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.
TERMINATED
NA
65 participants
INTERVENTIONAL
2009-12-31
2013-03-31
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.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Infant formula with probiotic
Infant formula with probiotic for 0 to 12 months of age
Milk based infant formula with probiotic
formula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration
Standard infant formula
Infant formula for 0 to 12 months of age
Milk based infant formula
supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Milk based infant formula with probiotic
formula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration
Milk based infant formula
supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 3 weeks to less than or equal to 4 months of age upon enrollment
* experiencing ongoing crying and fussy episodes of a minimum of 3 hours of crying /day for 3 days in a week for at least one week prior to enrollment
* otherwise healthy as reported by parent/caregiver
* is under the care of a pediatrician or other qualified healthcare professional and has had at least one postnatal visit
* taking no more than one feeding of breast milk per day
* having not initiated weaning foods or beverages other than infant formula or breast milk
* study explained and written information provided with Parent/caregiver demonstrating understanding of the given information
* informed consent signed(parent/legal representative)
Exclusion Criteria
* known cow's milk allergy
* receiving any type of therapeutic formula (including extensively hydrolyzed formula or free amino acid formula)
* receiving an antibiotic or probiotic in the week prior to enrollment
* complicated reflux, defined by reflux combined with inadequate growth and/or respiratory complications
* infant's family, who in the investigator's assessment, cannot be expected to comply with the protocol
* infant currently participating in another conflicting clinical study
3 Weeks
4 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Société des Produits Nestlé (SPN)
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.
Michael D Cabana, MD,MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco, USA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Investigational Research Program, LLC
Bentonville, Arkansas, United States
University of California, San Francisco
San Francisco, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Florida Institute for Clinical Research
Orlando, Florida, United States
Pedia Research, LLC
Newburgh, Indiana, United States
Pedia Research
Owensboro, Kentucky, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Southwest Children's Research Associates, P.A.
San Antonio, 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.
09.03.INF
Identifier Type: -
Identifier Source: org_study_id