Clinical trial NCT06388330: The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Dyspepsia
FODMAP Diet
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* patients with functional dyspepsia (postprandial distress syndrome)
* written informed consent
* 18-70 years

Exclusion Criteria:

1. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
2. 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
3. Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) and of gastro-oesophageal reflux disease (GERD)
4. Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.
5. Females who are pregnant or lactating are excluded from the study.

Primary outcomes:
measure: Improvement on gastrointestinal symptoms
timeFrame: 2 years
Secondary outcomes:
measure: Reintroduction period
timeFrame: 2 years
measure: Evaluation of the low FODMAP diet on IBS related symptoms
timeFrame: 2 years
measure: Evaluation of the low FODMAP diet on symptom response and quality of life
timeFrame: 2 years
measure: Evaluation of the low FODMAP diet on depression, somatization
timeFrame: 2 years
measure: Evaluation of the low FODMAP diet on duodenal barrier function
timeFrame: 2 years
measure: Evaluation of the low FODMAP diet on gastric emptying
timeFrame: 2 years
measure: Evaluation of the low FODMAP diet on gastric accommodation
timeFrame: 2 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
Study officials:
References: