Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT06262867
Eligibility Criteria:
Inclusion Criteria:
* Full term, singleton birth
* Infant will be 2-5 months old at the time of study enrollment
* Able to participate in the study under the supervision of a caregiver or legal guardian -who must be:
1. At least 18 years of age
2. The caregiver or legal guardian of the infant
3. Living with the infant for the duration of the study
4. Willing to follow all caregiver responsibilities
5. Willing and able to sign the electronic Informed Consent
6. Willing to conform to all protocol requirements (e.g., completion of study questionnaires and procedures, and reporting of AEs)
* Caregiver or legal guardian who owns a functioning smartphone device, has access to an internet connection (Wi-Fi or data plan), and is willing to download the study app
Exclusion Criteria:
* Known sensitivity/allergy to egg, cow's milk, or peanut (including products containing egg, cow's milk, or peanut) or undergoing evaluation for reactions due to cow's milk, egg, or peanut exposure (including exposure to products containing egg, cow's milk, or peanut).
* Participating in a clinical trial and/or treated with any investigational product within 3 months preceding the first dose of study product.
* Clinically significant medical conditions such as cardiac disease or lung disease, and/or babies who have bloody stools that have required milk elimination that are unstable or uncontrolled and may interfere with a participant's participation in the study in the opinion of the medically qualified investigator.
* Other severe, acute or chronic, medical or psychiatric condition(s) or laboratory abnormality(ies) that may increase the risk associated with study participation or intervention product administration or may interfere with the interpretation of study results, and in the judgment of the medically qualified investigator, would make the participant inappropriate for entry into this study.
* Preterm delivery (\<37 weeks \[259 days\] gestational age).
* Admission to the neonatal unit ≥ 3 days for issues other than establishment of normal feeding.
* Chronic use of antibiotics (≥ 28 consecutive days)
* Evidence of a baseline illness that would, in the opinion of the PI, introduce a significant safety concern if the infant is enrolled in the study or otherwise preclude study participation.
* Significant birth defect/complication that would, in the opinion of the PI, create a safety concern or otherwise confound the study (e.g., abdominal wall defects, congenital heart disease).
* Medical condition (infant) that, in the opinion of the PI, may significantly alter gut microbiota or healthy immune responses.
* Maternal infection with human immunodeficiency virus, tuberculosis, hepatitis C, or hepatitis B.
* Caregiver condition that, in the opinion of the PI, would not allow the Caregiver and/or infant to comply with the study protocol requirements.
* History of immunocompromised conditions. Is related to persons involved directly or indirectly with the conduct of this study (i.e., PI, sub-investigators, study coordinators, other study personnel, employees of Ready. Set. Food! contractors of Ready. Set. Food! and the families of each).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
5 Months
Study:
NCT06262867
Study Brief:
Protocol Section:
NCT06262867