Advancing Nutritional Science for Children With Functional Dyspepsia
- Conditions
- Dyspepsia
- Interventions
- Other: Diet
- Registration Number
- NCT04053049
- Lead Sponsor
- Baylor College of Medicine
- Brief Summary
This study evaluates four different meals and how they induce gastrointestinal symptoms in children with functional dyspepsia. All subjects will receive each meal and rate their gastrointestinal symptoms during each meal.
- Detailed Description
Food can often exacerbate gastrointestinal symptoms in adults and children with functional dyspepsia. However, it is unclear which foods exacerbate symptoms more than others.
Children with post-prandial distress functional dyspepsia will receive four different meals with variables being: semi-solid vs. solid and high fat vs high carbohydrate. At the time of ingestion and for up to 3 hours after each meal, subjects will rate their gastrointestinal symptoms. Comparisons of symptom onset and severity will be made for each meal.
Enrolled subjects will have undergone previous gastrointestinal evaluations: gastric emptying study and/or upper endoscopy. In addition, subjects will complete psychosocial measures: Behavioral Assessment for Children-3, childhood somatization inventory.
The first goal is to compare the severity of gastrointestinal symptoms with different composition and consistency meals. The second goal is to correlate the severity of postprandial gastrointestinal symptoms to psychosocial distress, gastric neuromotor function (emptying and accommodation), and duodenal inflammation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Rome IV Functional Dyspepsia with post-prandial distress
- Previously completed normal upper endoscopy with duodenal biopsies and/or previously completed a gastric emptying scintigraphy study
- Previous abdominal surgery
- Current or previous formal psychiatric diagnosis (e.g. anxiety disorder) requiring therapy or psychotropics
- Serious chronic medical condition requiring regular medical care
- Allergy to meal components to be ingested during the study
- On specialized diet required for a medical condition
- Pregnancy
- Inability to eat by mouth
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description High fat/ solid Diet Subject will receive a high fat/solid meal. High fat/ Semi-solid Diet Subject will receive a high fat/semi-solid meal. High carbohydrate/ solid Diet Subject will receive a high carbohydrate/solid meal. High carbohydrate/ Semi-solid Diet Subject will receive a high carbohydrate/semi-solid meal.
- Primary Outcome Measures
Name Time Method Dyspepsia Symptom Severity up to 16 weeks Change from baseline gastrointestinal symptoms using total visual analogue scale score
- Secondary Outcome Measures
Name Time Method Gastric accommodation up to 16 weeks Gastric accommodation will be determined from a previously completed 4-hour gastric scintigraphy study using analysis of the time zero image.
Dyspepsia Symptom Onset up to 16 weeks Time to maximum symptom severity
Psychosocial distress up to 16 weeks Anxiety, Depression, and Somatization will be determined using Behavioral Assessment for Children-3 (t-scores for anxiety and depression) and Children's Somatization Inventory Score (total score).
Duodenal inflammation up to 16 weeks Previously obtained duodenal mucosal biopsies will be re-evaluated for eosinophils and mast cells
Gastric retention up to 16 weeks Gastric retention values will be captured from a previously completed 4-hour gastric emptying scintigraphy study
Trial Locations
- Locations (1)
Children's Nutrition Research Center
🇺🇸Houston, Texas, United States