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Clinical Trial Details for Probiotic Supplementation in Breastfed Newborn Infants


Emanual Maverakis, MD
NCT ID: NCT02286999
Last Updated: October 26, 2017

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 1
  • Gender: All
  • Age: N/A - 7 Days
  • Condition:
    • Atopic Dermatitis
    • Food Allergies
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Emanual Maverakis, MD
  • Location: Not Provided

Official Title

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

Purpose

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.

Eligibility

Ages Eligible for Study

N/A to 7 Days

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Accepts Healthy Volunteers

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.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Emanual Maverakis, MD

Investigators

Principal Investigator: Emanual Maverakis, MD

University of California, Davis

Please refer to this study by its ClinicalTrials.gov identifier: NCT02286999

Location

Contacts

University of California, Davis Department of Dermatology

Sacramento, California 95816

United States

Emanual Maverakis, M.D.

emaverakis@ucdavis.edu