Low FODMAP Diet in FD (PDS)

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Apr 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a low-FODMAP diet can help people with functional dyspepsia, a condition that causes discomfort in the upper stomach after eating. The researchers want to find out if this diet can reduce symptoms like bloating and pain, and how it works to improve these issues. If you choose to participate, you will follow a specific low-FODMAP diet for six weeks, which means you’ll avoid certain types of carbohydrates that can cause digestive problems. After this period, you will gradually reintroduce some of those foods to see how they affect your symptoms.

To be eligible for the trial, you need to be between 18 and 70 years old and diagnosed with functional dyspepsia based on specific criteria. You must also have had a recent negative endoscopy (a test to look at your stomach) and be able to give written consent. Unfortunately, people with certain other gastrointestinal conditions or major psychiatric disorders, as well as those who have changed their diet recently or are pregnant, cannot participate. If you join the study, you’ll be contributing to important research that could help improve diet and treatment options for others dealing with similar digestive issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with Functional dyspepsia/ postprandial distress syndrome as per Rome IV diagnostic criteria
• • Symptom characteristics of dyspepsia (upper gastrointestinal symptoms occurring in the last 6 months and meal related (PDS))
• • Negative endoscopy (maximum 12 months old)
• • 2. Patients must provide witnessed written informed consent prior to any study procedures being performed
• • 3. Patients aged between 18 and 70 years inclusive
• • 4. Male or female patients
• 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.