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Use of Intrapyloric Botulinum Injections in Children

Boston Children's Hospital logo

Boston Children's Hospital

Status

Unknown

Conditions

Vomiting
Gastroparesis
Feeding Disorders

Study type

Observational

Funder types

Other

Identifiers

NCT04250844
P00033019

Details and patient eligibility

About

This study aims to evaluate the effect of intrapyloric botulinum toxin in children with feeding disorders.

Full description

Chronic vomiting and feeding difficulties are common in young children and have a negative physical and psychosocial impact for patients and families. Currently there is no straightforward treatment algorithm for these issues, and management often involves multiple medication trials and procedures. Intrapyloric botulinum toxin injection has been proposed as a treatment for nausea and vomiting in adults, but there is minimal prior research on use in children and no prior research on use in children with feeding disorders. The aims of this study are: (1) to determine the efficacy of intrapyloric botulinum toxin injection for reducing gastrointestinal symptoms in children, (2) to determine the efficacy of intrapyloric botulinum injections for improving feeding outcomes in children, and (3) to define predictors of response to intrapyloric botulinum toxin injection.

Enrollment

100 estimated patients

Sex

All

Ages

30 days to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with chronic nausea, vomiting, or feeding intolerance undergoing upper endoscopy with or without intrapyloric botulinum injections.
  • Age between 30 days and 18 years.

Exclusion criteria

  • Significant uncontrolled inflammation on upper or lower endoscopy
  • Known inflammatory bowel disease
  • Uncontrolled thyroid disease
  • Current opioid use

Trial design

100 participants in 2 patient groups

Botulinum
Description:
We will follow for symptom improvement over time patients with nausea, vomiting, feeding intolerance, or other signs of gastric dysfunction who were determined by their gastroenterologist to require upper endoscopy with intrapyloric botulinum injections and if clinically applicable endoscopic functional luminal imaging probe (EndoFLIP). The dosage will be determined by the patient's physician.
Control
Description:
We will follow for symptom improvement over time patients with nausea, vomiting, feeding intolerance, or other signs of gastric dysfunction who were determined by their gastroenterologist to require upper endoscopy without intrapyloric botulinum injections.

Trial contacts and locations

1

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Central trial contact

Suzanna Hirsch, MD; Rachel Rosen, MD, MPH

Data sourced from clinicaltrials.gov

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