Children's Nutrition Research Center
Houston, Texas, 77030, United States
NCT Number: NCT04053049
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.
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Notify Me10 year–17 year
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid
Time frame: up to 16 weeks
Change from baseline gastrointestinal symptoms using total visual analogue scale score
Time frame: up to 16 weeks
Time to maximum symptom severity
Time frame: up to 16 weeks
Previously obtained duodenal mucosal biopsies will be re-evaluated for eosinophils and mast cells
Time frame: up to 16 weeks
Gastric retention values will be captured from a previously completed 4-hour gastric emptying scintigraphy study
Time frame: 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).
Time frame: 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.
Baylor College of Medicine
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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