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| Name | Class |
|---|---|
| NASPGHAN Foundation | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High fat/ Semi-solid | Active Comparator | Subject will receive a high fat/semi-solid meal. |
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| High carbohydrate/ Semi-solid | Active Comparator | Subject will receive a high carbohydrate/semi-solid meal. |
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| High fat/ solid | Active Comparator | Subject will receive a high fat/solid meal. |
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| High carbohydrate/ solid | Active Comparator | Subject will receive a high carbohydrate/solid meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Other | Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid |
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| Measure | Description | Time Frame |
|---|---|---|
| Dyspepsia Symptom Severity | Change from baseline gastrointestinal symptoms using total visual analogue scale score | up to 16 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Chumpitazi, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Nutrition Research Center | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Each subject will receive 4 meals of different composition.
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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.
| 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 |