Traditional Dietary Advice Versus Low FODMAP Diet in Postprandial Functional Dyspepsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2026-05-31

Brief Summary

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Functional dyspepsia is common, affecting 7.2% of the global population, and associated with substantial health impairment. Almost 80% of patients with functional dyspepsia report meal-related symptoms and are classified as having the postprandial distress syndrome (PDS) variant. However, studies evaluating dietary modifications in PDS are sparse.

The investigators will perform a randomised trial evaluating traditional dietary advice (TDA) vs. a diet low in fermentable fermentable oligo-, di-, mono- saccharides and polyols (low FODMAP diet) in PDS.

70 patients with PDS will be randomly assigned TDA or a low FODMAP diet. The TDA group will be recommended to eat small, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre. The low FODMAP diet group will be advised to exclude fermentable carbohydrates, which are present in wheat-based products, many fruits/vegetables, pulses, beans, dairy, and sweeteners.

Questionnaires are to be completed during the 6-week trial, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Nepean Dyspepsia Quality of Life Index.

The primary endpoint to define clinical response will be evaluated over weeks 4-6 as \>0.5-point reduction in the PDS subscale of the LPDS (calculated as the mean scores for early satiety, postprandial fullness, and upper abdominal bloating).

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Detailed Description

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Conditions

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Dyspepsia Functional Gastrointestinal Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional Dietary Advice

Recommended to eat smaller, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre

Group Type ACTIVE_COMPARATOR

Dietary modifications

Intervention Type OTHER

TDA and low FODMAP diet

Low FODMAP diet

FODMAPs are fermentable carbohydrates that increase intestinal water and gas production that, in those with visceral hypersensitivity, induces gastrointestinal symptoms. The low FODMAP diet therefore excludes fermentable carbohydrates, which are present in wheat-based products, many fruits/vegetables, pulses, beans, dairy, and sweeteners.

Group Type ACTIVE_COMPARATOR

Dietary modifications

Intervention Type OTHER

TDA and low FODMAP diet

Interventions

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Dietary modifications

TDA and low FODMAP diet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Fulfil Rome IV symptoms criteria for postprandial functional dyspepsia
* Normal upper gastrointestinal endoscopy within last 3years
* Online access
* English literate

Exclusion Criteria

* Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac disease)
* Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy)
* Documented H.pylori in the last 3 months
* History of eating disorders
* Body mass index \<20
* Current dietary interventions
* Current use of opioids or anti-inflammatory drugs
* Severe systemic disease (e.g. cardiac, renal, respiratory) necessitating frequent medical consultations)
* Pregnant
* Diabetes mellitus
* Scleroderma
* Memory impairment

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No