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Trial record 6 of 41 for:    Recruiting, Not yet recruiting, Available Studies | Dyspepsia

Advancing Nutritional Science for Children With Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT04053049
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
NASPGHAN Foundation
Information provided by (Responsible Party):
Bruno Chumpitazi, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Other: Diet Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each subject will receive 4 meals of different composition.
Masking: Double (Participant, Investigator)
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.
Primary Purpose: Other
Official Title: Advancing Nutritional Science for Children With Functional Dyspepsia
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Active Comparator: High fat/ Semi-solid
Subject will receive a high fat/semi-solid meal.
Other: Diet
Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid

Active Comparator: High carbohydrate/ Semi-solid
Subject will receive a high carbohydrate/semi-solid meal.
Other: Diet
Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid

Active Comparator: High fat/ solid
Subject will receive a high fat/solid meal.
Other: Diet
Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid

Active Comparator: High carbohydrate/ solid
Subject will receive a high carbohydrate/solid meal.
Other: Diet
Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid




Primary Outcome Measures :
  1. Dyspepsia Symptom Severity [ Time Frame: up to 16 weeks ]
    Change from baseline gastrointestinal symptoms using total visual analogue scale score


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053049


Contacts
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Contact: Deshara Watson 832-826-2271 deshara.emerson@bcm.edu
Contact: Bruno Chumpitazi, MD chumpita@bcm.edu

Locations
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United States, Texas
Children's Nutrition Research Center Recruiting
Houston, Texas, United States, 77030
Contact: Deshara Emerson       deshara.emerson@bcm.edu   
Contact       chumpita@bcm.edu   
Principal Investigator: Bruno Chumpitazi         
Sponsors and Collaborators
Baylor College of Medicine
NASPGHAN Foundation
Investigators
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Principal Investigator: Bruno Chumpitazi, MD Baylor College of Medicine

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Responsible Party: Bruno Chumpitazi, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04053049     History of Changes
Other Study ID Numbers: H-44307
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms