Your session is about to expire
← Back to Search
Organic Cow's Milk-Based Formula
New Organic Infant Formula for Healthy Growth
N/A
Recruiting
Led By Thomas Lynch, MD
Research Sponsored by Bobbie Baby, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 98 to study day 112
Awards & highlights
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.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As this trial involves healthy infants and standard feeding practices (breastfeeding or commercial formulas), significant side effects are not anticipated; however, any potential adverse reactions will be closely monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study day 98 to study day 112
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 98 to study day 112
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight Gain Velocity
Secondary outcome measures
Anthropometry Z-scores
Formula Intake
Formula Intake (2)
+2 moreOther outcome measures
Adverse Event (AE) Assessment
Caregiver report of crying obtained during 3-consecutive day intervals
Caregiver report of fussiness obtained during 3-consecutive day intervals
+7 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: New Organic Infant FormulaExperimental Treatment1 Intervention
New organic infant formula for healthy term infants
Group II: Commercial Organic Infant FormulaActive Control1 Intervention
Commercially available organic infant formula for healthy term infants
Group III: Breastfed Reference GroupActive Control1 Intervention
Breastmilk
Find a Location
Who is running the clinical trial?
Bobbie Baby, IncLead Sponsor
Thomas Lynch, MDPrincipal InvestigatorSPRIM Pro
1 Previous Clinical Trials
903 Total Patients Enrolled
Parth Shah, MD, FAPCRPrincipal InvestigatorObvioHealth
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.gYou are an infant aged 11 days or younger at the time of enrollment.Your baby is currently taking prescribed medication.You or a family member (parent or sibling) are allergic to cow's milk protein, except for lactose intolerance.Your baby has taken medications that can affect their growth, digestion, or development.You have experienced a healthy gestation period of between 37 and 41 weeks, 6 days.Your birth weight was between 2,500 grams and 4,500 grams.You are a caregiver who has made the choice to solely feed your infant formula or breast milk and is eager to maintain this feeding method during the research.The baby has health problems since birth, such as issues with the brain or body movement.You or a family member (grandparent, parent, sibling) has a known disorder related to how the body processes folate.The baby is not growing or gaining weight properly, has a fever, or has any problems related to their digestive system, such as acid reflux or a shortened gut. They also have any birth defects or health conditions that may affect their feeding or growth.
Research Study Groups:
This trial has the following groups:- Group 1: New Organic Infant Formula
- Group 2: Commercial Organic Infant Formula
- Group 3: Breastfed Reference Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger