Traditional Dietary Advice Versus Low FODMAP Diet in Postprandial Functional Dyspepsia

NCT05810168 | Completed

• 1 other identifier: STH20655c
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dyspepsia; Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• Proportion of clinical responders between traditional dietary advice vs. a Low FODMAP diet on the leuven postprandial distress scale (LPDS)

  The Leuven Postprandial Distress Scale (LPDS) assesses the severity of 8 upper gastrointestinal symptoms scored from 0 (none) to 4 (very severe). A difference of 0.5 from baseline for the cardinal PDS symptoms (average of first 3 questions) will be used as a cut-off to determine clinical response by comparing average pre-treatment scores with the average score during weeks 4-6.

  6 weeks

Secondary Outcomes (6)

• Proportion of clinical responders between traditional dietary advice vs. a low FODMAP diet

  6 weeks

• Changes in Gastrointestinal Symptom Rating Irritable Bowel syndrome Scale

  6 weeks

• Changes in Napean Dyspepsia-related Quality of Life Index

  6 weeks

• Changes in Hospital Anxiety and Depression scale

  6 weeks

• Changes in Somatic Symptom reporting

  6 weeks

Study Arms (2)

Traditional Dietary Advice

ACTIVE COMPARATOR

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

Other: Dietary modifications

Low FODMAP diet

ACTIVE COMPARATOR

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.

Other: Dietary modifications

Interventions

Dietary modifications OTHER

TDA and low FODMAP diet

Low FODMAP diet; Traditional Dietary Advice

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Dyspepsia; Gastrointestinal Diseases

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: August 30, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)