Randomised Trial of Traditional Dietary Advice Versus a Low FODMAP Diet in Postprandial Functional Dyspepsia

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Fulfil Rome IV symptoms criteria for postprandial functional dyspepsia

• Normal upper gastrointestinal endoscopy within last 3years

• Online access

• English literate

Locations
Other Locations
United Kingdom
Royal Hallamshire Hospital
RECRUITING
Sheffield
Time Frame
Start Date: 2023-08-30
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 70
Treatments
Active_comparator: Traditional Dietary Advice
Recommended to eat smaller, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Sheffield Teaching Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov