The Use of Cyproheptadine in Pediatric Feeding Disorders

Purpose

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

Eligibility

Eligible Ages
Between 2 Years and 6 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • 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.

Recruiting Locations

University of Miami Department of Pediatric Gastroenterology
Miami, Florida 30345
Contact:
Taronda Bloom
305-243-6426
tjb129@med.miami.edu

More Details

NCT ID
NCT06751290
Status
Recruiting
Sponsor
University of Miami

Study Contact

Antonia Rovira, MD
3052433166
acr148@miami.edu

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center