Comparing traditional dietary advice to a low FODMAP diet for postprandial dyspepsia
Randomised Trial of Traditional Dietary Advice Versus a Low FODMAP Diet in Postprandial Functional Dyspepsia
NA · Sheffield Teaching Hospitals NHS Foundation Trust · NCT05810168
This study tests whether following a low FODMAP diet helps people with meal-related stomach issues feel better compared to traditional dietary advice.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust (other) |
| Locations | 1 site (Sheffield, South Yorkshire) |
| Trial ID | NCT05810168 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of traditional dietary advice versus a low FODMAP diet in patients suffering from postprandial functional dyspepsia, a condition characterized by meal-related symptoms. Seventy patients will be randomly assigned to either receive traditional dietary recommendations or follow a low FODMAP diet, which restricts certain fermentable carbohydrates. The study aims to assess symptom relief and overall health improvement through dietary modifications. Participants will complete questionnaires to evaluate their symptoms and dietary adherence throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are individuals who meet the Rome IV criteria for postprandial functional dyspepsia and have had a normal upper gastrointestinal endoscopy within the last three years.
Not a fit: Patients with organic gastrointestinal diseases, severe systemic diseases, or those currently undergoing other dietary interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective dietary strategies to alleviate symptoms of postprandial dyspepsia for many patients.
How similar studies have performed: While dietary modifications for dyspepsia have been explored, this specific comparison of traditional advice versus a low FODMAP diet is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fulfil Rome IV symptoms criteria for postprandial functional dyspepsia * Normal upper gastrointestinal endoscopy within last 3years * 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 dietary interventions * 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
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.
Conditions: Dyspepsia, Functional Gastrointestinal Disorders