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A Parallel-group, Randomized, Placebo-controlled Ascending Dose Phase I Study Protocol for Dietary Supplementation With Bifidobacterium Longum Subsp. Infantis (B. Infantis) in Healthy Breastfed Infants
The purpose of this study is to investigate the dose of a probiotic supplement (Bifidobacterium longum subsp. infantis) required to achieve predominant gut colonization in healthy newborn, breastfed infants. The study will also examine whether supplementation with this probiotic can reduce the chance of developing eczema and food allergies in enrolled infants.
N/A to 7 Days
Accepts Healthy Volunteers
– Healthy newborn infants between 1 and 7 days old with intent to be exclusively
breastfed for a minimum of six (6) months
– Infants given dietary supplementation, including other probiotics.
– Infants born prior to 34 weeks gestation.
– Infants below 10th percentile for body weight.
– Postnatal use of antibiotics (oral, intramuscular or intravenous) by either the mother
or the infant. Of note, prenatal maternal Group B streptococcus prophylaxis is not a
criterion for study exclusion.
– Family history of immunodeficiency syndrome(s).
– Infants with signs of a clinically apparent underlying immunodeficiency.
– Intent to use non-breast milk infant formula for feeding during the first six months.
– History of GI tract abnormality or infection.
Emanual Maverakis, MD
Principal Investigator: Emanual Maverakis, MD
University of California, Davis
Please refer to this study by its ClinicalTrials.gov identifier: NCT02286999
University of California, Davis Department of Dermatology
Sacramento, California 95816
Emanual Maverakis, M.D.email@example.com