Active — Not RecruitingPhase 4

The Use of Cyproheptadine in Pediatric Feeding Disorders

United States50 participantsStarted 2024-12-30

Plain-language 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.

Who can participate

Age range2 Years – 6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Children's Eating Behavior Questionnaire score

Timeframe: Baseline and up to 6 months

Number of foods consumed by participants

Timeframe: Baseline and up to 6 months

Change in Child Food Neophobia score

Timeframe: Baseline and up to 6 months

Trial details

NCT IDNCT06751290

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

View on ClinicalTrials.gov More Pediatric Feeding Disorder, Chronic trials