Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia

University of Miami

Status: Withdrawn

Conditions: Gastroparesis; Dyspepsia

Treatments: Other: Gastric emptying breath test; Other: Stomach ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT05055336

20210662

Details and patient eligibility

About

The purpose of this research is to further study the relationship between gastroparesis (GP) (a condition in which the stomach cannot empty itself of food in a normal fashion) and functional dyspepsia (FD) (frequent symptoms of indigestion that have no obvious cause).

Sex: All

Ages: 5 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able to complete the Pediatric Cardinal Symptoms Questionnaire
• Both parent and child must be able to speak and understand English or Spanish

Exclusion criteria

• Have global developmental delay, autism disorder, or psychosis
• Are nonverbal and/or illiterate
• Lack fluency in English or Spanish
• Have other GI comorbidities such as inflammatory bowel disease, celiac disease, eosinophilic esophagitis, peptic ulcer disease, GI malignancy, or gastroesophageal reflux disease responsive to medications (medical records will be reviewed to detect these exclusions)
• Have a history of surgical procedures that could have potentially affected their GI tract anatomy, such as fundoplication or Ladd's procedure.
• Healthy child presenting to their well child care visit must not report a history of dyspepsia, have a history of any gastrointestinal disease, or be taking any medication that can disturb the GI tract motility.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 3 patient groups

Gastroparesis

Experimental group

Description:

Participants in this group are children diagnosed with gastroparesis per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.

Treatment:

Other: Stomach ultrasound

Other: Gastric emptying breath test

Dyspepsia

Experimental group

Description:

Participants in this group are children diagnosed with functional dyspepsia per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.

Treatment:

Other: Stomach ultrasound

Other: Gastric emptying breath test

Healthy Controls

Experimental group

Description:

Participants in this group are children that do not have gastroparesis, functional dyspepsia, or any other gastroenterology condition. Participants will be getting an ultrasound once.

Treatment:

Other: Stomach ultrasound