Status:
WITHDRAWN
Probiotic Supplementation in Breastfed Newborn Infants
Lead Sponsor:
Emanual Maverakis, MD
Conditions:
Atopic Dermatitis
Food Allergies
Eligibility:
All Genders
1-7 years
Phase:
PHASE1
Brief 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 i...
Detailed Description
The proposed phase I clinical trial is a parallel-group, placebo-controlled, randomized, double-blind ascending dose study of dietary supplementation with Bifidobacterium longum subsp. infantis (B. in...
Eligibility Criteria
Inclusion
- Healthy newborn infants between 1 and 7 days old with intent to be exclusively breastfed for a minimum of six (6) months
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02286999
Start Date
October 1 2015
End Date
January 1 2018
Last Update
November 15 2019
Active Locations (1)
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1
University of California, Davis Department of Dermatology
Sacramento, California, United States, 95816