FODMAP Diet, Functional Dyspepsia
Conditions
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.
Interventions
OTHERlow FODMAP diet
strict low FODMAP diet followed by reintroduction of different FODMAPs and glucose (control)
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
open label strict diet phase blinded participant during reintroduction
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement on gastrointestinal symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the low FODMAP diet on IBS related symptoms | 2 years | by IBS-SSS and IBS-QoL questionnares |
| Evaluation of the low FODMAP diet on symptom response and quality of life | 2 years | by PAGISYM and SFNDI questionnaires |
| Evaluation of the low FODMAP diet on depression, somatization | 2 years | by PHQ |
| Reintroduction period | 2 years | Percentage of patients experiencing symptom worsening upon blinded reintroduction of single FODMAPs by means of LPDS daily diaries |
| Evaluation of the low FODMAP diet on gastric emptying | 2 years | The C13-octanoic breath test was used to measure gastric emptying rate. |
| Evaluation of the low FODMAP diet on gastric accommodation | 2 years | Intra-gastric pressure measurement was used to quantify gastric accommodation at baseline and at the end of the low FODMAP diet. |
| Evaluation of the low FODMAP diet on duodenal barrier function | 2 years | 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). |
Countries
Belgium
Outcome results
None listed