The Use of Cyproheptadine in Pediatric Feeding Disorders

University of Miami

Status and phase: Enrolling; Phase 4

Conditions: Avoidant Restrictive Food Intake Disorder; Pediatric Feeding Disorder, Chronic

Treatments: Behavioral: Nutritional Counseling; Drug: Cyproheptadine; Behavioral: Behavioral Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT06751290

20240756

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Nutritional Counseling in Combination with Behavioral Counseling

Experimental group

Description:

Participants in the group will receive nutritional and behavioral counseling for up to 6 months

Treatment:

Behavioral: Behavioral Counseling

Behavioral: Nutritional Counseling

Cyproheptadine

Experimental group

Description:

Participants in this group will receive the Cyproheptadine for up to 6 months

Treatment:

Behavioral: Behavioral Counseling

Drug: Cyproheptadine

Behavioral: Nutritional Counseling