Dyspepsia
Conditions
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.
Interventions
OTHERDiet
Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid
Sponsors
NASPGHAN Foundation
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Meals will be provided in a randomized fashion with only the metabolic research unit kitchen (which prepares the meals) knowing what is being provided to the subject.
Intervention model description
Each subject will receive 4 meals of different composition.
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyspepsia Symptom Severity | up to 16 weeks | Change from baseline gastrointestinal symptoms using total visual analogue scale score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspepsia Symptom Onset | up to 16 weeks | Time to maximum symptom severity |
| 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 |
| 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). |
| 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. |
Countries
United States
Outcome results
None listed