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Completed

NCT Number: NCT06751290

The Use of Cyproheptadine in 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.

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Key information

Conditions

Pediatric Feeding Disorder, Chronic Avoidant Restrictive Food Intake Disorder Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Feeding and Eating Disorders Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Malnutrition Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Organizing Pneumonia Respiratory Tract Diseases

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami Department of Pediatric Gastroenterology

Miami, Florida, 30345, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyproheptadine

Drug

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.

Nutritional counseling

Behavioral

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 Counseling

Behavioral

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.

Primary outcomes

  1. Change in Children's Eating Behavior Questionnaire score

    Time frame: 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.

  2. Number of foods consumed by participants

    Time frame: 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.

  3. Change in Child Food Neophobia score

    Time frame: Baseline and up to 6 months

    Score of 10-70 with higher score indicating higher neophobia.

Secondary outcomes

  1. Change in weight

    Time frame: Baseline and up to 6 months

    Weight measured in kilograms

  2. Change in height

    Time frame: Baseline and up to 6 months

    Height measured in centimeters

  3. Change in BMI

    Time frame: Baseline and up to 6 months

    BMI measured in kg/m2

  4. Change in BMI percentile

    Time frame: Baseline and up to 6 months

    BMI measured in percent

  5. Change in BMI Z-score

    Time frame: Baseline and up to 6 months

    BMI measured in standard deviation units

  6. Number of treatment related adverse events

    Time frame: 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.

  7. Parent's perception of medication's effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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