PediaBerry for Hemangioma

(Pediaberry Trial)

No longer recruiting at 1 trial location

Overseen By Bryce Hockman, CCRP

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: Indiana University

Must not be taking: Beta blockers

Disqualifiers: Life-threatening hemangiomas, Congenital hemangiomas, Berry allergies, others

Compensation: Varies

Number of Visits: 12

Duration: 6 months

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

Who Is on the Research Team?

Gayle Gordillo, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

Inclusion Criteria

Hemangioma size ≥ 1 cm diameter

Infants younger than 4 months and 2 weeks, who have hemangiomas (abnormal growth of blood vessels) and were born prematurely.

Exclusion Criteria

Legal guardian unable to provide informed consent

You have hemangiomas (abnormal clusters of blood vessels) located in the diaper area, and the study product may get wiped off or contaminated during diaper changes.

Children who have had hemangiomas in the past and were treated for them.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive once daily topical and oral gavage dosing of PediaBerry or placebo for hemangioma treatment

6 months

6 visits (monthly, in-person)

Follow-up

Participants are monitored for signs of rebound hemangioma proliferation and other safety measures

12 months

5 visits (every other month until 12 months, then at 15 and 18 months)

What Are the Treatments Tested in This Trial?

Interventions

• PediaBerry

How Is the Trial Designed?

Group I: Pediaberry group Experimental Treatment 1 Intervention

PediaBerry™ is a proprietary blend powdered berry extracts

Group II: Placebo Placebo Group 1 Intervention

Placebo: powdered sugar plus McCormick Color from Nature Food Colors Berry and Sky Blue powdered food color (https://www.mccormick.com/spices-and-flavors/extracts-and-food-colors/food-colors/color-from-nature-assorted-food-color ).

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Gayle Gordillo

Lead Sponsor

Trials

6

Recruited

150+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04020419?term=berries%20AND%20cancer&viewType=Table&rank=7

Natural Berry Extract Treatment of Hemangiomas

This is a prospective, randomized, double-blind, placebo-controlled parallel group study evaluating the use of PediaBerry for the treatment of hemangiomas ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5467139/

Phytochemical Inhibition of Multidrug Resistance Protein-1 ...

EOMA cells treated with a blend of powdered natural berry extracts (NBE) significantly inhibited activity of multidrug resistance protein-1 (MRP-1) compared to ...

3.

ctv.veeva.com

ctv.veeva.com/study/natural-berry-extract-treatment-of-hemangiomas

Natural Berry Extract Treatment of Hemangiomas (Pediaberry)

This is a prospective, randomized, double-blind, placebo-controlled parallel group study evaluating the use of PediaBerry for the treatment ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7757590/

Mitochondria as Target for Tumor Management of ...

Our recent work has identified that a standardized anthocyanin-rich natural berry extract (NBE) is effective in prolonging survival of HE bearing mice (11). The ...

5.

aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04020419?keyword=%22Hemangioma%22

Natural Berry Extract Treatment of Hemangiomas

This is a prospective, randomized, double-blind, placebo-controlled parallel group study evaluating the use of PediaBerry for the treatment of hemangiomas ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04020419

Natural Berry Extract Treatment of Hemangiomas

This is a prospective, randomized, double-blind, placebo-controlled parallel group study evaluating the use of PediaBerry for the treatment of hemangiomas ...

7.

withpower.com

withpower.com/trial/early-phase-1-hemangioma-11-2020-e4958

Natural Berry Extract Treatment of Hemangiomas

The Pediaberry medical study, being run by Indiana University, needs participants to evaluate whether PediaBerry will have tolerable side effects & efficacy ...

8.

smartpatients.com

smartpatients.com/trials/NCT04020419

Natural Berry Extract Treatment of Hemangiomas

This is a prospective, randomized, double-blind, placebo-controlled parallel group study evaluating the use of PediaBerry for the treatment of hemangiomas.

9.

datamintelligence.com

datamintelligence.com/research-report/hemangioma-treatment-market

Hemangioma Treatment Market Size, Share, Industry ...

The aim of this clinical trial is to evaluate the use of PediaBerry for the treatment of hemangiomas in infants less than 4 months of corrected ...