NCT00492583

Brief Summary

The purpose of this study is to determine if the consumption of a yogurt drink containing a high dose of probiotics decreases absences, due to illnesses, in daycare centers for children between the ages of 1 and 3.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P50-P75 for phase_3 healthy

Timeline
Completed

Started Jul 2007

Typical duration for phase_3 healthy

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

First Submitted

Initial submission to the registry

June 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
3 years until next milestone

Results Posted

Study results publicly available

August 17, 2011

Completed
Last Updated

August 17, 2011

Status Verified

June 1, 2011

Enrollment Period

1.1 years

First QC Date

June 25, 2007

Results QC Date

June 21, 2011

Last Update Submit

July 21, 2011

Conditions

Healthy

Keywords

probiotichealthbifidobacterium lactisBB-12

Outcome Measures

Primary Outcomes (1)

  • Number of Days Children Are Out of School Sick

    Outcome measure, "number of days children are out of school sick" was measured for the entire population

    90 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects were provided 4 fluid ounces (112 grams) administered orally per day of placebo drink.

Drug: Placebo

Bifidobacterium lactis (BB-12)

EXPERIMENTAL

Subjects were provided 4 fluid ounces (112 grams) administered orally per day of active drink.

Drug: Bifidobacterium lactis (BB-12)

Interventions

Bifidobacterium lactis (BB-12)DRUG

The active drink is currently available commercially on campus at The Berkey Creamery at Penn State in State College, Pennsylvania. The active drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus. The active drink was also supplemented with the probiotic BB-12, acquired from Chr. Hansen (Milwaukee, Wisconsin).

Bifidobacterium lactis (BB-12)
PlaceboDRUG

The placebo drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus.

Placebo

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • aged 1-3
  • attending daycare or preschool centers at least 3 days a week
  • male or female
  • parents must speak English or Spanish
  • subjects or parents/legal guardians who agree to have their child refrain from consuming any other yogurts or foods containing probiotics for the duration of the study

You may not qualify if:

  • subjects with developmental delays
  • subjects with chronic conditions such as diabetes or asthma that require daily medication
  • subjects with birth weight \<2500 grams
  • subjects with strawberry allergies
  • subjects with active diarrhea
  • subjects with congenital anomalies
  • subjects with failure to thrive
  • subjects with parental belief of lactose intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Department of Family Medicine

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (1)

  • Merenstein DJ, Smith KH, Scriven M, Roberts RF, Sanders ME, Petterson S. The study to investigate the potential benefits of probiotics in yogurt, a patient-oriented, double-blind, cluster-randomised, placebo-controlled, clinical trial. Eur J Clin Nutr. 2010 Jul;64(7):685-91. doi: 10.1038/ejcn.2010.30. Epub 2010 Mar 10.

    PMID: 20216564RESULT

Results Point of Contact

Title
Daniel J Merenstein, MD
Organization
Georgetown University
djm23@georgetown.edu
202-687-2745

Study Officials

  • Daniel J Merenstein, MD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 27, 2007

Study Start

July 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 17, 2011

Results First Posted

August 17, 2011

Record last verified: 2011-06

Locations

US(1)