Functional DyspepsiaNCT05651386
The Six Food Elimination in Postprandial Distress Syndrome
A study testing Diet in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The six food elimination diet, as known in eosinophilic esophagitis, will be performed in 15 patients with functional dyspepsia (subtype postprandial distress syndrome). Screening will exclude patients with allergies by performing immunocaps on blood. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Feb 2020to 31 Jan 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Functional dyspepsia patients with meal related symptoms (Rome IV Postprandial Distress Syndrome, PDS)
- Witnessed written informed consent prior to any study procedures
- Patients aged between 18 and 70 years inclusive
- Male or female patients
- Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Women of non-childbearing potential may be included if surgically sterile or postmenopausal with at least 2 year without spontaneous menses.
- Subject is capable to understand the study and the questionnaires, and to comply with the study requirements.
Who cannot join
- History of gastrointestinal surgery (other than appendectomy).
- Organic gastro-intestinal disease
- Major psychiatric disorder
- Patients with eosinophilic esophagitis
- Presence of diabetes mellitus
- Presence of coeliac disease, lupus, scleroderma and other systemic auto-immune disease.
Show all 14Show fewer
- Active H. Pylori infection or < 6 months after eradication
- Predominant irritable bowel syndrome (IBS)
- Predominant gastro-oesophageal reflux disease (GERD)
- Atopic constitution or food allergy
- Ongoing diet which interferes with the 6 food elimination diet.
- Drugs altering gastric emptying or anti-inflammatory drugs
- Females who are pregnant or lactating
- Patients not capable to understand or be compliant with the study.
Trial locations and contacts
1 site in 1 country.
Florencia Carbone, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven
Leuven, 3000
Jan Tack, MD, PhD, jan.tack@kuleuven.be
About this study
The six food elimination diet, as known in eosinophilic esophagitis, will be performed in 15 patients with functional dyspepsia (subtype postprandial distress syndrome). Screening will exclude patients with allergies by performing immunocaps on blood. Before and after the 8 weeks of diet, an gastroduodenoscopy with biopsies will be performed to evaluate duodenal eosinophilia, mast cells and permeability. To evaluate gastric sensorimotor function, a gastric emptying breath test and a barostat test will be performed before and after the diet.
Symptoms will be monitored with a daily diary (LPDS diary) and food intake will be evaluated during 2 weeks.
If there is an improvement of symptoms during the diet, a reintroduction period will start. This period will last 6 weeks. Every 2 weeks, two food groups will be reintroduced. When there is a clear worsening in symptoms, a new endoscopy with biopsies will be performed.
Read the detailed description
To assess the effect of the six food elimination diet on duodenal eosinophilia, an interventional study will be conducted in 15 patients.
The study design includes 8 weeks of a strict 6 food elimination diet, followed by an 8 week reintroduction phase in patients with symptom improvement. The duration of 8 weeks is based on the effect of the 6 FED in eosinophilic esophagitis.
Each subject will undergo a screening before the start of the diet. During the screening visit, all study procedures will be explained, the informed consent form will be signed by the participant, and the inclusion and exclusion criteria will be checked by revising the participant's medical history and by using screening GI symptom questionnaires (Rome IV questionnaire).
The screening visit will include a physical examination, medical history and a blood sample for IgE testing to exclude typical food allergies.
When eligibility is confirmed during the screening visit, a fourteen-day period starts. In this period, the LPDS diary (Leuven Postprandial distress syndrome) and food diary will be filled out on a daily basis to assess symptoms at baseline. The food diary will be available via an application for mobile phones or online use. The Comprehensive Nutrition Assessment Questionnaire will be filled in to analyse baseline food intake.
At visit 1, following tests will be conducted in a 2-day period (outpatient clinic):
- A gastroduodenoscopy with biopsies, optionally/preferably under sedation.
- A gastric barostat study.
- A gastric emptying breath test. If desired, the gastric emptying test can be performed at home and sent or taken to the clinic.
- Questionnaires (as specified in chapter 10.3.) After these tests, the 6 food elimination diet (6FED) will be explained by a trained dietician.
The diet will be followed during 8 weeks under supervision of this dietician with experience in eosinophilic esophagitis.
During the 6FED the compliance of patients will be evaluated by the use of diet diaries from week 6 to 8. Symptoms will be evaluated throughout the 8-week dietary restriction period using the daily LPDS diary. Patients will report daily food intake via an application for mobile phone or online use during two weeks of the diet period.
A telephone call will be scheduled after two and six weeks, to assess compliance.
After 8 weeks of six food elimination diet, a new gastroduodenoscopy with biopsies will be performed, as well as a new gastric barostat and gastric emptying breath test, as described at visit 1.
At visit 2, patients with a symptom improvement, defined as an average LPDS with 0.5 point or more compared to baseline will be sent for a consultation with our dietician for the explanation of reintroduction of nuts and fish.
This will be done in a non-blinded way.
During the reintroduction period, patients will visit the hospital every 2 weeks for visit 3, 4 and 5. First, fish and nuts will be reintroduced, than eggs and soy and lastly gluten and milk. Patients with symptom worsening, defined as an average LPDS with 0.5 point or more compared to the end of the 6FED diet period, will be invited to undergo a with gastroscopy with biopsies and a new blood sample for PBMCs.
During the entire study, patients will fill in the daily diary (LPDS).
- Conditions
- Functional Dyspepsia
- Being tested
- Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
No blinded, no controlled intervention.
| Study group | Role | What they receive |
|---|---|---|
| Six food elimination diet | Other | The six food elimination diet will be performed in all subjects. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duodenal eosinophilia
Measured with duodenal biopsies with H\&E staining
Measured: 8 weeks
Secondary outcomes (7)
Duodenal mast cells
Measured with duodenal biopsies with immunohistochemistry
Measured: 8 weeks
Duodenal permeability
Measured with duodenal biopsies with ussing chambers
Measured: 8 weeks
PDS symptoms
Measured with daily symptom diary (LPDS)
Measured: 8 weeks
Functional dyspepsia symptoms
Measured with PAGI-SYM
Measured: 8 weeks
Symptom severity
Measured with OSS
Measured: 8 weeks
Overall symptom improvement
Measured with OTE
Measured: 8 weeks
Quality of life
Measured with SF-NDI
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start19 Feb 2020
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, MD, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651386
- Sponsor's protocol ID
- s63494
- Status last verified
- Jul 2024
- First submitted
- 12 Feb 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- The Six Food Elimination in Postprandial Distress Syndrome
- ClinicalTrials.gov ID
- NCT05651386
- Acronym / sponsor ID
- s63494
- Conditions
- Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 15 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.
The six food elimination diet, as known in eosinophilic esophagitis, will be performed in 15 patients with functional dyspepsia (subtype postprandial distress syndrome). Screening will exclude patients with allergies by performing immunocaps on blood. Before and after the 8 weeks of diet, an gastroduodenoscopy with biopsies will be performed to evaluate duodenal eosinophilia, mast cells and permeability. To evaluate gastric sensorimotor function, a gastric emptying breath test and a barostat test will be performed before and after the diet.
Symptoms will be monitored with a daily diary (LPDS diary) and food intake will be evaluated during 2 weeks.
If there is an improvement of symptoms during the diet, a reintroduction period will start. This period will last 6 weeks. Every 2 weeks, two food groups will be reintroduced. When there is a clear worsening in symptoms, a new endoscopy with biopsies will be performed.
Detailed description
To assess the effect of the six food elimination diet on duodenal eosinophilia, an interventional study will be conducted in 15 patients.
The study design includes 8 weeks of a strict 6 food elimination diet, followed by an 8 week reintroduction phase in patients with symptom improvement. The duration of 8 weeks is based on the effect of the 6 FED in eosinophilic esophagitis.
Each subject will undergo a screening before the start of the diet. During the screening visit, all study procedures will be explained, the informed consent form will be signed by the participant, and the inclusion and exclusion criteria will be checked by revising the participant's medical history and by using screening GI symptom questionnaires (Rome IV questionnaire).
The screening visit will include a physical examination, medical history and a blood sample for IgE testing to exclude typical food allergies.
When eligibility is confirmed during the screening visit, a fourteen-day period starts. In this period, the LPDS diary (Leuven Postprandial distress syndrome) and food diary will be filled out on a daily basis to assess symptoms at baseline. The food diary will be available via an application for mobile phones or online use. The Comprehensive Nutrition Assessment Questionnaire will be filled in to analyse baseline food intake.
At visit 1, following tests will be conducted in a 2-day period (outpatient clinic):
- A gastroduodenoscopy with biopsies, optionally/preferably under sedation.
- A gastric barostat study.
- A gastric emptying breath test. If desired, the gastric emptying test can be performed at home and sent or taken to the clinic.
- Questionnaires (as specified in chapter 10.3.) After these tests, the 6 food elimination diet (6FED) will be explained by a trained dietician.
The diet will be followed during 8 weeks under supervision of this dietician with experience in eosinophilic esophagitis.
During the 6FED the compliance of patients will be evaluated by the use of diet diaries from week 6 to 8. Symptoms will be evaluated throughout the 8-week dietary restriction period using the daily LPDS diary. Patients will report daily food intake via an application for mobile phone or online use during two weeks of the diet period.
A telephone call will be scheduled after two and six weeks, to assess compliance.
After 8 weeks of six food elimination diet, a new gastroduodenoscopy with biopsies will be performed, as well as a new gastric barostat and gastric emptying breath test, as described at visit 1.
At visit 2, patients with a symptom improvement, defined as an average LPDS with 0.5 point or more compared to baseline will be sent for a consultation with our dietician for the explanation of reintroduction of nuts and fish.
This will be done in a non-blinded way.
During the reintroduction period, patients will visit the hospital every 2 weeks for visit 3, 4 and 5. First, fish and nuts will be reintroduced, than eggs and soy and lastly gluten and milk. Patients with symptom worsening, defined as an average LPDS with 0.5 point or more compared to the end of the 6FED diet period, will be invited to undergo a with gastroscopy with biopsies and a new blood sample for PBMCs.
During the entire study, patients will fill in the daily diary (LPDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Six food elimination diet | Other | Other: DietThe six food elimination diet will be performed in all subjects. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Functional dyspepsia patients with meal related symptoms (Rome IV Postprandial Distress Syndrome, PDS)
- Witnessed written informed consent prior to any study procedures
- Patients aged between 18 and 70 years inclusive
- Male or female patients
- Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Women of non-childbearing potential may be included if surgically sterile or postmenopausal with at least 2 year without spontaneous menses.
Key exclusion criteria (14 listed)
- History of gastrointestinal surgery (other than appendectomy).
- Organic gastro-intestinal disease
- Major psychiatric disorder
- Patients with eosinophilic esophagitis
- Presence of diabetes mellitus
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 |
|---|---|---|
| DietNo blinded, no controlled intervention. | Other | Six food elimination diet |
Primary outcome
Duodenal eosinophilia
Time frame: 8 weeks
Measured with duodenal biopsies with H\&E staining
7 secondary outcomes
Duodenal mast cells
Time frame: 8 weeks
Duodenal permeability
Time frame: 8 weeks
PDS symptoms
Time frame: 8 weeks
Functional dyspepsia symptoms
Time frame: 8 weeks
Symptom severity
Time frame: 8 weeks
Overall symptom improvement
Time frame: 8 weeks
Quality of life
Time frame: 8 weeks
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: No
Related trials for Functional Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
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.
Florencia Carbone, PhD contact
Jan Tack, MD, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 14 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. 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 (16 34 56 63 ext. 0032, jolien.schol@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duodenal eosinophilia (time frame: 8 weeks). 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; AzTrials last refreshed its copy on 8 Nov 2026.