Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia

NCT ID: NCT05718960

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2026-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reassurance-alone

Group Type: PLACEBO_COMPARATOR

Reassurance-alone

Intervention Type: OTHER

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

Traditional Dietary Advice

Group Type: ACTIVE_COMPARATOR

Traditional dietary advice

Intervention Type: 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

Interventions

Reassurance-alone

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

Intervention Type: OTHER

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Jemima Clarke

Role: primary

sth.researchadministration@nhs.net

01142265943

Other Identifiers

STH20655a

Identifier Type: -

Identifier Source: org_study_id