Clinical trial NCT05810168: Traditional Dietary Advice Versus Low FODMAP Diet in Postprandial Functional Dyspepsia
Official title: Randomised Trial of Traditional Dietary Advice Versus a Low FODMAP Diet in Postprandial Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyspepsia
Functional Gastrointestinal Disorders
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of clinical responders between traditional dietary advice vs. a Low FODMAP diet on the leuven postprandial distress scale (LPDS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Proportion of clinical responders between traditional dietary advice vs. a low FODMAP diet
timeFrame: 6 weeks
measure: Changes in Gastrointestinal Symptom Rating Irritable Bowel syndrome Scale
timeFrame: 6 weeks
measure: Changes in Napean Dyspepsia-related Quality of Life Index
timeFrame: 6 weeks
measure: Changes in Hospital Anxiety and Depression scale
timeFrame: 6 weeks
measure: Changes in Somatic Symptom reporting
timeFrame: 6 weeks
measure: Changes in nutritional intake
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
Study officials:
References: