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Use of Intrapyloric Botulinum Injections in Children

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ClinicalTrials.gov Identifier: NCT04250844
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Rachel Rosen, Boston Children's Hospital

Brief Summary:
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.

Condition or disease
Vomiting Feeding Disorders Gastroparesis

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Intrapyloric Botulinum Injections in Children
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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.
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients from our tertiary care center who are undergoing upper endoscopy with or without intrapyloric botulinum injections.
Criteria

Inclusion Criteria:

  • Patients with chronic nausea, vomiting, or feeding intolerance undergoing upper endoscopy with or without intrapyloric botulinum injections.
  • Age between 30 days and 35 years.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250844


Contacts
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Contact: Suzanna Hirsch, MD 617-355-6058 suzanna.hirsch@childrens.harvard.edu
Contact: Rachel Rosen, MD, MPH rachel.rosen@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Suzanna Hirsch, MD       suzanna.hirsch@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children's Hospital
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Responsible Party: Rachel Rosen, Associate Professor of Pediatrics, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT04250844    
Other Study ID Numbers: P00033019
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rachel Rosen, Boston Children's Hospital:
Botulinum Toxin
Additional relevant MeSH terms:
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Gastroparesis
Vomiting
Feeding and Eating Disorders
Signs and Symptoms, Digestive
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Mental Disorders