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Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia

Primary Purpose

Dyspepsia, Functional Gastrointestinal Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Reassurance-alone
Traditional dietary advice
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Hallamshire HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Reassurance-alone

Traditional Dietary Advice

Arm Description

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 30, 2023
Last Updated
March 30, 2023
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05718960
Brief Title
Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia
Official Title
Randomised Trial of Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Functional Gastrointestinal Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reassurance-alone
Arm Type
Placebo Comparator
Arm Title
Traditional Dietary Advice
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Reassurance-alone
Intervention Description
To be informed of the absence of organic disease and provided a diagnostic explanation of functional dyspepsia
Intervention Type
Behavioral
Intervention Name(s)
Traditional dietary advice
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of clinical responders between traditional dietary advice vs. reassurance alone based on the leuven postprandial distress scale (LPDS)
Description
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.
Time Frame
4 weeks
Title
Proportion of clinical responders between traditional dietary advice vs. reassurance alone
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes in Gastrointestinal Symptom Rating Irritable Bowel syndrome Scale
Description
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.
Time Frame
4 weeks
Title
Changes in Napean Dyspepsia-related Quality of Life Index
Description
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.
Time Frame
4 weeks
Title
Changes in Hospital Anxiety and Depression scale
Description
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.
Time Frame
4 weeks
Title
Changes in Somatic Symptom reporting
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jemima Clarke
Phone
01142265943
Email
sth.researchadministration@nhs.net
First Name & Middle Initial & Last Name & Degree
Imran Aziz, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia

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