Probiotic Supplementation in Breastfed Newborn Infants

• Status: Withdrawn
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emanual Maverakis, MD; University of California, Davis

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.