Pediatric Feeding Disorder, ChronicPhase 4NCT06751290
The Use of Cyproheptadine in Pediatric Feeding Disorders
A Phase 4 study testing Cyproheptadine, Nutritional Counseling and Behavioral Counseling in people with Pediatric Feeding Disorder, Chronic and Avoidant Restrictive Food Intake Disorder, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Pediatric Feeding Disorder, Chronic, Avoidant Restrictive Food Intake Disorder
- What is being tested?
- Cyproheptadine, Nutritional Counseling and Behavioral Counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2024to 30 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Department of Pediatric Gastroenterology
Miami, Florida, 30345
About this study
Official title: The Use of Cyproheptadine to Improve Eating Habits in Children With Pediatric Feeding Disorders
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.
- Being tested
- Cyproheptadine, Nutritional Counseling, Behavioral Counseling
- Keywords
- Cyproheptadine, Malnutrition
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Avoidant Restrictive Food Intake Disorder, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyproheptadineDrug
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 CounselingBehavioural
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 CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Counseling in Combination with Behavioral Counseling | Experimental | Participants in the group will receive nutritional and behavioral counseling for up to 6 months Receives: Behavioral: Nutritional Counseling; Behavioral: Behavioral Counseling |
| Cyproheptadine | Experimental | Participants in this group will receive the Cyproheptadine for up to 6 months Receives: Drug: Cyproheptadine; Behavioral: Nutritional Counseling; Behavioral: Behavioral Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and up to 6 months
Change in Child Food Neophobia score
Score of 10-70 with higher score indicating higher neophobia.
Measured: Baseline and up to 6 months
Secondary outcomes (7)
Change in weight
Weight measured in kilograms
Measured: Baseline and up to 6 months
Change in height
Height measured in centimeters
Measured: Baseline and up to 6 months
Change in BMI
BMI measured in kg/m2
Measured: Baseline and up to 6 months
Change in BMI percentile
BMI measured in percent
Measured: Baseline and up to 6 months
Change in BMI Z-score
BMI measured in standard deviation units
Measured: Baseline and up to 6 months
Number of treatment related adverse events
Number of treatment related adverse events using the National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5 as per physician discretion.
Measured: Up to 6 months
Parent's perception of medication's effects
Measured by Cyproheptadine Survey given to parents in yes/no format. Total sum of yes and no answers will be collected.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start30 Dec 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Feeding Disorder, ChronicStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Saps, University of Miami
- Investigators
- Miguel Saps, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751290
- Sponsor's protocol ID
- 20240756
- Status last verified
- Jun 2026
- First submitted
- 31 Oct 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Cyproheptadine to Improve Eating Habits in Children With Pediatric Feeding Disorders
- ClinicalTrials.gov ID
- NCT06751290
- Acronym / sponsor ID
- 20240756
- Keywords
- Cyproheptadine, Malnutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Counseling in Combination with Behavioral Counseling | Experimental | Behavioral: Nutritional Counseling, Behavioral: Behavioral CounselingParticipants in the group will receive nutritional and behavioral counseling for up to 6 months |
| Cyproheptadine | Experimental | Drug: Cyproheptadine, Behavioral: Nutritional Counseling, Behavioral: Behavioral CounselingParticipants in this group will receive the Cyproheptadine for up to 6 months |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyproheptadineInitiation 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. | Drug | Cyproheptadine |
| Nutritional CounselingThis 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. | Behavioural | Cyproheptadine, Nutritional Counseling in Combination with Behavioral Counseling |
| Behavioral CounselingThis 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. | Behavioural | Cyproheptadine, Nutritional Counseling in Combination with Behavioral Counseling |
Primary outcome
Change in Children's Eating Behavior Questionnaire score
Time frame: Baseline and up to 6 months
A composite score will be obtained and scores range from 1-5 with higher scores indicating more behavioral eating.
Number of foods consumed by participants
Time frame: Baseline and up to 6 months
Number of food consumed will be collected. Number of foods consumed as defined as eaten more than once per month.
Change in Child Food Neophobia score
Time frame: Baseline and up to 6 months
Score of 10-70 with higher score indicating higher neophobia.
7 secondary outcomes
Change in weight
Time frame: Baseline and up to 6 months
Change in height
Time frame: Baseline and up to 6 months
Change in BMI
Time frame: Baseline and up to 6 months
Change in BMI percentile
Time frame: Baseline and up to 6 months
Change in BMI Z-score
Time frame: Baseline and up to 6 months
Number of treatment related adverse events
Time frame: Up to 6 months
Parent's perception of medication's effects
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Saps, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyproheptadine, Nutritional Counseling and Behavioral Counseling in people with Pediatric Feeding Disorder, Chronic and Avoidant Restrictive Food Intake Disorder, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Children's Eating Behavior Questionnaire score (time frame: Baseline and up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.