Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia

NHS Foundation Trust

Status: Enrolling

Conditions: Functional Gastrointestinal Disorders; Dyspepsia

Treatments: Behavioral: Traditional dietary advice; Other: Reassurance-alone

Study type: Interventional

Funder types: Other

Identifiers

NCT05718960

STH20655a

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Reassurance-alone

Placebo Comparator group

Treatment:

Other: Reassurance-alone

Traditional Dietary Advice

Active Comparator group

Treatment:

Behavioral: Traditional dietary advice