NCT00760851

Brief Summary

The purpose of this study is to determine the effectiveness of probiotics (popularly referred to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent absences from school/daycare centers of children two to four years old that attend daycare at least 3 days per week. Two yogurt drinks will be administered, one containing a specific strain of probiotic, Bb-12. It is hypothesized that children receiving the Bb-12 drink will experience fewer illnesses and absences from daycare. In this study, participants will be asked to:

  1. 1.Give their child 4 oz. of the test yogurt each day for 90 days
  2. 2.Keep a daily diary of their child's health
  3. 3.Collect 3 stool samples from their child at the start, middle, and end of the study
  4. 4.Speak with research personnel on a bi-weekly basis regarding their child's health
  5. 5.Ensure that their child to consume any yogurts or probiotic-containing products for 110 days of the study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2008

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

September 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

March 18, 2011

Status Verified

February 1, 2011

Enrollment Period

10 months

First QC Date

September 24, 2008

Last Update Submit

March 17, 2011

Conditions

Infections, RespiratoryDiarrhea

Keywords

ProbioticsChild, preschoolChild Day Care CentersHealthImmune system

Outcome Measures

Primary Outcomes (1)

  • To determine if consumption of a yogurt drink containing Bb-12 decreases the number of absences children have from daycare/school due to illness

    90 days

Secondary Outcomes (1)

  • Determine if the yogurt supplemented with Bb-12 results in overall improved parental satisfaction due to decreased illnesses in children attending daycare/school

    90

Study Arms (2)

1

EXPERIMENTAL

Bb-12 supplemented strawberry yogurt drink

Other: probiotic strain Bb-12

2

PLACEBO COMPARATOR

Regular strawberry yogurt drink with no Bb-12 added

Other: no Bb-12

Interventions

probiotic strain Bb-12OTHER

10\^9 CFU Bb-12 per 4 oz yogurt

Also known as: Bifidobacterium lactis 12
1
no Bb-12OTHER

yogurt identical to intervention yogurt, only without Bb-12 added.

2

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child aged 2 to 4 years of age
  • Child attends daycare at least 3 days per week

You may not qualify if:

  • Caregiver does not speak English or Spanish
  • Caregiver does not agree to have their child refrain from cultured dairy products (yogurt) for the 105-day duration of the study
  • Caregiver does not agree to collect a stool sample from their child on Day 0, 45, and 105 of the study
  • Caregiver does not have a refrigerator to store the yogurt product at home
  • Child is currently receiving breast milk
  • Child has an allergy or hypersensitivity to milk proteins or other dairy food components such as lactose
  • Child has an allergy or hypersensitivity to strawberry or red food coloring
  • Child has a chronic disease
  • Child has had an infection or been sick 7 days prior to starting study
  • Child has had diarrhea or constipation 7 days prior to starting study
  • Child has a special diet as prescribed by a medical professional
  • Child has received antibiotics, antiseptics, antifungal, corticosteroids, anti-histamines, non steroidal anti-inflammatory drugs within 7 days prior to starting the study
  • Child has a congenital anomaly or birth defect that requires medical care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Department of Family Medicine, Research Division

Washington D.C., District of Columbia, 20009, United States

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsDiarrhea

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Merenstein, MD

    Georgetown University

    PRINCIPAL INVESTIGATOR

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

September 24, 2008

First Posted

September 26, 2008

Study Start

September 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2010

Last Updated

March 18, 2011

Record last verified: 2011-02

Locations

US(1)