Use of Intrapyloric Botulinum Injections in Children

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

Detailed Description
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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.

Official Title
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Use of Intrapyloric Botulinum Injections in Children

Conditions
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Vomiting, Feeding Disorders, Gastroparesis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Botulinum<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum Toxin