Advancing Nutritional Science for Children With Functional Dyspepsia

NCT ID: NCT04053049

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-12-01

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.

Conditions

Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

High fat/ Semi-solid

Subject will receive a high fat/semi-solid meal.

Group Type: ACTIVE_COMPARATOR

Diet

Intervention Type: OTHER

Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid

High carbohydrate/ Semi-solid

Subject will receive a high carbohydrate/semi-solid meal.

Group Type: ACTIVE_COMPARATOR

Diet

Intervention Type: OTHER

Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid

High fat/ solid

Subject will receive a high fat/solid meal.

Group Type: ACTIVE_COMPARATOR

Diet

Intervention Type: OTHER

Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid

High carbohydrate/ solid

Subject will receive a high carbohydrate/solid meal.

Group Type: ACTIVE_COMPARATOR

Diet

Intervention Type: OTHER

Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid

Interventions

Diet

Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NASPGHAN Foundation

OTHER_GOV

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Bruno Chumpitazi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruno Chumpitazi, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Children's Nutrition Research Center

Houston, Texas, United States

Countries

United States

Other Identifiers

H-44307

Identifier Type: -

Identifier Source: org_study_id