Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A - 14 Days|
- - Healthy term infant.
- - Has at least one first degree relative (that is biological parent or full sibling) with a history of atopic disease (that is mother-reported, physician-diagnosed Atopic Dermatitis (AD), allergic rhinitis, or asthma) - Breastfeeding established (as determined by the principal Investigator [PI] or designee) at the time of study enrollment (Day 0), with maternal intent to maintain exclusive breastfeeding for greater than or equal to (>=)12 weeks.
- - Will participate in the study under supervision of his/her biological mother ("Caregiver") who is: a) At least 18 years old b) The legal guardian of the infant c) Intending to cohabitate with the infant for the duration of the study d) Willing to follow all Caregiver responsibilities e) Fluent in Finnish, Swedish, or English.
- - The PI considers the Caregiver likely to adequately comply with the study protocol
requirements based on demonstrated compliance with antenatal appointments and
agreement to complete the intuitive, interactive, electronic diary (eDiary) utilizing
personal smart device (example, tablet, cell phone)
Exclusion Criteria:- Preterm delivery (< 36 weeks [252 days] gestational age) - Admission to the neonatal unit for issues other than establishment of normal feeding.
- - Evidence of a baseline illness/condition (example abnormal birth weight) or significant risk of developing an illness/condition (based on review of maternal/pregnancy information) that would, in the opinion of the Principal Investigator (PI) or designee, introduce a significant safety concern if the infant were enrolled in the study or otherwise preclude study participation.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Johnson & Johnson Consumer Inc. (J&JCI)|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Samuli Rautava, M.D., Ph.D.|
|Principal Investigator Affiliation||Helsinki University Central Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: B. infantis
A once-daily feeding of activated B. infantis EVC001 (8.0 *10^9 colony forming units [CFU]) will be provided to infants for 12 weeks.
Placebo Comparator: Placebo
A once-daily oral feeding of lactose placebo will be provided to infants for 12 weeks.
Other: - B. infantis
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU), will be provided to infants once daily for 12 weeks.
Other: - Lactose Placebo
Powdered infant formula grade lactose will be provided to infants once daily for 12 weeks.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.