Advancing Nutritional Science for Children With Functional Dyspepsia
Primary Purpose
Dyspepsia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet
Sponsored by
About this trial
This is an interventional other trial for Dyspepsia
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
Sites / Locations
- Children's Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
High fat/ Semi-solid
High carbohydrate/ Semi-solid
High fat/ solid
High carbohydrate/ solid
Arm Description
Subject will receive a high fat/semi-solid meal.
Subject will receive a high carbohydrate/semi-solid meal.
Subject will receive a high fat/solid meal.
Subject will receive a high carbohydrate/solid meal.
Outcomes
Primary Outcome Measures
Dyspepsia Symptom Severity
Change from baseline gastrointestinal symptoms using total visual analogue scale score
Secondary Outcome Measures
Dyspepsia Symptom Onset
Time to maximum symptom severity
Duodenal inflammation
Previously obtained duodenal mucosal biopsies will be re-evaluated for eosinophils and mast cells
Gastric retention
Gastric retention values will be captured from a previously completed 4-hour gastric emptying scintigraphy study
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).
Gastric accommodation
Gastric accommodation will be determined from a previously completed 4-hour gastric scintigraphy study using analysis of the time zero image.
Full Information
NCT ID
NCT04053049
First Posted
May 3, 2019
Last Updated
March 6, 2022
Sponsor
Baylor College of Medicine
Collaborators
NASPGHAN Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04053049
Brief Title
Advancing Nutritional Science for Children With Functional Dyspepsia
Official Title
Advancing Nutritional Science for Children With Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
NASPGHAN Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each subject will receive 4 meals of different composition.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High fat/ Semi-solid
Arm Type
Active Comparator
Arm Description
Subject will receive a high fat/semi-solid meal.
Arm Title
High carbohydrate/ Semi-solid
Arm Type
Active Comparator
Arm Description
Subject will receive a high carbohydrate/semi-solid meal.
Arm Title
High fat/ solid
Arm Type
Active Comparator
Arm Description
Subject will receive a high fat/solid meal.
Arm Title
High carbohydrate/ solid
Arm Type
Active Comparator
Arm Description
Subject will receive a high carbohydrate/solid meal.
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid
Primary Outcome Measure Information:
Title
Dyspepsia Symptom Severity
Description
Change from baseline gastrointestinal symptoms using total visual analogue scale score
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
Dyspepsia Symptom Onset
Description
Time to maximum symptom severity
Time Frame
up to 16 weeks
Title
Duodenal inflammation
Description
Previously obtained duodenal mucosal biopsies will be re-evaluated for eosinophils and mast cells
Time Frame
up to 16 weeks
Title
Gastric retention
Description
Gastric retention values will be captured from a previously completed 4-hour gastric emptying scintigraphy study
Time Frame
up to 16 weeks
Title
Psychosocial distress
Description
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).
Time Frame
up to 16 weeks
Title
Gastric accommodation
Description
Gastric accommodation will be determined from a previously completed 4-hour gastric scintigraphy study using analysis of the time zero image.
Time Frame
up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Chumpitazi, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Nutrition Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Advancing Nutritional Science for Children With Functional Dyspepsia
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