What side effects are associated with this type of intervention?

Common treatments for Acute Lymphoblastic Leukemia (ALL) include chemotherapy, radiation therapy, and targeted therapy. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, increased risk of infections, and potential long-term effects like heart or liver damage. Radiation therapy may lead to skin changes, fatigue, and an increased risk of secondary cancers. Targeted therapies, which are designed to attack specific cancer cells, can cause side effects like diarrhea, liver problems, and skin rashes. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Lymphoblastic Leukemia (ALL), particularly focusing on pediatric-based regimens. These include drugs such as asparaginase, vincristine, and steroids, which are often used in combination protocols like COG AALL0232 and DFCI ALL 00-01. These regimens are designed to be more intensive and include components like delayed intensification and CNS prophylaxis, which have shown improved outcomes in children and adolescents with ALL.

What other types of research exist?

Promising novel alternatives to traditional infant nutrition for impacting the gut microbiome in Acute Lymphoblastic Leukemia patients include: 1) Probiotic-supplemented formulas, such as those containing Lactobacillus reuteri, which have shown efficacy in modifying gut microbiota and reducing colic symptoms. 2) Prebiotic-supplemented formulas, which can promote the growth of beneficial gut bacteria. 3) Synbiotic formulas, combining both probiotics and prebiotics, to synergistically enhance gut health. These alternatives can potentially support the gut microbiome and overall health in ALL patients undergoing treatment.

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Dietary Supplement

Enfamil NeuroPro for Infant Gut Health

N/A

Recruiting

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Use of donor breast milk

Parent unwillingness/inability to avoid giving prebiotics, probiotics, symbiotics, and immune-stimulating products to the child for the duration of this study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up birth to 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two types of baby formulas and breast milk in infants over a few months. It aims to see if adding specific ingredients to formula can make the gut bacteria similar to that of breastfed babies.

Who is the study for?

This trial is for healthy, full-term infants with parents who consent to participate. Parents must be able to give informed consent, own a smartphone, and complete weekly digital questionnaires. Infants born prematurely or via c-section, those with health issues at postpartum screening, or receiving prebiotics/probiotics/symbiotics/immune products are excluded.

What is being tested?

The study compares the gut bacteria in infants fed standard formula (Enfamil Infant), a new formula similar to breast milk (Enfamil NeuroPro), and breastfed infants. All formulas used meet FDA requirements and are commercially available.

What are the potential side effects?

Since both Enfamil Infant and Enfamil NeuroPro are FDA-approved formulas already on the market, significant side effects aren't expected. However, individual responses can vary; some babies might experience digestive changes when switching formulas.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am using or plan to use donor breast milk.

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I am willing and able to avoid giving my child certain supplements during this study.

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I use both breast milk and formula for feeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ birth to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~birth to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in microbial DNA in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.

Change from baseline in the gut metagenomics in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.

Change from baseline of metabolome in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.

Secondary study objectives

Growth- Head circumference

Growth- Height

Growth- Weight

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Enfamil InfantExperimental Treatment1 Intervention

Group II: Enfamil NeuroProActive Control1 Intervention

Group III: Breast MilkActive Control1 Intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Lymphoblastic Leukemia (ALL) include asparaginase, vincristine, steroids, and methotrexate. Asparaginase works by depleting the amino acid asparagine, which leukemia cells need to survive. Vincristine disrupts the formation of microtubules, inhibiting cell division. Steroids like prednisone induce apoptosis in leukemia cells. Methotrexate inhibits dihydrofolate reductase, blocking DNA synthesis and cell replication. These treatments are crucial for ALL patients as they target the rapid proliferation of leukemia cells, aiming to achieve remission and prevent relapse. While the trial on infant nutrition and gut microbiome focuses on different aspects, understanding the mechanisms of ALL treatments helps in comprehending their importance in managing the disease.