Advancing Nutritional Science for Children With Functional Dyspepsia

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.

Study Overview

• Status: Completed
• Conditions: Dyspepsia
• Intervention / Treatment: Other: Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Children's Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: NASPGHAN Foundation
• Investigators: Principal Investigator: Bruno Chumpitazi, MD, Baylor College Of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 6, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: H-44307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No