Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia

Last updated: April 18, 2024
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Gastrointestinal Diseases And Disorders

Bowel Dysfunction

Treatment

Traditional dietary advice

Reassurance-alone

Clinical Study ID

NCT05718960
STH20655a
  • Ages 18-60
  • All Genders

Study 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

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliacdisease)
  • 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 frequentmedical consultations
  • Pregnant
  • Diabetes mellitus
  • Scleroderma
  • Memory impairment
  • Current dietary interventions

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Traditional dietary advice
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Royal Hallamshire Hospital

    Sheffield, South Yorkshire S10 2JF
    United Kingdom

    Active - Recruiting

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