NCT02286999

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 infants. The study will also examine whether supplementation with this probiotic can reduce the chance of developing eczema and food allergies in enrolled infants.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

2.3 years

First QC Date

October 23, 2014

Last Update Submit

November 13, 2019

Conditions

Atopic DermatitisFood Allergies

Outcome Measures

Primary Outcomes (2)

  • Pharmacologically effective dose (ED) of B. infantis

    The primary endpoint of the study is identification of a pharmacologically effective dose of B. infantis required to produce predominant (\>50%) gut colonization at six weeks of age

    Two years

  • Safety of Probiotic Supplementation, as assessed by frequency of adverse events

    An additional primary endpoint is to determine the safety of B. infantis supplementation in immunocompetent, full-term infants. Any adverse events including fever 102°F or higher, abdominal pain or colic, blood or pus in the stool, diarrhea or vomiting will be documented and dosing adjusted accordingly

    2 years

Secondary Outcomes (2)

  • Milk Oligosaccharide Consumption

    2 years

  • Stool Microbiota Composition

    2 years

Study Arms (2)

B.infantis

EXPERIMENTAL

Infants in the experimental arm will have two doses of the probiotic Bifidobacterium longum subsp. infantis (B. infantis) on Day 7 and Day 14 of life.

Drug: B. infantis

Placebo

PLACEBO COMPARATOR

Infants in the experimental arm will have two doses of placebo (powdered maltodextrin) on Day 7 and Day 14 of life.

Drug: Placebo

Interventions

B. infantisDRUG

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

Also known as: Probiotic
B.infantis
PlaceboDRUG
Placebo

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Publications (1)

  • Awasthi S, Wilken R, Patel F, German JB, Mills DA, Lebrilla CB, Kim K, Freeman SL, Smilowitz JT, Armstrong AW, Maverakis E. Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants: study protocol for a randomised controlled trial. Trials. 2016 Jul 22;17(1):340. doi: 10.1186/s13063-016-1467-1.

    PMID: 27449926DERIVED

MeSH Terms

Conditions

Dermatitis, AtopicFood Hypersensitivity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Emanual Maverakis, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2014

First Posted

November 10, 2014

Study Start

October 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

November 15, 2019

Record last verified: 2019-11

Locations

US(1)