Advancing Nutritional Science for Children With Functional Dyspepsia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Advancing Nutritional Science for Children With Functional Dyspepsia

Conditions
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Dyspepsia

Intervention / Treatment
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* Other: Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each subject will receive 4 meals of different composition.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High fat/ Semi-solid<br>Subject will receive a high fat/semi-solid meal. | Other: Diet<br>* Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid<br>|
| Active Comparator: High carbohydrate/ Semi-solid<br>Subject will receive a high carbohydrate/semi-solid meal. | Other: Diet<br>* Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid<br>|
| Active Comparator: High fat/ solid<br>Subject will receive a high fat/solid meal. | Other: Diet<br>* Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid<br>|
| Active Comparator: High carbohydrate/ solid<br>Subject will receive a high carbohydrate/solid meal. | Other: Diet<br>* Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspepsia Symptom Severity | Change from baseline gastrointestinal symptoms using total visual analogue scale score | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspepsia Symptom Onset | Time to maximum symptom severity | up to 16 weeks | 
| Duodenal inflammation | Previously obtained duodenal mucosal biopsies will be re-evaluated for eosinophils and mast cells | up to 16 weeks | 
| Gastric retention | Gastric retention values will be captured from a previously completed 4-hour gastric emptying scintigraphy study | up to 16 weeks | 
| Psychosocial distress | 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). | up to 16 weeks | 
| Gastric accommodation | Gastric accommodation will be determined from a previously completed 4-hour gastric scintigraphy study using analysis of the time zero image. | up to 16 weeks |