New Organic Infant Formula for Healthy Growth

Not currently recruiting at 1 trial location

Overseen By Recruiting Support

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Bobbie Baby, Inc

Must not be taking: Prescription medications, Antibiotics

Disqualifiers: Medical complications, Failure to thrive, GI abnormalities, Congenital illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a new organic infant formula supports healthy growth in babies as effectively as existing cow's milk formulas. Researchers will compare babies fed with the new organic formula, a commercial formula, and those who are breastfed. The trial seeks healthy, full-term babies under 11 days old with a birth weight between 2.5 kg and 4.5 kg. The baby's caregiver must have already chosen to exclusively formula-feed or breastfeed and be willing to maintain that choice throughout the study. As an unphased trial, this study offers caregivers the chance to contribute to research that could enhance infant nutrition options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but infants receiving prescription medication are excluded from participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the safety of infant formulas can vary. Consumer Reports conducted a study testing 41 formulas for harmful chemicals like lead and arsenic, finding some with concerning levels. However, this study did not include results for the new organic infant formula. While infant formulas must meet strict regulations before sale, they do not receive FDA approval like medicines. For a formula to be considered safe, any contaminants should be present at very low levels.

When considering joining a trial, these findings are important to keep in mind. Always consult a healthcare professional for advice tailored to your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The New Organic Infant Formula is unique because it introduces an innovative blend of organic ingredients designed specifically for optimal infant growth and development. Unlike standard commercial formulas, which may include synthetic additives, this formula emphasizes natural and organic components, potentially offering a more wholesome nutrition profile. Researchers are excited about this treatment because it could provide a healthier, more natural alternative to existing commercial formulas, aligning more closely with the nutritional benefits of breastmilk while being readily available for parents seeking organic options.

What evidence suggests that this trial's formulas could be effective for healthy infant growth?

Research has shown that the new organic baby formula, which participants in this trial may receive, helps healthy babies grow normally. In earlier studies, babies who consumed this formula grew at the same rate as those using regular formulas. The formula is easy for babies to digest and does not cause more side effects than other formulas. It provides all the essential nutrients babies need for healthy growth and development, making it a good choice for parents seeking an organic option. ^{2 6 7 8 9}

Who Is on the Research Team?

Thomas Lynch, MD

Principal Investigator

SPRIM Pro

Are You a Good Fit for This Trial?

This trial is for healthy newborns, born at full term with a weight between 2,500 g and 4,500 g. They must be no older than 11 days when joining the study and can either be exclusively formula-fed or breastfed. Caregivers must agree to follow the study's protocol without introducing non-study formulas or solid foods.

Inclusion Criteria

You are a single person.

A competent and willing caregiver must sign the IRB approved informed consent document.

You have a caregiver who is willing to abide by the protocol demands (e.g

Exclusion Criteria

Caregiver intent to feed non-study formula or solid food during the study

Maternal, fetal, or infant medical history thought to have an impact on growth and/or development (substance abuse, positive HIV status, opioid exposure, or diabetes requiring insulin)

Your baby is currently taking prescribed medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the new organic infant formula or the commercially available organic infant formula for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Commercial Organic Infant Formula
• New Organic Infant Formula

Trial Overview The study tests whether Bobbie's new organic infant formula supports growth in babies similarly to an existing commercial formula. It includes a reference group of breastfed infants for comparison purposes.

How Is the Trial Designed?

Group I: New Organic Infant Formula Experimental Treatment 1 Intervention

New organic infant formula for healthy term infants

Group II: Commercial Organic Infant Formula Active Control 1 Intervention

Commercially available organic infant formula for healthy term infants

Group III: Breastfed Reference Group Active Control 1 Intervention

Breastmilk

Who Is Running the Clinical Trial?

Bobbie Baby, Inc

Lead Sponsor

Trials

1

Recruited

340+

Published Research Related to This Trial

Partially hydrolyzed formulas (pHFs) appear to be safe for healthy term infants in terms of growth, as limited data suggest they are not harmful when breastfeeding is not possible.

However, there is a significant lack of data on the long-term effects of pHFs, particularly regarding immune, metabolic, and hormonal outcomes, indicating a need for further research before recommending them universally for all infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should Partial Hydrolysates Be Used as Starter Infant Formula? A Working Group Consensus. Vandenplas, Y., Alarcon, P., Fleischer, D., et al.[2022]

In a study involving 402 formula-fed infants, lower protein hydrolyzed formulas (1.9 g protein/100 kcal) were found to support normal weight gain comparable to regular protein formulas (2.3 g protein/100 kcal) during the first 4 months of life, indicating their safety and efficacy.

The study confirmed that all tested low-protein hydrolyzed formulas provided balanced nutrition and allowed for adequate growth without compromising weight gain, making them a viable option for infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth: A Randomized Controlled Noninferiority Trial. Ahrens, B., Hellmuth, C., Haiden, N., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-healthy-growth-2-2023-aafd6

New Organic Infant Formula for Healthy Growth In trials, it supported normal growth and was well-tolerated, with no significant differences in adverse events compared to standard formulas. However, some ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04671576

Growth and Safety Clinical Trial on a New Infant Formula. The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula. Detailed Description. A 16-weeks ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11000068/

Gastrointestinal tolerability of organic infant formula compared ... Composition of organic infant formula‎. Organic infant formula is designed to provide infants with the essential nutrients for healthy growth and development.

4. mdpi.com mdpi.com/2072-6643/17/19/3111

Effects of Infant Formula Type on Early Childhood Growth ... Infants who consumed non-standard and standard formulas consistently showed significantly higher growth z-scores compared to breastfed infants across weight-for ...

5. abbott.com abbott.com/corpnewsroom/nutrition-health-and-wellness/with-infant-formula-innovating-means-getting-ever-closer-to-breast-milk.html

With infant formula, innovating means getting ever closer to ... Inspired by breast milk and driven by science, we keep innovating on our infant formula to better support babies.

6. consumerreports.org consumerreports.org/babies-kids/baby-formula/baby-formula-contaminants-test-results-a7140095293/

We Tested 41 Baby Formulas for Lead and Arsenic Consumer Reports recently tested 41 types of powdered formula for a number of toxic chemicals, including arsenic, lead, BPA, acrylamide, and PFAS.

7. fda.gov fda.gov/food/resources-you-food/infant-formula

Infant Formula The FDA does not approve infant formulas; however, infant formula manufacturers must notify the agency before marketing a new formula. The ...

8. cleanlabelproject.org cleanlabelproject.org/infant-formula-study/

Infant Formula Study Key Data and Findings · 31.6% of Legacy Products (or 6 out of the 19 products) tested positive for DBP or di-n-butyl phthalate · 21.1% of Legacy Products (or 4 ...

9. thebump.com thebump.com/news/baby-formula-contaminants-study

New Report Tests Baby Formulas for Harmful Contaminants A new Consumer Reports study has identified potentially concerning levels of lead, arsenic and other contaminants in several popular infant formulas.