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NCT05810168
Traditional Dietary Advice Versus Low FODMAP Diet in Postprandial Functional Dyspepsia
NA trial testing Dietary modifications in Dyspepsia in 70 participants. Currently enrolling.
31 May 2026
Quick facts
| Lead sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 30 August 2023 |
| Primary completion | 31 May 2026 |
| Estimated completion | 31 May 2026 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Dietary modifications
Conditions studied
- Dyspepsia — all drugs for Dyspepsia →
- Functional Gastrointestinal Disorders — all drugs for Functional Gastrointestinal Disorders →
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Who can join
Adults 18 to 60, any sex, with Dyspepsia or Functional Gastrointestinal Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 randomised trial evaluating traditional dietary advice (TDA) vs. a diet low in fermentable fermentable oligo-, di-, mono- saccharides and polyols (low FODMAP diet) in PDS. 70 patients with PDS will be randomly assigned TDA or a low FODMAP diet. The TDA group will be recommended to eat small, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre. The low FODMAP diet group will be advised to exclude fermentable carbohydrates, which are present in wheat-based products, many fruits/vegetables, pulses, beans, dairy, and sweeteners. Questionnaires are to be completed during the 6-week trial, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Nepean Dyspepsia Quality of Life Index. The primary endpoint to define clinical response will be evaluated over weeks 4-6 as \>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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05810168
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05810168 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sheffield Teaching Hospitals NHS Foundation Trust
- Last refreshed: 22 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05810168.
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