The Use of Cyproheptadine in Pediatric Feeding Disorders
NCT ID: NCT06751290
Last Updated: 2025-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2024-12-30
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nutritional Counseling in Combination with Behavioral Counseling
Participants in the group will receive nutritional and behavioral counseling for up to 6 months
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 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.
Cyproheptadine
Participants in this group will receive the Cyproheptadine for up to 6 months
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.
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 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.
Interventions
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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.
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 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.
Eligibility Criteria
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Inclusion Criteria
* Age Range: 2-6 years
* English or Spanish speaking
Exclusion Criteria
* 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
2 Years
6 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Miguel Saps
Professor of Clinical
Principal Investigators
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Miguel Saps, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami Department of Pediatric Gastroenterology
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20240756
Identifier Type: -
Identifier Source: org_study_id
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