Comparing dietary advice to reassurance for post-meal discomfort
Randomised Trial of Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia
This study is testing whether giving dietary advice along with reassurance can help people with post-meal discomfort feel better compared to just reassurance alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Sheffield, South Yorkshire) |
| Trial ID | NCT05718960 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of traditional dietary advice compared to reassurance alone in patients suffering from postprandial distress syndrome (PDS), a common form of functional dyspepsia. Fifty participants will be randomly assigned to receive either reassurance about their condition or reassurance plus dietary recommendations aimed at alleviating symptoms. The dietary advice includes suggestions to eat smaller, more frequent meals and to limit certain food and drink types. Participants will complete questionnaires over a four-week period to assess symptom relief and overall satisfaction.
Who should consider this trial
Good fit: Ideal candidates are adults who meet the Rome IV criteria for functional dyspepsia and have had a normal upper gastrointestinal endoscopy within the last three years.
Not a fit: Patients with organic gastrointestinal diseases or severe systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective dietary strategies to alleviate symptoms of functional dyspepsia, improving patients' quality of life.
How similar studies have performed: While studies on dietary modifications for functional dyspepsia are limited, similar approaches have shown promise in managing gastrointestinal disorders.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sheffield, South Yorkshire
- Royal Hallamshire Hospital — Sheffield, South Yorkshire, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.