Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718960
• Other study ID #: STH20655a
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 31, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Dyspepsia
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Other:
• Reassurance-alone
To be informed of the absence of organic disease and provided a diagnostic explanation of functional dyspepsia

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

Locations

Country	Name	City	State
United Kingdom	Royal Hallamshire Hospital	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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