Using Cyproheptadine to Help Children with Feeding Disorders
The Use of Cyproheptadine to Improve Eating Habits in Children With Pediatric Feeding Disorders
This study is testing if a medication called Cyproheptadine can help young children with feeding disorders eat better and gain weight.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06751290 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Cyproheptadine, an appetite stimulant, in improving eating habits among children aged 2-6 years diagnosed with Pediatric Feeding Disorders. Participants will receive Cyproheptadine along with nutritional and behavioral counseling to address issues related to poor weight gain and malnutrition. The study will assess changes in eating behaviors and overall health outcomes in these children. The trial is conducted at the University of Miami's Pediatric Gastroenterology Clinic.
Who should consider this trial
Good fit: Ideal candidates are children aged 2-6 years who exhibit poor weight gain or feeding issues and have been diagnosed with a pediatric feeding disorder.
Not a fit: Patients who are tube-fed, overweight, or have active gastrointestinal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the nutritional intake and health of children suffering from feeding disorders.
How similar studies have performed: While the use of appetite stimulants in pediatric feeding disorders is not extensively studied, there is some evidence suggesting potential benefits, making this approach promising yet somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Miami, Florida
- University of Miami Department of Pediatric Gastroenterology — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Miguel Saps, MD — University of Miami
- Study coordinator: Antonia Rovira, MD
- Email: acr148@miami.edu
- Phone: 3052433166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.