The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms

NCT06388330 | Completed

• 1 other identifier: s61692
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia; FODMAP Diet

Outcome Measures

Primary Outcomes (1)

• Improvement on gastrointestinal symptoms

  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.

  2 years

Secondary Outcomes (7)

• Reintroduction period

  2 years

• Evaluation of the low FODMAP diet on IBS related symptoms

  2 years

• Evaluation of the low FODMAP diet on symptom response and quality of life

  2 years

• Evaluation of the low FODMAP diet on depression, somatization

  2 years

• Evaluation of the low FODMAP diet on duodenal barrier function

  2 years

Study Arms (1)

low FODMAP diet

EXPERIMENTAL

Other: low FODMAP diet

Interventions

low FODMAP diet OTHER

strict low FODMAP diet followed by reintroduction of different FODMAPs and glucose (control)

low FODMAP diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with functional dyspepsia (postprandial distress syndrome)
• written informed consent
• years

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Interventions

FODMAP Diet

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: open label strict diet phase blinded participant during reintroduction
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: April 29, 2024
• Study Start: April 26, 2019
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

BE (1)