Use of Intrapyloric Botulinum Injection… | Clinical Trial

Key information

Conditions

Vomiting Digestive System Diseases Feeding Disorders Feeding and Eating Disorders Gastrointestinal Diseases Gastroparesis Mental Disorders Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stomach Diseases

Age range

30 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Degree of improvement in quality of life

Time frame: 4 weeks

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.

Secondary outcomes

Degree of symptomatic improvement

Time frame: 4 weeks

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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2027
Study completion: 2027
First posted: Jan 31, 2020
Registry last updated: Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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