NCT06751290

The Use of Cyproheptadine in Pediatric Feeding Disorders

The Use of Cyproheptadine to Improve Eating Habits in Children With Pediatric Feeding Disorders

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Feeding Disorder, Chronic
• Avoidant Restrictive Food Intake Disorder

Interventions

Type	Name	Description
DRUG	Cyproheptadine	Initiation of Cyproheptadine at 0.25mg/kg once daily by mouth at bedtime and titration up to at most three times daily as per participant's primary gastroenterologist.
BEHAVIORAL	Nutritional Counseling	This includes in person counseling by a provider once in office for up to 15 minutes as well as standardized hand out with basic nutritional guidance on high-calorie foods.
BEHAVIORAL	Behavioral Counseling	This includes in person counseling by a provider once in office for up to 15 minutes as well as standardized hand out with basic behavioral guidance.

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2024-12-27
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study