PediaBerry for Hemangioma
(Pediaberry Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a natural berry extract called PediaBerry to determine its effectiveness in treating hemangiomas (a type of benign blood vessel growth) in infants. The study will compare PediaBerry with a placebo over six months, monitoring infants until they reach 18 months of age. Babies with hemangiomas larger than 1 cm, who are less than 4 months and 2 weeks old, may qualify if their hemangiomas are not life-threatening or located in sensitive areas like the diaper region. As an Early Phase 1 trial, this study aims to understand how PediaBerry works in infants, offering the opportunity to be among the first to receive this new treatment.
Do I need to stop my child's current medications for the trial?
The trial information does not specify if you need to stop your child's current medications. However, if the child is breastfeeding and the mother is taking beta blocker medication, they cannot participate.
Is there any evidence suggesting that PediaBerry is likely to be safe for infants?
Research is investigating PediaBerry, a berry-based blend, to determine its safety in treating hemangiomas—non-cancerous tumors made of blood vessels—in babies. As this is an early study, limited safety information is available for this use. However, early trials closely monitor for side effects. Researchers carefully observe how well babies tolerate PediaBerry and any adverse reactions. While detailed safety data is not yet available, the study aims to quickly identify and address potential issues.12345
Why do researchers think this study treatment might be promising?
Unlike traditional treatments for hemangiomas, which often involve laser therapy or beta-blockers like propranolol, PediaBerry is derived from natural berry extracts. Researchers are excited about PediaBerry because it offers a potentially gentler, more natural approach to treating these benign tumors. The unique formulation harnesses the power of antioxidants found in berries, which may target the hemangiomas without the side effects associated with more conventional treatments. This innovative approach could provide an effective alternative for patients seeking a natural option.
What evidence suggests that PediaBerry might be an effective treatment for hemangiomas?
Research suggests that natural berry extracts might help treat hemangiomas, which are harmless tumors resembling birthmarks. Studies have shown that these extracts can block a protein called multidrug resistance protein-1 (MRP-1), which can hinder tumor treatment by expelling drugs from cells. One study found that berry extracts high in anthocyanins, a type of antioxidant, helped mice with tumors live longer by affecting the mitochondria, the cell's energy centers. This trial examines the effectiveness of PediaBerry, a proprietary blend of powdered berry extracts, specifically for hemangiomas in infants.26789
Who Is on the Research Team?
Gayle Gordillo, MD
Principal Investigator
Indiana University
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive once daily topical and oral gavage dosing of PediaBerry or placebo for hemangioma treatment
Follow-up
Participants are monitored for signs of rebound hemangioma proliferation and other safety measures
What Are the Treatments Tested in This Trial?
Interventions
- PediaBerry
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Gayle Gordillo
Lead Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
National Institutes of Health (NIH)
Collaborator