Functional Gastrointestinal DisordersPreDiMiNCT03460613
Prevalence of FODMAP Intolerance and JHS in FGID and Association With Microbiome, Dyssynergic Defecation and Dietary Intervention
A study testing FODMAP diet in people with Functional Gastrointestinal Disorders, run by University of Zurich at 1 site in Switzerland.
Trial summary
Irritable bowel syndrome (IBS) is a disorder of gastrointestinal function characterized by abdominal symptoms and pain associated with alterations in bowel habit. The condition impacts on the quality of life of at least 10% of the population, impacts on activities of daily living and is associated with considerable… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- FODMAP diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Jul 2017to 20 Mar 2024
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Functional bowel disease as per physician's diagnosis (medical judgement) and Rome IV criteria
- Signed Informed Consent after being informed
- Age 18-60 years
- Signed Informed Consent after being informed
- Age 18-60 years
- Patient in the ambulatory hepatology clinic
- Signed informed consent after being informed
- Age 18-60 years
Who cannot join
- Inflammatory bowel disease
- Gastrointestinal malignancy
- Celiac Disease
- Known or suspected non-compliance, drug or alcohol abuse
- Previous large abdominal surgery likely to impact patient symptomatology
- Inability to follow the procedures of the study, e.g. due to language problems, dementia, etc. of the participant
Show all 10Show fewer
- Previous enrollment into the current study
- Use of antibiotics in the previous 4 weeks before enrolment
- Previous diagnosed functional gastrointestinal disorders
- Previous diagnosed functional gastrointestinal disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of FODMAP Intolerance and Joint Hypermobility Syndrome in Functional Bowel Patients and Association With Microbiome, Dyssynergic Defecation and Dietary Intervention - a Prospective Cohort Study With Health-related Intervention
Irritable bowel syndrome (IBS) is a disorder of gastrointestinal function characterized by abdominal symptoms and pain associated with alterations in bowel habit. The condition impacts on the quality of life of at least 10% of the population, impacts on activities of daily living and is associated with considerable direct and indirect costs to the individual, the health system and society. The etiology of IBS appears multifactorial and several mechanisms, among them mucosal inflammation, abnormal intestinal motility, visceral hypersensitivity and psychological factors, appear to be involved.
An underlying pathophysiology, namely Joint Hypermobility (JH) and Joint Hypermobility Syndrome (JHS), that we are going to study, have recently gained increasing attention in patients with functional bowel disease.
Read more
One factor which was shown in previous IBS-studies to reduce abdominal symptoms is a FODMAP diet.
To identify FGID patients which profit most from different diagnostics and therapies (such as dietary intervention (FODMAP diet, 2-food-elimination diet)) we are going to carry out a study analyzing different subtypes of FGID (in particular IBS, FD, functional abdominal pain/bloating) for demographics, clinical diagnostics (e.g. nutrient challenge testing, microbiome testing, anorectal manometry and MR defecography), comorbidities (in particular JH, JHS and psychological comorbidities) and treatment.
Read the detailed description
Functional gastrointestinal disorders (FGID) are common in the general population. Symptoms such as pain, nausea, bloating, diarrhea or constipation may occur. Irritable bowel syndrome (IBS) is the most common FGID with a prevalence in the range of 5-25%. Medical attention is sought by 20-75% of patients who meet diagnostic criteria for IBS at some time in their lives. Quality of life is often impaired in IBS patients. In previous studies a diet low in FODMAP was shown to reduce gastrointestinal symptoms in IBS patients.
But still it is unknown which FGID patients (e.g. patients with irritable bowel syndrome, functional dyspepsia (FD), functional abdominal pain/bloating) profit most from such a diet which involves costs, time and significant lifestyle alteration.
To test for food intolerances, standard hydrogen breath tests using fructose or lactose as challenge substance are still commonly used and do present a nutritional challenge, however the usefulness of information gained is questionable. Fructose intolerance is as prevalent in IBS as in healthy volunteers, in fact when tested with the usual doses of 25-50g, prevalence of fructose intolerance ranges between 53% and 73%. Testing (genetic) for hypolactasia, is often, even in the professional setting, misunderstood as lactose intolerance testing. Most patients, who do have hypolactasia, i.e. almost no activity of intestinal brush-border enzyme lactase, tolerate up to 12g of lactose per day, remain asymptomatic and therefore should not be considered lactose intolerant. In addition, one must realize, that the vast majority in the world is hypolactasic and hypolactasia, or rather lactase persistence, constitutes a norm variant.
Recently it was shown that a standardized liquid mixed nutrient meal including 25g lactulose, but not with 15g lactulose, allows differentiation of IBS patients from healthy controls. This test, incorporating FODMAP lactulose, that, unlike lactose and fructose, is indigestible in all humans in the small intestine, plus a caloric load, reflecting a regular meal and everyday life, has therefore the potential to be a useful marker of nutrient intolerance in patients with suspected functional bowel disease.
Additionally, associations between FGID and JH/JHS have been recognized in the past decade. JH/JHS constitutes a hereditary disorder of connective tissue in which patients often report non-musculoskeletal symptoms, among them gastrointestinal complaints. Previous studies in Europe and the U.S. have reported a JHS prevalence of 20% in the general population.
A stringent approach to studying possibly JH and JHS-related changes with diagnostic and interventional arms, such as a nutrient challenge testing or dietary adaptation (i.e.FODMAP diet, 2-food-elimination diet) has not yet been taken.
Differences in the intestinal microbiome have been shown in IBS patients compared to healthy volunteers but not in JHS compared to non-JHS patients. Given the differences noted in patients' symptomatology, the preliminary data on gut function and the underlying structural abnormalities, the role of microbiome in relation to FGID and JHS is highly interesting and, as yet, unstudied. In recent years with the advent of more powerful sequencing tools, a number of studies have been published, that try to characterize the microbiome in IBS patients. Research on IBS-related changes of the microbiome is early and incomplete. The number of literature reviews regarding gut microbiome currently far exceeds the number of original articles reporting on the microbiome in functional bowel disease. IBS-specific interventional studies are even rarer and when performed, often lack control groups and the reality of multiple or repeated intervention, that characterize treatment of FGID. Therefore, and to identify patients according to their microbiome which profit most from therapeutic intervention (such as FODMAP diet, 2-food elimination diet) we are also going to analyze microbiome changes before and after dietary intervention.
Another pathological, impairing aspect of IBS patients is the intestinal hypersensitivity. Anorectal hypersensitivity measurement has been considered a hallmark for IBS for many years. We are routinely performing anorectal functions tests in our specialized unit. Recently we validated high-resolution anorectal manometry and rapid barostat bag measurements to assess visceral sensitivity; in a further study we assessed obstructive defecation when compared to magnetic resonance defecography. In an earlier study employing magnetic resonance defecography (MR defecography) we were able to show that MR defecography, apart from correlating well with the diagnosis of dyssynergic defecation suggested by anorectal manometry, additional pelvic floor abnormalities such as pelvic floor descent, cystocele and enterocele could be identified. Studying these measures in patients with suspected outlet obstruction in relation to JHS status, which is considered a risk factor for pelvic floor abnormalities, might lead to more focused diagnostic and therapeutic approaches in the future for patients who profit most from certain procedures.
Considering all above mentioned facts we are going to carry out a study analyzing different subtypes of FGID (in particular IBS, FD, functional abdominal pain/bloating) for demographics, clinical diagnostics (e.g. nutrient challenge testing, microbiome testing, anorectal manometry and MR defecography), treatment (FODMAP diet) and comorbidities (in particular JH, JHS and psychological comorbidities) to identify FGID patients which profit most from different diagnostics and dietary interventions.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- FODMAP diet
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FODMAP dietOther
Patients with a diagnosed FODMAP intolerance (and a control with no FODMAP intolerance) by prior nutrient challenge testing are going on a FODMAP diet or a 2-food elimination diet (wheat products, milk products excluded).
For the FODMAP diet: In a first nutritional visit a specialized nutritionist will inform the patients about FODMAP containing foods and illustrate a FODMAP elimination diet. After 3 weeks of elimination diet another visit will take place and a stepwise reintroduction diet is initiated after successful elimination diet. For the 2-food elemination diet: In a first nutritional visit a specialized nutritionist will inform the patients about the 2-food-elimination diet (foods containing milk- and wheat products) and illustrate an elimination diet. After 3 weeks of elimination diet another visit will take place and a stepwise reintroduction diet is initiated after successful elimination diet.
| Study group | Role | What they receive |
|---|---|---|
| FGID Patients | Other | Not described Receives: Other: FODMAP diet |
| Hepatology Control Group | No intervention | Not described |
| Healthy Volunteers | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Joint Hypermobility / hypermobile Ehlers-Danlos Syndrome according to the criteria of the "2017 International Classification of the Ehlers-Danlos Syndromes" (hEDS)
Prevalence of joint hypermobility resp. hEDS will be assessed by physicians according to the criteria of the "2017 International Classification of the Ehlers-Danlos Syndromes" in patients with disorders of gut-brain interactions (FGID). The assessment consists of some hypermobility testings (wrists, fingers, elbows, knees and legs) and questions about family hypermobility syndrome history, scars healing, hernia history etc.
Measured: 15 minutes
Secondary outcomes (2)
Prevalence of FODMAP intolerance according to nutrient challenge testing (NCT).
Prevalence of FODMAP intolerance in FGID patients will be assessed according to nutrient challenge testing (NCT). Patients drink a specific beverage containing a specific sugar. The hydrogen value in breath is then measured every 10 minutes and symptoms are recorded at the same time. Depending on the time of hydrogen production and the increase of abdominal symptoms can a FODMAP intolerance be determined.
Measured: 3-4 hours
Response to dietary intervention
FGID patients will be randomized according to the participants JH-status and according to the result of NCT to the dietary intervention. Patients will be randomised to a low FODMAP-diet or 2-food-elimination diet. They will follow a specific intervention diet with guidance of a dietician and the abdominal symptoms will be assessed every 4 weeks approximately.
Measured: 10-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start7 Jul 2017
- Primary completion30 Dec 2023
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Pohl, PD Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460613
- Sponsor's protocol ID
- 2016-01887
- Other IDs
- 2016
- Acronym
- PreDiMi
- Status last verified
- Nov 2025
- First submitted
- 6 Jul 2017
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of FODMAP Intolerance and Joint Hypermobility Syndrome in Functional Bowel Patients and Association With Microbiome, Dyssynergic Defecation and Dietary Intervention - a Prospective Cohort Study With Health-related Intervention
- ClinicalTrials.gov ID
- NCT03460613
- Acronym / sponsor ID
- PreDiMi / 2016-01887
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 9 Mar 2018 (actual)
- 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.
Irritable bowel syndrome (IBS) is a disorder of gastrointestinal function characterized by abdominal symptoms and pain associated with alterations in bowel habit. The condition impacts on the quality of life of at least 10% of the population, impacts on activities of daily living and is associated with considerable direct and indirect costs to the individual, the health system and society. The etiology of IBS appears multifactorial and several mechanisms, among them mucosal inflammation, abnormal intestinal motility, visceral hypersensitivity and psychological factors, appear to be involved.
An underlying pathophysiology, namely Joint Hypermobility (JH) and Joint Hypermobility Syndrome (JHS), that we are going to study, have recently gained increasing attention in patients with functional bowel disease.
One factor which was shown in previous IBS-studies to reduce abdominal symptoms is a FODMAP diet.
To identify FGID patients which profit most from different diagnostics and therapies (such as dietary intervention (FODMAP diet, 2-food-elimination diet)) we are going to carry out a study analyzing different subtypes of FGID (in particular IBS, FD, functional abdominal pain/bloating) for demographics, clinical diagnostics (e.g. nutrient challenge testing, microbiome testing, anorectal manometry and MR defecography), comorbidities (in particular JH, JHS and psychological comorbidities) and treatment.
Detailed description
Functional gastrointestinal disorders (FGID) are common in the general population. Symptoms such as pain, nausea, bloating, diarrhea or constipation may occur. Irritable bowel syndrome (IBS) is the most common FGID with a prevalence in the range of 5-25%. Medical attention is sought by 20-75% of patients who meet diagnostic criteria for IBS at some time in their lives. Quality of life is often impaired in IBS patients. In previous studies a diet low in FODMAP was shown to reduce gastrointestinal symptoms in IBS patients.
But still it is unknown which FGID patients (e.g. patients with irritable bowel syndrome, functional dyspepsia (FD), functional abdominal pain/bloating) profit most from such a diet which involves costs, time and significant lifestyle alteration.
To test for food intolerances, standard hydrogen breath tests using fructose or lactose as challenge substance are still commonly used and do present a nutritional challenge, however the usefulness of information gained is questionable. Fructose intolerance is as prevalent in IBS as in healthy volunteers, in fact when tested with the usual doses of 25-50g, prevalence of fructose intolerance ranges between 53% and 73%. Testing (genetic) for hypolactasia, is often, even in the professional setting, misunderstood as lactose intolerance testing. Most patients, who do have hypolactasia, i.e. almost no activity of intestinal brush-border enzyme lactase, tolerate up to 12g of lactose per day, remain asymptomatic and therefore should not be considered lactose intolerant. In addition, one must realize, that the vast majority in the world is hypolactasic and hypolactasia, or rather lactase persistence, constitutes a norm variant.
Recently it was shown that a standardized liquid mixed nutrient meal including 25g lactulose, but not with 15g lactulose, allows differentiation of IBS patients from healthy controls. This test, incorporating FODMAP lactulose, that, unlike lactose and fructose, is indigestible in all humans in the small intestine, plus a caloric load, reflecting a regular meal and everyday life, has therefore the potential to be a useful marker of nutrient intolerance in patients with suspected functional bowel disease.
Additionally, associations between FGID and JH/JHS have been recognized in the past decade. JH/JHS constitutes a hereditary disorder of connective tissue in which patients often report non-musculoskeletal symptoms, among them gastrointestinal complaints. Previous studies in Europe and the U.S. have reported a JHS prevalence of 20% in the general population.
A stringent approach to studying possibly JH and JHS-related changes with diagnostic and interventional arms, such as a nutrient challenge testing or dietary adaptation (i.e.FODMAP diet, 2-food-elimination diet) has not yet been taken.
Differences in the intestinal microbiome have been shown in IBS patients compared to healthy volunteers but not in JHS compared to non-JHS patients. Given the differences noted in patients' symptomatology, the preliminary data on gut function and the underlying structural abnormalities, the role of microbiome in relation to FGID and JHS is highly interesting and, as yet, unstudied. In recent years with the advent of more powerful sequencing tools, a number of studies have been published, that try to characterize the microbiome in IBS patients. Research on IBS-related changes of the microbiome is early and incomplete. The number of literature reviews regarding gut microbiome currently far exceeds the number of original articles reporting on the microbiome in functional bowel disease. IBS-specific interventional studies are even rarer and when performed, often lack control groups and the reality of multiple or repeated intervention, that characterize treatment of FGID. Therefore, and to identify patients according to their microbiome which profit most from therapeutic intervention (such as FODMAP diet, 2-food elimination diet) we are also going to analyze microbiome changes before and after dietary intervention.
Another pathological, impairing aspect of IBS patients is the intestinal hypersensitivity. Anorectal hypersensitivity measurement has been considered a hallmark for IBS for many years. We are routinely performing anorectal functions tests in our specialized unit. Recently we validated high-resolution anorectal manometry and rapid barostat bag measurements to assess visceral sensitivity; in a further study we assessed obstructive defecation when compared to magnetic resonance defecography. In an earlier study employing magnetic resonance defecography (MR defecography) we were able to show that MR defecography, apart from correlating well with the diagnosis of dyssynergic defecation suggested by anorectal manometry, additional pelvic floor abnormalities such as pelvic floor descent, cystocele and enterocele could be identified. Studying these measures in patients with suspected outlet obstruction in relation to JHS status, which is considered a risk factor for pelvic floor abnormalities, might lead to more focused diagnostic and therapeutic approaches in the future for patients who profit most from certain procedures.
Considering all above mentioned facts we are going to carry out a study analyzing different subtypes of FGID (in particular IBS, FD, functional abdominal pain/bloating) for demographics, clinical diagnostics (e.g. nutrient challenge testing, microbiome testing, anorectal manometry and MR defecography), treatment (FODMAP diet) and comorbidities (in particular JH, JHS and psychological comorbidities) to identify FGID patients which profit most from different diagnostics and dietary interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FGID Patients | Other | Other: FODMAP diet |
| Hepatology Control Group | No intervention | – |
| Healthy Volunteers | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Functional bowel disease as per physician's diagnosis (medical judgement) and Rome IV criteria
- Signed Informed Consent after being informed
- Age 18-60 years
- Signed Informed Consent after being informed
- Age 18-60 years
Key exclusion criteria (10 listed)
- Inflammatory bowel disease
- Gastrointestinal malignancy
- Celiac Disease
- Known or suspected non-compliance, drug or alcohol abuse
- Previous large abdominal surgery likely to impact patient symptomatology
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 |
|---|---|---|
| FODMAP dietPatients with a diagnosed FODMAP intolerance (and a control with no FODMAP intolerance) by prior nutrient challenge testing are going on a FODMAP diet or a 2-food elimination diet (wheat products, milk products excluded). For the FODMAP diet: In a first nutritional visit a specialized nutritionist will inform the patients about FODMAP containing foods and illustrate a FODMAP elimination diet. After 3 weeks of elimination diet another visit will take place and a stepwise reintroduction diet is initiated after successful elimination diet. For the 2-food elemination diet: In a first nutritional visit a specialized nutritionist will inform the patients about the 2-food-elimination diet (foods containing milk- and wheat products) and illustrate an elimination diet. After 3 weeks of elimination diet another visit will take place and a stepwise reintroduction diet is initiated after successful elimination diet. | Other | FGID Patients |
Primary outcome
Prevalence of Joint Hypermobility / hypermobile Ehlers-Danlos Syndrome according to the criteria of the "2017 International Classification of the Ehlers-Danlos Syndromes" (hEDS)
Time frame: 15 minutes
Prevalence of joint hypermobility resp. hEDS will be assessed by physicians according to the criteria of the "2017 International Classification of the Ehlers-Danlos Syndromes" in patients with disorders of gut-brain interactions (FGID). The assessment consists of some hypermobility testings (wrists, fingers, elbows, knees and legs) and questions about family hypermobility syndrome history, scars healing, hernia history etc.
2 secondary outcomes
Prevalence of FODMAP intolerance according to nutrient challenge testing (NCT).
Time frame: 3-4 hours
Response to dietary intervention
Time frame: 10-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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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.
Daniel Pohl, PD Dr. med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FODMAP diet in people with Functional Gastrointestinal Disorders, run by University of Zurich 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 2 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Joint Hypermobility / hypermobile Ehlers-Danlos Syndrome according to the criteria of the "2017 International Classification of the Ehlers-Danlos Syndromes" (hEDS) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.