Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
45 participants
INTERVENTIONAL
2021-07-13
2022-11-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study Infant Formula
Feed ad libitum during study period
Study Infant Formula
RTF milk-based infant formula with oligosaccharides
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Study Infant Formula
RTF milk-based infant formula with oligosaccharides
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
* Participant's birth weight was \>= 2490 g (\~5 lbs. 8 oz.)
* Participant was identified by parents as very fussy or extremely fussy in the Baseline Tolerance Evaluation on a formula-feed
* Participant is exclusively formula-fed at time of study entry and Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
* Parent(s) confirm their intention not to administer vitamin, mineral, human milk oligosaccharide(s) (HMO), prebiotic(s), or probiotic(s) supplements (with the exception of vitamin D supplements if instructed by their healthcare professional), non-study formula, foods, juices, or other sources of nutrition to their infant from enrollment through the duration of the study
* Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided applicable local privacy regulation authorization prior to any participation in the study
Exclusion Criteria
* Participant is taking and plans to continue taking medications (including OTC, such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance.
* Participant participates in another study that has not been approved as a concomitant study
* Participant has been fed a formula with greater than 2 HMOs prior to study enrollment
* Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to study enrollment and/or an extensively hydrolyzed, amino acid based, or preterm formula has been recommended by the physician.
* Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
* Participant has been treated with antibiotics within 7 days prior to enrollment
7 Days
65 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Nutrition
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elizabeth Reverri, PhD, MS, RD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MedPharmics, LLC
Phoenix, Arizona, United States
Dade Research Center, LLC
Miami, Florida, United States
Meridian Clincial Research- Macan
Macon, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Springs Medical Research
Owensboro, Kentucky, United States
MedPharmics
Covington, Louisiana, United States
Boeson Research Kalispell
Kalispell, Montana, United States
Meridian Clinical Research
Hastings, Nebraska, United States
Be Well Clinical Studies
Lincoln, Nebraska, United States
AVIATI Healthcare & Clinical Research
Memphis, Tennessee, United States
Invesclinic US LLC
Edinburg, Texas, United States
Maximos Ob/Gyn
League City, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AL41
Identifier Type: -
Identifier Source: org_study_id