Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia

NCT05718960 | Recruiting

• 1 other identifier: STH20655a
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Dyspepsia; Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Changes in Gastrointestinal Symptom Rating Irritable Bowel syndrome Scale

  4 weeks

• Changes in Napean Dyspepsia-related Quality of Life Index

  4 weeks

• Changes in Hospital Anxiety and Depression scale

  4 weeks

• Changes in Somatic Symptom reporting

  4 weeks

Study Arms (2)

Reassurance-alone

PLACEBO COMPARATOR

Other: Reassurance-alone

Traditional Dietary Advice

ACTIVE COMPARATOR

Behavioral: Traditional dietary advice

Interventions

Reassurance-alone OTHER

To be informed of the absence of organic disease and provided a diagnostic explanation of functional dyspepsia

Reassurance-alone

Traditional dietary advice BEHAVIORAL

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

Traditional Dietary Advice

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dyspepsia; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: September 1, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 31, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)