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Probiotic Supplementation in Breastfed Newborn Infants

NCT02286999 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-11-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

B. infantis

Infants in the intervention group will receive two doses of B. infantis on Day 7 and Day 14 of life, while infants in the placebo group will be dosed with placebo on Day 7 and Day 14

DRUG

Placebo

Sponsors & Collaborators

  • Emanual Maverakis, MD

    lead OTHER

Principal Investigators

  • Emanual Maverakis, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-01-31
Completion
2018-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02286999 on ClinicalTrials.gov