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Use of Intrapyloric Botulinum Injections in Children

NCT ID: NCT04250844

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2021-05-31

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.

Conditions

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Vomiting Feeding Disorders Gastroparesis

Keywords

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Botulinum Toxin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Botulinum

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.

No interventions assigned to this group

Control

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.

No interventions assigned to this group

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
Minimum Eligible Age

30 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rachel Rosen

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Rosen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Suzanna Hirsch, MD

Role: CONTACT

Phone: 617-355-6058

Email: [email protected]

Rachel Rosen, MD, MPH

Role: CONTACT

Email: [email protected]

Facility Contacts

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Suzanna Hirsch, MD

Role: primary

Other Identifiers

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P00033019

Identifier Type: -

Identifier Source: org_study_id