Use of Intrapyloric Botulinum Injections in Children

Vomiting Clinical Trial

Official title:

Use of Intrapyloric Botulinum Injections in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04250844
• Other study ID #: P00033019
• Status: Recruiting
• Start date: March 10, 2020
• Est. completion date: May 2021

Study information

• Verified date: December 2020
• Source: Boston Children's Hospital
• Contact: Suzanna Hirsch, MD
• Phone: 617-355-6058
• Email: suzanna.hirsch[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding Disorders
• Gastroparesis
• Vomiting

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of improvement in quality of life	Quality of life will be measured with the Pediatric Quality of Life Inventory (PedsQL). This is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Each item is answered using a 3-point scale: 0 (Not at all), 2 (Sometimes), 4 (A lot). Scores range 0 to 100, with lower scores indicating worse quality of life. The outcome will be assessed by calculating the change in score from baseline to 4 weeks.	4 weeks
Secondary	Degree of symptomatic improvement	Symptoms will be measured with the Gastroparesis Cardinal Symptom Index (GCSI). The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). A six-point Likert response scale, ranging from 0 (none) to 5 (very severe) is used to rate severity of each symptom. Scores range from 0 to 45, with higher scores indicating worse symptoms. This outcome will be assess by calculating the change in score from baseline to 4 weeks.	4 weeks