Trials Today

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

Arm	Description	Assigned 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.