The Use of Cyproheptadine in Pediatric Feeding Disorders

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

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.

Study Overview

• Status: Completed
• Conditions: Avoidant Restrictive Food Intake Disorder; Pediatric Feeding Disorder, Chronic
• Intervention / Treatment: Behavioral: Nutritional Counseling; Behavioral: Behavioral Counseling; Drug: Cyproheptadine

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 30345
      • University of Miami Department of Pediatric Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional Counseling in Combination with Behavioral Counseling; Participants in the group will receive nutritional and behavioral counseling for up to 6 months	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.
Experimental: Cyproheptadine; Participants in this group will receive the Cyproheptadine for up to 6 months	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.; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight	Weight measured in kilograms	Baseline and up to 6 months
Change in height	Height measured in centimeters	Baseline and up to 6 months
Change in BMI	BMI measured in kg/m2	Baseline and up to 6 months
Change in BMI percentile	BMI measured in percent	Baseline and up to 6 months
Change in BMI Z-score	BMI measured in standard deviation units	Baseline and up to 6 months
Number of treatment related adverse events	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.	Up to 6 months
Parent's perception of medication's effects	Measured by Cyproheptadine Survey given to parents in yes/no format. Total sum of yes and no answers will be collected.	Up to 6 months

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Miguel Saps, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Malnutrition; Cyproheptadine
• Additional Relevant MeSH Terms: Organizing Pneumonia; Mental Disorders; Nutrition Disorders; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Feeding and Eating Disorders; Graft vs Host Disease; Nutritional and Metabolic Diseases; Avoidant Restrictive Food Intake Disorder; Bronchiolitis Obliterans Syndrome; Malnutrition; Health Care Quality, Access, and Evaluation; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Investigative Techniques; Epidemiologic Methods; Hydrocarbons; Hydrocarbons, Cyclic; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Piperidines; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Measurements; Dibenzocycloheptenes; Benzocycloheptenes; Cyproheptadine; Nutrition Assessment; Behavior Therapy
• Other Study ID Numbers: 20240756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No