Clinical Trials Logo
  1. Home
  2. Dyspepsia
  3. NCT05718960

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 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05718960
Study type Interventional
Source Sheffield Teaching Hospitals NHS Foundation Trust
Contact
Status Recruiting
Phase N/A
Start date September 1, 2022
Completion date May 31, 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06094062 - Smartphone App-assisted PPI N/A
Completed NCT03941288 - Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia Phase 2
Completed NCT04429802 - The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity N/A
Not yet recruiting NCT06369753 - Visible Abdominal Distension N/A
Withdrawn NCT02863822 - Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia. N/A
Recruiting NCT00978159 - Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia Phase 4
Completed NCT00723502 - Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients Phase 2
Completed NCT00217347 - Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy N/A
Completed NCT00148603 - Montelukast in the Treatment of Duodenal Eosinophilia N/A
Terminated NCT00220844 - Tricyclic Antidepressants (TCAs) on Gastric Emptying N/A
Completed NCT00232037 - Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia Phase 3
Completed NCT00110968 - Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia Phase 3
Completed NCT00232102 - Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia Phase 3
Completed NCT00164996 - Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia Phase 3
Terminated NCT04247100 - A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders N/A
Completed NCT05750641 - The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional Study
Completed NCT03252743 - ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study. N/A
Completed NCT04697641 - Helicobacter Pylori Eradication in Functional Dyspepsia N/A
Recruiting NCT04918329 - Functional Digestive Disorders Observatory
Recruiting NCT01696734 - Domperidone in Treating Patients With Gastrointestinal Disorders Phase 3