Cyproheptadine for Pediatric Feeding Disorders

Overseen By Antonia Rovira, MD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Disqualifiers: Tube fed, Overweight, GI disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Cyproheptadine, a medication that stimulates appetite, can improve eating in children with Pediatric Feeding Disorders. These disorders involve eating problems that can lead to poor nutrition and affect health. The trial includes two groups: one will receive nutritional and behavioral counseling, while the other will take Cyproheptadine for up to six months. The trial seeks children aged 2-6 who struggle with poor weight gain, picky eating, or similar feeding issues. As a Phase 4 trial, Cyproheptadine is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Cyproheptadine?

Research has shown that cyproheptadine is generally safe for children. It often aids children with growth difficulties by enhancing their appetite. Some mild side effects, such as sleepiness or dizziness, might occur. Reports of liver issues are rare, affecting fewer than 2 out of every 1,000 children. Overall, cyproheptadine is considered safe for young ones with feeding problems. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Cyproheptadine is unique because it offers a fresh approach to pediatric feeding disorders by acting as an appetite stimulant through its antihistamine properties. Unlike standard treatments, which often focus on nutritional supplements or behavioral therapies, Cyproheptadine directly targets the histamine receptors to boost appetite. Researchers are excited about this because it could provide a more direct and potentially quicker way to improve feeding habits in children who struggle with eating due to medical conditions. Additionally, combining Cyproheptadine with nutritional and behavioral counseling might enhance its effectiveness, offering a more comprehensive treatment strategy.

What evidence suggests that Cyproheptadine might be an effective treatment for Pediatric Feeding Disorders?

Studies have shown that cyproheptadine can improve eating habits in children with Pediatric Feeding Disorders. In one study, 96% of parents noticed positive changes in their child's mealtime and feeding behaviors after using cyproheptadine. Another review found that cyproheptadine helped stop vomiting and made eating easier for young children. This medication, known as an appetite booster, has been shown to help children gain weight and grow better. It is widely used and considered effective for children who have trouble eating. In this trial, participants will either receive cyproheptadine or undergo nutritional and behavioral counseling to assess the effectiveness of these approaches. ^{1 2 3 6 7}

Who Is on the Research Team?

Miguel Saps, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for children with Pediatric Feeding Disorders, which affect their eating habits and health. It's open to those who struggle with consuming enough food due to various eating-related behaviors.

Inclusion Criteria

My child is 2-6 years old with feeding or growth issues and tested positive for a feeding disorder.

I am between 2 and 6 years old.

Exclusion Criteria

I receive my nutrition through a feeding tube.

I am overweight according to BMI standards.

I have active symptoms from a GI disorder like IBD, EoE, or Gastritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cyproheptadine or nutritional and behavioral counseling for up to 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cyproheptadine

Trial Overview The study tests if Cyproheptadine, an appetite stimulant, can help improve the eating patterns of these children. The trial includes behavioral and nutritional counseling as part of the treatment process.

How Is the Trial Designed?

Group I: Nutritional Counseling in Combination with Behavioral Counseling Experimental Treatment 2 Interventions

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

Group II: Cyproheptadine Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

In a study of 89 children aged 24-64 months with mild to moderate undernutrition, cyproheptadine hydrochloride (CH) significantly increased body mass index (BMI) after four weeks of treatment compared to a control group, with a mean weight gain of 0.60 kg in the CH group versus 0.11 kg in the control group.

While CH improved BMI, there were no significant differences in weight and height velocity between the CH and control groups by the end of the study, suggesting that CH primarily affects BMI rather than overall growth rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effect of cyproheptadine on body mass index in undernourished children: a randomized controlled trial. Najib, K., Moghtaderi, M., Karamizadeh, Z., et al.[2020]

In a 12-week study involving 18 participants with cystic fibrosis, cyproheptadine hydrochloride (CH) significantly increased weight and other growth metrics compared to placebo, indicating its effectiveness as an appetite stimulant.

The treatment was well-tolerated with minimal side effects, primarily mild sedation, suggesting that CH can be a safe option to help improve nutritional status in individuals with cystic fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyproheptadine is an effective appetite stimulant in cystic fibrosis. Homnick, DN., Homnick, BD., Reeves, AJ., et al.[2013]

In a study of 127 infants and young children with poor growth, those who regularly received cyproheptadine (CY) showed significant improvements in weight-for-age z scores (WtZ) compared to their scores before treatment.

Parents reported positive changes in mealtime and feeding behaviors for 96% of the children treated with CY, indicating that it is a safe and effective option when combined with a specialized feeding program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of cyproheptadine in young children with feeding difficulties and poor growth in a pediatric feeding program. Sant'Anna, AM., Hammes, PS., Porporino, M., et al.[2022]

In a study of 21 underweight children, those treated with cyproheptadine for 4 months showed significantly greater increases in weight and height compared to those receiving a placebo.

Cyproheptadine therapy not only improved caloric intake but also increased serum IGF-I levels, which are important for growth, indicating its efficacy in promoting growth in underweight children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term cyproheptadine therapy in underweight children: effects on growth and serum insulin-like growth factor-I. Mahachoklertwattana, P., Wanasuwankul, S., Poomthavorn, P., et al.[2019]

A review of the French pharmacovigilance database revealed that cyproheptadine has a generally safe profile, with mild neurological effects being the most common adverse reactions, while serious liver complications are rare.

Despite its safety, there is a need for randomized controlled trials to further assess the efficacy and safety of cyproheptadine for stimulating appetite, particularly in children, as current studies are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Cyproheptadine, an Orexigenic Drug. Analysis of the French National Pharmacovigilance Data-Base and Systematic Review. Bertrand, V., Massy, N., Vegas, N., et al.[2021]

In a study of 80 children under 12 years old, cyproheptadine was found to be safe and effective in treating dyspeptic symptoms, with a 55% overall response rate, particularly benefiting young children and those experiencing early vomiting.

The medication was well-tolerated, with mild side effects reported in 30% of patients, and a high response rate of 86% in children with retching after fundoplication, indicating its potential as a treatment option for this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of cyproheptadine for treating dyspeptic symptoms in children. Rodriguez, L., Diaz, J., Nurko, S.[2021]

In a retrospective review of 39 children under three years old, cyproheptadine was found to be effective in resolving vomiting and improving feeding tolerance in 67% of the cases, indicating its potential as a treatment for feeding issues in this age group.

The medication was generally safe, with rare side effects like sleepiness and constipation, suggesting that it could be a viable option before considering more invasive testing for infants with feeding intolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective review of cyproheptadine for feeding intolerance in children less than three years of age: effects and side effects. Merhar, SL., Pentiuk, SP., Mukkada, VA., et al.[2022]

In a study of 113 cases of accidental cyproheptadine ingestion in children, no life-threatening effects were observed, even at doses ranging from 0.3 to 6.15 mg/kg, although symptoms like somnolence and tachycardia were common.

Cyproheptadine can significantly affect hormone levels and metabolism, but due to its considerable side effects, it should only be prescribed to children after careful consideration, especially for issues like lack of appetite.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Toxicity of cyproheptadine. Side effects and accidental overdosage (author's transl)]. von Mühlendahl, KE., Krienke, EG.[2014]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24941960/

Use of cyproheptadine in young children with feeding ... For these patients, the majority of the parents (96%) reported a positive change in mealtime and feeding behaviors. A significant improvement in mean WtZ was ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02568007

Effects of Cyproheptadine on Growth and Behavior in ... While a few studies report outcomes of the use of cyproheptadine in children with feeding disorders or failure to thrive, these studies have enrolled only small ...

3. withpower.com withpower.com/trial/cyproheptadine-for-pediatric-feeding-disorders-e63fc

Cyproheptadine for Pediatric Feeding Disorders In a retrospective review of 39 children under three years old, cyproheptadine was found to be effective in resolving vomiting and improving feeding tolerance ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1097/MPG.0000000000000467

Use of Cyproheptadine in Young Children With Feeding ... Overall, our results have demonstrated that a combined multidisciplinary approach and the use of an appetite stimulant can significantly improve ...

5. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2021.712413/full

Safety of Cyproheptadine, an Orexigenic Drug. Analysis ... Use of cyproheptadine in young children with feeding difficulties and poor growth in a pediatric feeding program. J Pediatr Gastroenterol ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8525494/

Safety of Cyproheptadine, an Orexigenic Drug. Analysis of the ... We estimated the frequency of hepatic adverse effects at 0.27 to 1.4/1000, regardless of age. Conclusion: Cyproheptadine can be considered a safe drug.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022347613000085

Safety and Efficacy of Cyproheptadine for Treating ... Conclusion. Cyproheptadine is safe and effective for treating dyspeptic symptoms in children, particularly in young children and those with early vomiting and ...