NCT00113659

Brief Summary

The goal of the study is to understand the mechanisms of how antigen presentation affects the developing immune system and subsequently affects susceptibility to, or protects against, asthma development. This randomized controlled study will test the effectiveness of daily supplementation of Lactobacillus GG for the first 6 months of life on the early immunological development of asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2005

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

8.9 years

First QC Date

June 9, 2005

Last Update Submit

June 10, 2024

Conditions

Asthma

Keywords

AsthmaProbioticsPreventionEczema

Outcome Measures

Primary Outcomes (1)

  • Development of atopic dermatitis

    Measured from birth to 3 years of age

Secondary Outcomes (1)

  • Early clinical markers of asthma, including frequent wheezing, wheezing without upper or lower respiratory tract infections, allergic rhinitis, atopic dermatitis, serum IgE, and eosinophilia

    Measured from birth to 3 years of age

Study Arms (2)

1

ACTIVE COMPARATOR

Participants in this arm will receive Lactobacillus GG.

Dietary Supplement: Probiotic

2

PLACEBO COMPARATOR

Participants in this arm will receive a placebo.

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

Daily dose of ten to the tenth colony-forming units of Lactobacillus GG and 225 mg of inulin for the first 6 months of life.

Also known as: Culturelle
1
PlaceboDIETARY_SUPPLEMENT

Daily dose of placebo supplement containing 325mg inulin for the first 6 month of life.

2

Eligibility Criteria

Age1 Day - 4 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Expectant parents either of whom have a history of asthma
  • Parents willing to add a probiotic supplement or placebo to one feeding each day for 6 months

You may not qualify if:

  • A sibling currently or previously enrolled in the study
  • Any major congenital birth deformities, acute illness at enrollment, or chronic conditions affecting food intake or metabolism
  • Participation in another clinical study
  • Infants from multiple gestation births (since only one child per family will be included in the study, incorporating a child from a multiple birth would add unnecessary burden to parents by requiring them to administer different formulas to different children)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

Related Publications (4)

  • Cabana MD, Shane AL, Chao C, Oliva-Hemker M. Probiotics in primary care pediatrics. Clin Pediatr (Phila). 2006 Jun;45(5):405-10. doi: 10.1177/0009922806289614.

    PMID: 16891272BACKGROUND

  • Cabana MD, McKean M, Wong AR, Chao C, Caughey AB. Examining the hygiene hypothesis: the Trial of Infant Probiotic Supplementation. Paediatr Perinat Epidemiol. 2007 Nov;21 Suppl 3:23-8. doi: 10.1111/j.1365-3016.2007.00881.x.

    PMID: 17935572BACKGROUND

  • Cabana MD, LeCroy MN, Menard-Livingston A, Rodgers CRR, McKean M, Caughey AB, Fong L, Lynch S, Wong A, Leong R, Boushey HA, Hilton JF. Effect of Early Infant Probiotic Supplementation on Eczema, Asthma, and Rhinitis at 7 Years of Age. Pediatrics. 2022 May 1;149(5):e2021052483. doi: 10.1542/peds.2021-052483. No abstract available.

    PMID: 35419605DERIVED

  • Cabana MD, McKean M, Beck AL, Flaherman V. Pilot Analysis of Early Lactobacillus rhamnosus GG for Infant Colic Prevention. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):17-19. doi: 10.1097/MPG.0000000000002113.

    PMID: 30052571DERIVED

MeSH Terms

Conditions

AsthmaEczema

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Michael D. Cabana, MD, MPH

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2005

First Posted

June 10, 2005

Study Start

June 1, 2005

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations

US(1)