Randomised Trial of Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, 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 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Fulfil Rome IV symptoms criteria for functional dyspepsia

• Normal upper gastrointestinal endoscopy within last 3 years

• Online access

• English literate

Locations
Other Locations
United Kingdom
Royal Hallamshire Hospital
RECRUITING
Sheffield
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 50
Treatments
Placebo_comparator: Reassurance-alone
Active_comparator: Traditional Dietary Advice
Related Therapeutic Areas
Sponsors
Leads: Sheffield Teaching Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov