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Completed

NCT Number: NCT04053049

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.

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Nutrition Research Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Other

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

Primary outcomes

  1. Dyspepsia Symptom Severity

    Time frame: up to 16 weeks

    Change from baseline gastrointestinal symptoms using total visual analogue scale score

Secondary outcomes

  1. Dyspepsia Symptom Onset

    Time frame: up to 16 weeks

    Time to maximum symptom severity

  2. Duodenal inflammation

    Time frame: up to 16 weeks

    Previously obtained duodenal mucosal biopsies will be re-evaluated for eosinophils and mast cells

  3. Gastric retention

    Time frame: up to 16 weeks

    Gastric retention values will be captured from a previously completed 4-hour gastric emptying scintigraphy study

  4. Psychosocial distress

    Time frame: up to 16 weeks

    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).

  5. Gastric accommodation

    Time frame: up to 16 weeks

    Gastric accommodation will be determined from a previously completed 4-hour gastric scintigraphy study using analysis of the time zero image.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • NASPGHAN Foundation

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2019
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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