Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia

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

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).

Study Overview

• Status: Recruiting
• Conditions: Dyspepsia; Functional Gastrointestinal Disorders
• Intervention / Treatment: Other: Reassurance-alone; Behavioral: Traditional dietary advice

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Recruiting
      • Royal Hallamshire Hospital
      • Contact: Jemima Clarke; Phone Number: 01142265943; Email: sth.researchadministration@nhs.net
      • Principal Investigator: Imran Aziz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Reassurance-alone	Other: Reassurance-alone; To be informed of the absence of organic disease and provided a diagnostic explanation of functional dyspepsia
Active Comparator: Traditional Dietary Advice	Behavioral: Traditional dietary advice; To receive the same information as reassurance-alone group but also recommended to eat smaller, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of clinical responders between traditional dietary advice vs. reassurance alone based on the leuven postprandial distress scale (LPDS)	The Leuven Postprandial Distress Scale (LPDS) assesses the severity of 8 upper gastrointestinal symptoms scored from 0 (none) to 4 (very severe). A difference of 0.7 from baseline for the cardinal PDS symptoms (average of first 3 questions) will be used as a cut-off to determine clinical response by comparing averaged pre-treatment scores with the average score during the weeks 3-4.	4 weeks
Proportion of clinical responders between traditional dietary advice vs. reassurance alone	Self-reported adequate relief of dyspeptic symptoms as a binary answer (yes or no). A responder will be defined if ≥50% adequate relief of dyspeptic symptoms during weeks 3-4	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Gastrointestinal Symptom Rating Irritable Bowel syndrome Scale	The validated Gastrointestinal Symptom Rating Scale assesses the symptoms of irritable bowel syndrome, depicting problems with satiety, abdominal pain, diarrhoea, constipation and bloating. Higher scores represent greater symptom severity. Change in monthly scores will be compared within- and between-treatments for both cohorts combined.	4 weeks
Changes in Napean Dyspepsia-related Quality of Life Index	The Napean Dyspepsia Scale is a validated questionnaire assessing dyspepsia-related quality of life syndrome, with higher scores representing worse quality of life. Change in monthly scores will be compared within- and between-treatments for both cohorts combined.	4 weeks
Changes in Hospital Anxiety and Depression scale	The Hospital Anxiety and Depression Scale is a validated questionnaire assessing mood, with higher scores representing worse mood. Change in monthly scores will be compared within- and between-treatments for both cohorts combined.	4 weeks
Changes in Somatic Symptom reporting	The validated patient health questionnaire-12 assess extra-intestinal somatic symptoms, with higher scores representing greater somatic symptom severity. Change in monthly scores will be compared within- and between-treatments for both cohorts combined.	4 weeks

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: STH20655a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No