Advancing Nutritional Science for Children With Functional Dyspepsia

Dyspepsia Clinical Trial

Official title:

Advancing Nutritional Science for Children With Functional Dyspepsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04053049
• Other study ID #: H-44307
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2022
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Other:
• Diet
Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid

Locations

Country	Name	City	State
United States	Children's Nutrition Research Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	NASPGHAN Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspepsia Symptom Severity	Change from baseline gastrointestinal symptoms using total visual analogue scale score	up to 16 weeks
Secondary	Dyspepsia Symptom Onset	Time to maximum symptom severity	up to 16 weeks
Secondary	Duodenal inflammation	Previously obtained duodenal mucosal biopsies will be re-evaluated for eosinophils and mast cells	up to 16 weeks
Secondary	Gastric retention	Gastric retention values will be captured from a previously completed 4-hour gastric emptying scintigraphy study	up to 16 weeks
Secondary	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
Secondary	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