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Completed

NCT Number: NCT00760851

Yogurt Study in Children 2-4 Years Old Attending Daycare

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

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Key information

Conditions

Infections, Respiratory Diarrhea Infections Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Georgetown University Department of Family Medicine, Research Division

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

probiotic strain Bb-12

Other

10^9 CFU Bb-12 per 4 oz yogurt

Other names: Bifidobacterium lactis 12

no Bb-12

Other

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

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

    Time frame: 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

    Time frame: 90

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • Penn State University
  • United States Department of Agriculture (USDA)

Registry information

Official study title

Study to Investigate the Potential of Probiotics II

Acronym: SIPPY II

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Sep 26, 2008
Registry last updated
Mar 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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