Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04250844
Study type Observational
Source Boston Children's Hospital
Contact Suzanna Hirsch, MD
Phone 617-355-6058
Email suzanna.hirsch@childrens.harvard.edu
Status Recruiting
Phase
Start date March 10, 2020
Completion date May 2021

See also
  Status Clinical Trial Phase
Completed NCT00358813 - Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment Phase 1
Recruiting NCT03851835 - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis Phase 3
Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy Phase 1
Terminated NCT01975727 - Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting Phase 2
Completed NCT02939287 - Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan Phase 3
Not yet recruiting NCT06464926 - Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE) N/A
Completed NCT02462811 - A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV) Phase 3
Recruiting NCT01966406 - Is Nasogastric Tube Necessary After Pancreaticoduodenectomy? N/A
Completed NCT01007500 - Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery Phase 4
Recruiting NCT00528554 - Laser Acupuncture Against Nausea in Children N/A
Completed NCT00537875 - Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens N/A
Completed NCT00394966 - A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED) Phase 2
Completed NCT00177333 - Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens Phase 4
Completed NCT00946387 - To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions Phase 1
Completed NCT00947128 - To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions Phase 1
Not yet recruiting NCT04827108 - Psychometric Properties of the Chinese Version of PeNAT
Not yet recruiting NCT04853303 - VR to Improve CINV, Sleep and Pain Among Children With Cancer in HK N/A
Recruiting NCT03679182 - Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care Phase 2
Terminated NCT01405924 - Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030) Phase 2
Recruiting NCT04116697 - A Randomized Controlled Trial to Evaluate the Efficacy of Acupuncture Versus Aromatherapy as Treatments to Lessen Nausea, Vomiting and Anxiety Associated With Adriamycin and Cytoxan N/A