New Organic Infant Formula for Healthy Growth

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

335 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.

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.

What data supports the effectiveness of the treatment New Organic Infant Formula for healthy growth?

Research on similar nutrient-enriched formulas shows they can help preterm infants grow better and develop more effectively after leaving the hospital. Additionally, a study on a new infant formula found it compared well to other formulas and breast-fed infants in terms of growth and health. ^{1 2 3 4 5}

Is the new organic infant formula safe for infants?

The new organic infant formula has been tested in various studies and is generally considered safe for infants. In trials, it supported normal growth and was well-tolerated, with no significant differences in adverse events compared to standard formulas. However, some studies suggest that formula-fed infants may experience more gastrointestinal symptoms than breastfed infants. ^{6 7 8 9 10}

How does the New Organic Infant Formula treatment differ from other infant formulas?

The New Organic Infant Formula is unique because it may include genetically engineered components that enhance immunity and nutrient absorption, potentially offering better protection against infections and supporting growth in infants who may not thrive on standard formulas or human milk. ^{7 10 11 12 13}

Research Team

Thomas Lynch, MD

Principal Investigator

SPRIM Pro

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Nutrient-enriched formula versus standard term formula for preterm infants following hospital discharge. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Nutrient-enriched formula versus standard term formula for preterm infants following hospital discharge. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Nutrient-enriched formula versus standard formula for preterm infants following hospital discharge. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Calorie and protein-enriched formula versus standard term formula for improving growth and development in preterm or low birth weight infants following hospital discharge. [2018]

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

Growth and tolerance studies of a new infant formula. [2017]

6. Denmark pubmed.ncbi.nlm.nih.gov

[Testing of a liquid, ready-to-use, breast milk substitute in the county of Funen]. [2008]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a Novel Infant Formula on Weight Gain, Body Composition, Safety and Tolerability to Infants: The INNOVA 2020 Study. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

An Infant Formula with Partially Hydrolyzed Whey Protein Supports Adequate Growth and Is Safe and Well-Tolerated in Healthy, Term Infants: A Randomized, Double-Blind, Equivalence Trial. [2021]

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

Should Partial Hydrolysates Be Used as Starter Infant Formula? A Working Group Consensus. [2022]

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

Infant formula, past and future: opportunities for improvement. [2018]

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

Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth: A Randomized Controlled Noninferiority Trial. [2019]

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

Effects of infant formula supplemented with prebiotics compared with synbiotics on growth up to the age of 12 mo: a randomized controlled trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Growth of infants fed formula supplemented with Bifidobacterium lactis Bb12 or Lactobacillus GG: a systematic review of randomized controlled trials. [2021]