Clinical trial NCT05718960: Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia
Official title: Randomised Trial of Traditional Dietary Advice Versus Reassurance-alone 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: 2023-02-08
Enrollment: 50
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 single-centre randomised trial evaluating traditional dietary advice (TDA) in PDS.

50 patients with PDS will be randomly assigned to a leaflet explaining reassurance-alone +/- TDA. The reassurance-alone group will be informed of the absence of organic disease and provided a diagnostic explanation of functional dyspepsia. The TDA group will receive the same information but also be recommended to eat smaller, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre.

Questionnaires are to be completed during the 4-week trial, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Napean Dyspepsia Quality of Life Index.

The primary endpoint(s) to define clinical response will be evaluated over weeks 3-4 as, i) ≥50% adequate relief of dyspeptic symptoms, and ii) \>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 functional dyspepsia
* Normal upper gastrointestinal endoscopy within last 3 years
* 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 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
* Current dietary interventions

Primary outcomes:
measure: Proportion of clinical responders between traditional dietary advice vs. reassurance alone based on the leuven postprandial distress scale (LPDS)
timeFrame: 4 weeks
measure: Proportion of clinical responders between traditional dietary advice vs. reassurance alone
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in Gastrointestinal Symptom Rating Irritable Bowel syndrome Scale
timeFrame: 4 weeks
measure: Changes in Napean Dyspepsia-related Quality of Life Index
timeFrame: 4 weeks
measure: Changes in Hospital Anxiety and Depression scale
timeFrame: 4 weeks
measure: Changes in Somatic Symptom reporting
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
Study officials:
References: