The Use of Cyproheptadine in Pediatric Feeding Disorders

Phase 4

Recruiting

• Conditions: Pediatric Feeding Disorder, Chronic; Avoidant Restrictive Food Intake Disorder
• Interventions: Behavioral: Nutritional Counseling; Drug: Cyproheptadine; Behavioral: Behavioral Counseling

• Registration Number: NCT06751290
• Lead Sponsor: University of Miami

Brief Summary

The goal of this clinical trial is to learn if Cyproheptadine, an appetite stimulant, can improve eating habits in children with Pediatric Feeding Disorders. Pediatric Feeding Disorders is a broad term that describes disorders of eating-related behaviors that causes altered consumption of food and impairs physical or psychosocial health.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-27
• Study Start: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Any patient aged 2-6 years of age who presents to Pediatric Gastroenterology Clinic with complaint of "poor weight gain, malnutrition, failure to thrive/weight faltering, picky eating, or feeding issues" who screens positive for a pediatric feeding disorder using the Child eating disorder questionnaire (CEBQ)
• Age Range: 2-6 years
• English or Spanish speaking

Exclusion Criteria

• Patients who are tube fed
• Patients who are overweight (BMI at 85th%tile or greater)
• Patients who have active symptoms from a diagnosis of a GI disorder (Inflammatory Bowel Disease, Eosinophilic Esophagitis, Gastritis)
• Patients actively undergoing behavioral feeding therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional Counseling in Combination with Behavioral Counseling	Nutritional Counseling	Participants in the group will receive nutritional and behavioral counseling for up to 6 months
Nutritional Counseling in Combination with Behavioral Counseling	Behavioral Counseling	Participants in the group will receive nutritional and behavioral counseling for up to 6 months
Cyproheptadine	Cyproheptadine	Participants in this group will receive the Cyproheptadine for up to 6 months
Cyproheptadine	Nutritional Counseling	Participants in this group will receive the Cyproheptadine for up to 6 months
Cyproheptadine	Behavioral Counseling	Participants in this group will receive the Cyproheptadine for up to 6 months

Primary Outcome Measures

Name	Time	Method
Change in Children's Eating Behavior Questionnaire score	Baseline and up to 6 months	A composite score will be obtained and scores range from 1-5 with higher scores indicating more behavioral eating.
Number of foods consumed by participants	Baseline and up to 6 months	Number of food consumed will be collected. Number of foods consumed as defined as eaten more than once per month.
Change in Child Food Neophobia score	Baseline and up to 6 months	Score of 10-70 with higher score indicating higher neophobia.

Secondary Outcome Measures

Name	Time	Method
Change in weight	Baseline and up to 6 months	Weight measured in kilograms
Change in height	Baseline and up to 6 months	Height measured in centimeters
Change in BMI	Baseline and up to 6 months	BMI measured in kg/m2
Change in BMI percentile	Baseline and up to 6 months	BMI measured in percent
Change in BMI Z-score	Baseline and up to 6 months	BMI measured in standard deviation units
Number of treatment related adverse events	Up to 6 months	Number of treatment related adverse events using the National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5 as per physician discretion.
Parent's perception of medication's effects	Up to 6 months	Measured by Cyproheptadine Survey given to parents in yes/no format. Total sum of yes and no answers will be collected.

Trial Locations

Locations (1)

University of Miami Department of Pediatric Gastroenterology; 🇺🇸 Miami, Florida, United States