Functional DyspepsiaCLEFDNCT05666154
Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia
A study testing Real diet, Wheat exclusion diet and Soy exclusion diet in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
After a thorough baseline evaluation, functional dyspepsia (FD) patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (CLE). Patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Real diet, Wheat exclusion diet and Soy exclusion diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Dec 2021to 31 Aug 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 y/o (70 years included)
- Male or female subjects
- FD (PDS, EPS or overlap) according to Rome IV criteria
- Provide written informed consent to participate in the study
- Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
- Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.
Who cannot join
- Pregnant or breastfeeding women
- History of major surgery of the gastrointestinal tract (cholecystectomy and uncomplicated appendectomy are allowed)
- Symptoms predominantly associated with irritable bowel syndrome or gastro-esophageal reflux disease
- IgE-mediated food allergies identified by immunocaps blood tests
- Known underlying organic gastrointestinal disease
- Current use of NSAIDs, proton-pump inhibitors, systemic histamine-receptor antagonists, mast cell stabilizers, corticosteroids, opioids (need to be stopped at least 2 weeks). Use of antibiotics in the past 6 weeks.
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- Allergy to Fluorescein or Propofol
- Known celiac disease
- Following a diet, interfering with the study diet in opinion to the investigators
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Jolien Schol, MD, +3216345663, jolien.schol@kuleuven.be
About this study
Official title: Targeted Elimination Diet in FD Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy
After a thorough baseline evaluation, functional dyspepsia (FD) patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (CLE). Patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet) from their diet for 4 weeks in a randomized, blinded crossover fashion.
The aim of the trial is to assess the symptomatic response to the targeted diet and further elucidate mechanisms underlying the acute mucosal reactions observed in CLE upon nutrient exposure.
- Conditions
- Functional Dyspepsia
- Being tested
- Real diet, Sham diet, Wheat exclusion diet, Soy exclusion diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real dietOther
Diet excluding either trigger nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger)
Sham dietOther
Diet excluding either sham nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger) or wheat and soy in a blinded crossover fashion (CLE negative individuals without identified trigger)
Wheat exclusion dietOther
Diet excluding wheat in a blinded crossover fashion (CLE negative individuals without identified trigger)
Soy exclusion dietOther
Diet excluding soy in a blinded crossover fashion (CLE negative individuals without identified trigger)
| Study group | Role | What they receive |
|---|---|---|
| Real diet | Active comparator | Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE Receives: Other: Real diet |
| Sham diet | Sham comparator | Diet excluding a sham nutrient without acute mucosal reaction in CLE Receives: Other: Sham diet |
| Wheat exclusion diet | Active comparator | In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy. Receives: Other: Wheat exclusion diet |
| Soy exclusion diet | Active comparator | In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy. Receives: Other: Soy exclusion diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rates in targeted diet vs sham diet
Response defined by an improvement of minimum 0.5 points on the LPDS scale
Measured: After 4 weeks of dietary intervention
Secondary outcomes (5)
Baseline duodenal transepithelial electrical resistance between groups
Differences in baseline permeability measures (TEER and flux, measured with ussing chambers on duodenal biopsies) between CLE positive and negative patients and healthy volunteers using Ussing chambers
Measured: At baseline
Baseline duodenal flux of horse-radish peroxidase between groups
Differences in baseline permeability measures (flux, measured with ussing chambers on duodenal biopsies) between CLE positive and negative patients and healthy volunteers using Ussing chambers
Measured: At baseline
Evolution of duodenal flux of horse-radish peroxidase between dietary interventions
Differences in permeability measures (HRP flux, measured with ussing chambers on duodenal biopsies) between dietary interventions (i.e. verum, sham, wheat and soy) during the dietary interventions using urinary Lactulose/Mannitol/Sucralose ratio
Measured: Baseline and after 4 weeks of diet
Evolution of duodenal transepithelial electrical resistance between dietary interventions
Differences in permeability measures (TEER, measured with ussing chambers on duodenal biopsies) between dietary interventions (i.e. verum, sham, wheat and soy) during the dietary interventions using urinary Lactulose/Mannitol/Sucralose ratio
Measured: Baseline and after 4 weeks of diet
Baseline mucosal immune cell composition between groups
Differences in baseline mucosal mast-cell and eosinophil counts between CLE positive and negative patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start5 Dec 2021
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666154
- Sponsor's protocol ID
- S65735
- Acronym
- CLEFD
- Status last verified
- Jul 2024
- First submitted
- 9 Dec 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Elimination Diet in FD Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy
- ClinicalTrials.gov ID
- NCT05666154
- Acronym / sponsor ID
- CLEFD / S65735
- Conditions
- Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 5 Dec 2021 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 27 Dec 2022 (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.
After a thorough baseline evaluation, functional dyspepsia (FD) patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (CLE). Patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet) from their diet for 4 weeks in a randomized, blinded crossover fashion.
The aim of the trial is to assess the symptomatic response to the targeted diet and further elucidate mechanisms underlying the acute mucosal reactions observed in CLE upon nutrient exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Real diet | Active comparator | Other: Real dietDiet excluding the trigger nutrient identified by an acute mucosal reaction in CLE |
| Sham diet | Sham comparator | Other: Sham dietDiet excluding a sham nutrient without acute mucosal reaction in CLE |
| Wheat exclusion diet | Active comparator | Other: Wheat exclusion dietIn patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy. |
| Soy exclusion diet | Active comparator | Other: Soy exclusion dietIn patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-70 y/o (70 years included)
- Male or female subjects
- FD (PDS, EPS or overlap) according to Rome IV criteria
- Provide written informed consent to participate in the study
- Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding women
- History of major surgery of the gastrointestinal tract (cholecystectomy and uncomplicated appendectomy are allowed)
- Symptoms predominantly associated with irritable bowel syndrome or gastro-esophageal reflux disease
- IgE-mediated food allergies identified by immunocaps blood tests
- Known underlying organic gastrointestinal 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 |
|---|---|---|
| Real dietDiet excluding either trigger nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger) | Other | Real diet |
| Sham dietDiet excluding either sham nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger) or wheat and soy in a blinded crossover fashion (CLE negative individuals without identified trigger) | Other | Sham diet |
| Wheat exclusion dietDiet excluding wheat in a blinded crossover fashion (CLE negative individuals without identified trigger) | Other | Wheat exclusion diet |
| Soy exclusion dietDiet excluding soy in a blinded crossover fashion (CLE negative individuals without identified trigger) | Other | Soy exclusion diet |
Primary outcome
Responder rates in targeted diet vs sham diet
Time frame: After 4 weeks of dietary intervention
Response defined by an improvement of minimum 0.5 points on the LPDS scale
5 secondary outcomes
Baseline duodenal transepithelial electrical resistance between groups
Time frame: At baseline
Baseline duodenal flux of horse-radish peroxidase between groups
Time frame: At baseline
Evolution of duodenal flux of horse-radish peroxidase between dietary interventions
Time frame: Baseline and after 4 weeks of diet
Evolution of duodenal transepithelial electrical resistance between dietary interventions
Time frame: Baseline and after 4 weeks of diet
Baseline mucosal immune cell composition between groups
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real diet, Wheat exclusion diet and Soy exclusion diet in people with Functional Dyspepsia, 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 6 inclusion and 9 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 3 Jul 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. Some participants in this study may receive a placebo. 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 Jolien Schol, MD (+3216345663, jolien.schol@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder rates in targeted diet vs sham diet (time frame: After 4 weeks of dietary intervention). 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 3 Jul 2024.