Advancing Nutritional Science for Children With Functional Dyspepsia

Baylor College of Medicine

Status: Completed

Conditions: Dyspepsia

Treatments: Other: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04053049

H-44307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 4 patient groups

High fat/ Semi-solid

Active Comparator group

Description:

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

Treatment:

Other: Diet

High carbohydrate/ Semi-solid

Active Comparator group

Description:

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

Treatment:

Other: Diet

High fat/ solid

Active Comparator group

Description:

Subject will receive a high fat/solid meal.

Treatment:

Other: Diet

High carbohydrate/ solid

Active Comparator group

Description:

Subject will receive a high carbohydrate/solid meal.

Treatment:

Other: Diet