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

Trial Summary

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 data supports the effectiveness of the drug Cyproheptadine for pediatric feeding disorders?

Research shows that Cyproheptadine can help improve feeding difficulties and poor growth in young children, as it acts as an appetite stimulant. It has been used successfully to treat feeding intolerance and vomiting in children under three years old, and it has shown positive effects on growth in underweight children. ^{1 2 3 4 5}

Is cyproheptadine safe for use in children?

Cyproheptadine is generally considered safe, but it can cause mild side effects like drowsiness and, rarely, liver issues. It's important to monitor for these effects, especially in young children, and more studies are needed to fully understand its safety in this age group. ^{1 2 4 6 7}

How is the drug cyproheptadine unique for treating pediatric feeding disorders?

Cyproheptadine is unique because it acts as an appetite stimulant and has antihistaminergic, antiserotonergic, and anticholinergic effects, which can help increase gastric accommodation (the stomach's ability to hold food) and improve feeding tolerance in young children. ^{1 2 3 4 8}

What is the purpose of this trial?

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.

Research Team

Miguel Saps, MD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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 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]

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]

References

1. Norway 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Use of cyproheptadine in young children with feeding difficulties and poor growth in a pediatric feeding program. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of cyproheptadine for treating dyspeptic symptoms in children. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Short-term cyproheptadine therapy in underweight children: effects on growth and serum insulin-like growth factor-I. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Cyproheptadine is an effective appetite stimulant in cystic fibrosis. [2013]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Cyproheptadine, an Orexigenic Drug. Analysis of the French National Pharmacovigilance Data-Base and Systematic Review. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

[Toxicity of cyproheptadine. Side effects and accidental overdosage (author's transl)]. [2014]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Beneficial effect of cyproheptadine on body mass index in undernourished children: a randomized controlled trial. [2020]