Advancing Nutritional Science for Children With Functional Dyspepsia

NCT04053049 | Completed

• 1 other identifier: H-44307
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Dyspepsia Symptom Severity

  Change from baseline gastrointestinal symptoms using total visual analogue scale score

  up to 16 weeks

Secondary Outcomes (5)

• Dyspepsia Symptom Onset

  up to 16 weeks

• Duodenal inflammation

  up to 16 weeks

• Gastric retention

  up to 16 weeks

• Psychosocial distress

  up to 16 weeks

• Gastric accommodation

  up to 16 weeks

Study Arms (4)

High fat/ Semi-solid

ACTIVE COMPARATOR

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

Other: Diet

High carbohydrate/ Semi-solid

ACTIVE COMPARATOR

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

Other: Diet

High fat/ solid

ACTIVE COMPARATOR

Subject will receive a high fat/solid meal.

Other: Diet

High carbohydrate/ solid

ACTIVE COMPARATOR

Subject will receive a high carbohydrate/solid meal.

Other: Diet

Interventions

Diet OTHER

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

High carbohydrate/ Semi-solid; High carbohydrate/ solid; High fat/ Semi-solid; High fat/ solid

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• NASPGHAN Foundation: collaborator

Study Sites (1)

Children's Nutrition Research Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Diet

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Bruno Chumpitazi, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Meals will be provided in a randomized fashion with only the metabolic research unit kitchen (which prepares the meals) knowing what is being provided to the subject.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Each subject will receive 4 meals of different composition.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: August 12, 2019
• Study Start: August 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)