Clinical trial NCT04053049: Advancing Nutritional Science for Children With Functional Dyspepsia
Official title: Advancing Nutritional Science for Children With Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspepsia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: NASPGHAN Foundation
First posted: 2019-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each subject will receive 4 meals of different composition.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dyspepsia Symptom Severity
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Dyspepsia Symptom Onset
timeFrame: up to 16 weeks
measure: Duodenal inflammation
timeFrame: up to 16 weeks
measure: Gastric retention
timeFrame: up to 16 weeks
measure: Psychosocial distress
timeFrame: up to 16 weeks
measure: Gastric accommodation
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Nutrition Research Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Bruno Chumpitazi, MD
role: PRINCIPAL_INVESTIGATOR
References: