New Organic Infant Formula for Healthy Growth

ObvioHealth, New York, NY
Healthy GrowthNew Organic Infant Formula - Other
Eligibility
No minimum age - 11
All Sexes
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Study Summary

This trial aims to show that a new formula for babies grows them as well as existing cow's milk formula, and compares to breastfeeding too.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Study Day 98 to Study Day 112

Day 112
Anthropometry Z-scores
Caregiver report of crying obtained during 3-consecutive day intervals
Caregiver report of fussiness obtained during 3-consecutive day intervals
Caregiver report of gassiness obtained during 3-consecutive day intervals
Caregiver report of spit up obtained during 3-consecutive day intervals
Caregiver report of stool consistency obtained during 3-consecutive day intervals
Caregiver report of stool frequency obtained during 3-consecutive day intervals
Caregiver report of vomiting obtained during 3-consecutive day intervals
Formula Intake
Formula Intake (2)
Head Circumference
Length
Weight Gain Velocity
Day 119
Adverse Event (AE) Assessment
Study Day 112
Formula Satisfaction
Day 112
Urinalysis

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Breastfed Reference Group
1 of 3
Commercial Organic Infant Formula
1 of 3
New Organic Infant Formula
1 of 3

Active Control

Experimental Treatment

335 Total Participants · 3 Treatment Groups

Primary Treatment: New Organic Infant Formula · No Placebo Group · N/A

New Organic Infant Formula
Other
Experimental Group · 1 Intervention: New Organic Infant Formula · Intervention Types: Other
Breastfed Reference GroupNoIntervention Group · 1 Intervention: Breastfed Reference Group · Intervention Types:
Commercial Organic Infant Formula
Other
ActiveComparator Group · 1 Intervention: Commercial Organic Infant Formula · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: study day 98 to study day 112

Who is running the clinical trial?

Bobbie Baby, IncLead Sponsor
Parth Shah, MD, FAPCRPrincipal InvestigatorObvioHealth

Eligibility Criteria

Age No minimum age - 11 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a single person.

Frequently Asked Questions

Who is eligible to be part of this scientific research?

"The trial, which has a total capacity of 335 participants, is seeking infants between 0 Days and 11 Days old who present no health issues." - Anonymous Online Contributor

Unverified Answer

Does this trial encompass people of all ages, or is the age limit set at 50?

"This medical study is enrolling minors who are younger than 11 Days of age and have surpassed their 0 Day birthday." - Anonymous Online Contributor

Unverified Answer

Is this experiment currently open to participants?

"According to information on clinicaltrials.gov, this particular clinical trial is not presently recruiting patients. The initial post was made March 1st 2023 and the last edit occurred 23rd of March in the same year. Nevertheless, there are still one other trials currently enrolling volunteers at this moment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.