The Use of Cyproheptadine in Pediatric Feeding Disorders

Last updated: January 15, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Cyproheptadine

Nutritional Counseling

Behavioral Counseling

Clinical Study ID

NCT06751290
20240756
  • Ages 2-6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any patient aged 2-6 years of age who presents to Pediatric Gastroenterology Clinicwith complaint of "poor weight gain, malnutrition, failure to thrive/weightfaltering, picky eating, or feeding issues" who screens positive for a pediatricfeeding disorder using the Child eating disorder questionnaire (CEBQ)

  • Age Range: 2-6 years

  • English or Spanish speaking

Exclusion

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 (InflammatoryBowel Disease, Eosinophilic Esophagitis, Gastritis)

  • Patients actively undergoing behavioral feeding therapy

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: Cyproheptadine
Phase: 4
Study Start date:
December 30, 2024
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • University of Miami Department of Pediatric Gastroenterology

    Miami, Florida 30345
    United States

    Active - Recruiting

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