run by Brain-Gut Research Group at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Gastrointestinal Disorders, Lactose Intolerance, Fructose Intolerance
- How many people
- 3,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2019to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Successive patients referred to our gastroenterology practice with functional GI disorders according to ROME 3 criteria.
Who may be able to join
- Patients with functional GI disorders according to ROME 3 criteria
- Without evidence of organic disease by standardised testing in GI practice.
Who cannot join
- Current or relevant history of organic disease.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Gastoenterology Group Practice
Bern
Clive Wilder-Smith, MD, +41313123737, info@ggp.ch
Clive Wilder-Smith, MD
About this study
Official title: 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.
- Being tested
- no intervention: observational study
- Medical subject headings
- Gastrointestinal Diseases, Lactose Intolerance, Fructose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention: observational studyOther
observational
| Study group | Role | What they receive |
|---|---|---|
| food intolerance | lactose intolerance fructose intolerance neither intolerance Receives: Other: no intervention: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number with adequate symptom relief
adequate symptom relief in response to reduction of fermentable sugars
Measured: 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
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study start1 Mar 2019
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brain-Gut Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clive H Wilder-Smith, MD, Brain-Gut Research Group
- Investigators
- Clive Wilder-Smith, MD, Principal investigator, Brain-Gut Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085889
- Sponsor's protocol ID
- BGRG-2415b
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2014
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
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 32955198Wilder-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 30009815Wilder-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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructose and Lactose Intolerance and Malabsorption: the Relationship Between Metabolism and Symptoms in Functional Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT02085889
- Acronym / sponsor ID
- BGRG-2415b
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Brain-Gut Research GroupUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| food intolerance | – | Other: no intervention: observational studylactose intolerance fructose intolerance neither intolerance |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Successive patients referred to our gastroenterology practice with functional GI disorders according to ROME 3 criteria.
Key inclusion criteria (2 listed)
- Patients with functional GI disorders according to ROME 3 criteria
- Without evidence of organic disease by standardised testing in GI practice.
Key exclusion criteria (1 listed)
- Current or relevant history of organic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention: observational studyobservational | Other | food intolerance |
Primary outcome
Number with adequate symptom relief
Time frame: 6-12 weeks
adequate symptom relief in response to reduction of fermentable sugars
1 secondary outcome
Association between adequate symptom relief and test variables
Time frame: 6-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 32955198Wilder-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.
- Derived from this study: PubMed 30009815Wilder-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.
- Derived from this study: PubMed 29881615Wilder-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clive Wilder-Smith, MD principal investigator
Brain-Gut Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorders and Lactose Intolerance, run by Brain-Gut Research Group at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clive Wilder-Smith, MD (+41313123737, info@ggp.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number with adequate symptom relief (time frame: 6-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02085889, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.