The Use of Cyproheptadine in Pediatric Feeding Disorders

NCT06751290 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 20240756
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Feeding Disorder, Chronic; Avoidant Restrictive Food Intake Disorder

Keywords

Cyproheptadine; Malnutrition

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Change in weight

  Baseline and up to 6 months

• Change in height

  Baseline and up to 6 months

• Change in BMI

  Baseline and up to 6 months

• Change in BMI percentile

  Baseline and up to 6 months

• Change in BMI Z-score

  Baseline and up to 6 months

Study Arms (2)

Nutritional Counseling in Combination with Behavioral Counseling

EXPERIMENTAL

Participants in the group will receive nutritional and behavioral counseling for up to 6 months

Behavioral: Nutritional Counseling; Behavioral: Behavioral Counseling

Cyproheptadine

EXPERIMENTAL

Participants in this group will receive the Cyproheptadine for up to 6 months

Drug: Cyproheptadine; Behavioral: Nutritional Counseling; Behavioral: Behavioral Counseling

Interventions

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.

Cyproheptadine

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.

Cyproheptadine; Nutritional Counseling in Combination with Behavioral Counseling

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.

Cyproheptadine; Nutritional Counseling in Combination with Behavioral Counseling

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Department of Pediatric Gastroenterology

Miami, Florida, 30345, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Avoidant Restrictive Food Intake Disorder; Malnutrition

Interventions

Cyproheptadine; Nutrition Assessment; Behavior Therapy

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Feeding and Eating Disorders; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Miguel Saps, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: December 27, 2024
• Study Start: December 30, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)