Probiotic Supplementation in Breastfed Newborn Infants

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Atopic Dermatitis, Food Allergies

In brief

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.

Key facts

Study ID

NCT02286999

Run by

Emanual Maverakis, MD

People needed

0

Starts

2015-10-01

Expected to finish

2018-01-01

Last updated by the study team

2019-11-15

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy newborn infants between 1 and 7 days old with intent to be exclusively breastfed for a minimum of six (6) months

You may not qualify if…

• 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.

Where it is running

• University of California, Davis Department of Dermatology — Sacramento, California, United States

Full record on ClinicalTrials.gov

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