Functional DyspepsiaFFDNCT06388330
The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms
A study testing low FODMAP diet in people with Functional Dyspepsia and FODMAP Diet, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
In this study, the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Dyspepsia, FODMAP Diet
- What is being tested?
- low FODMAP diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Apr 2019to 8 Mar 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with functional dyspepsia (postprandial distress syndrome)
- written informed consent
- 18-70 years
Who cannot join
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
- Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) and of gastro-oesophageal reflux disease (GERD)
- Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.
- Females who are pregnant or lactating are excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms (Postprandial Distress Syndrome According to the Rome IV Consensus)
In this study, the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD.
Read the detailed description
The study design starts with a baseline period of 2 weeks, includes 6 weeks of a 'strict' FODMAP diet (no blinded), followed by a 9 week 'reintroduction' phase (single blind). Based on the patients' symptom results following each of these challenges, patients will then follow the 'moderate' FODMAP diet, where the FODMAPs that did not trigger any symptoms during the challenge tests can now be consumed. Finally patients follow 2 weeks of a diet 'moderate' in FODMAP levels (no blinded). Blood and stool samples will be collected during the complete trial at several timepoints. In addition, before and after the strict diet phase a gastroscopy will be performed as well as an intragastric pressure measurement and breath test.
- Conditions
- Functional Dyspepsia, FODMAP Diet
- Being tested
- low FODMAP diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low FODMAP dietOther
strict low FODMAP diet followed by reintroduction of different FODMAPs and glucose (control)
| Study group | Role | What they receive |
|---|---|---|
| low FODMAP diet | Experimental | Not described Receives: Other: low FODMAP diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on gastrointestinal symptoms
The primary endpoint is to evaluate the efficacy of low FODMAP diet on gastrointestinal symptoms in FD. Based on the LPDS questionnaire (Leuven Postprandial Distress Syndrome Score), the primary endpoint is defined. This questionnaire contains questions with a scoring system from 0 till maximum 5 with higher scores indicating higher symptom severity. An improvement of 0.5 is considered clinically meaningful.
Measured: 2 years
Secondary outcomes (7)
Reintroduction period
Percentage of patients experiencing symptom worsening upon blinded reintroduction of single FODMAPs by means of LPDS daily diaries
Measured: 2 years
Evaluation of the low FODMAP diet on IBS related symptoms
by IBS-SSS and IBS-QoL questionnares
Measured: 2 years
Evaluation of the low FODMAP diet on symptom response and quality of life
by PAGISYM and SFNDI questionnaires
Measured: 2 years
Evaluation of the low FODMAP diet on depression, somatization
by PHQ
Measured: 2 years
Evaluation of the low FODMAP diet on duodenal barrier function
Duodenal mucosal integrity was evaluated in adapted mini-Ussing chambers and defined by transepithelial electrical resistance (TEER) and paracellular permeability for FITC dextran (macromolecular flux) (4kDa).
Measured: 2 years
Evaluation of the low FODMAP diet on gastric emptying
The C13-octanoic breath test was used to measure gastric emptying rate.
Measured: 2 years
Evaluation of the low FODMAP diet on gastric accommodation
Intra-gastric pressure measurement was used to quantify gastric accommodation at baseline and at the end of the low FODMAP diet.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start26 Apr 2019
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388330
- Sponsor's protocol ID
- s61692
- Acronym
- FFD
- Status last verified
- Apr 2024
- First submitted
- 6 May 2020
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms (Postprandial Distress Syndrome According to the Rome IV Consensus)
- ClinicalTrials.gov ID
- NCT06388330
- Acronym / sponsor ID
- FFD / s61692
- Conditions
- Functional Dyspepsia, FODMAP Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 29 Apr 2024 (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.
In this study, the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD.
Detailed description
The study design starts with a baseline period of 2 weeks, includes 6 weeks of a 'strict' FODMAP diet (no blinded), followed by a 9 week 'reintroduction' phase (single blind). Based on the patients' symptom results following each of these challenges, patients will then follow the 'moderate' FODMAP diet, where the FODMAPs that did not trigger any symptoms during the challenge tests can now be consumed. Finally patients follow 2 weeks of a diet 'moderate' in FODMAP levels (no blinded). Blood and stool samples will be collected during the complete trial at several timepoints. In addition, before and after the strict diet phase a gastroscopy will be performed as well as an intragastric pressure measurement and breath test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| low FODMAP diet | Experimental | Other: low FODMAP diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with functional dyspepsia (postprandial distress syndrome)
- written informed consent
- 18-70 years
Key exclusion criteria (5 listed)
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
- Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) and of gastro-oesophageal reflux disease (GERD)
- Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.
- Females who are pregnant or lactating are excluded from the study.
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 |
|---|---|---|
| low FODMAP dietstrict low FODMAP diet followed by reintroduction of different FODMAPs and glucose (control) | Other | low FODMAP diet |
Primary outcome
Improvement on gastrointestinal symptoms
Time frame: 2 years
The primary endpoint is to evaluate the efficacy of low FODMAP diet on gastrointestinal symptoms in FD. Based on the LPDS questionnaire (Leuven Postprandial Distress Syndrome Score), the primary endpoint is defined. This questionnaire contains questions with a scoring system from 0 till maximum 5 with higher scores indicating higher symptom severity. An improvement of 0.5 is considered clinically meaningful.
7 secondary outcomes
Reintroduction period
Time frame: 2 years
Evaluation of the low FODMAP diet on IBS related symptoms
Time frame: 2 years
Evaluation of the low FODMAP diet on symptom response and quality of life
Time frame: 2 years
Evaluation of the low FODMAP diet on depression, somatization
Time frame: 2 years
Evaluation of the low FODMAP diet on duodenal barrier function
Time frame: 2 years
Evaluation of the low FODMAP diet on gastric emptying
Time frame: 2 years
Evaluation of the low FODMAP diet on gastric accommodation
Time frame: 2 years
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 29 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low FODMAP diet in people with Functional Dyspepsia and FODMAP Diet, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 inclusion and 5 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 29 Apr 2024. 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 Belgium. 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?
Improvement on gastrointestinal symptoms (time frame: 2 years). 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 29 Apr 2024.