Yogurt Study in Children 2-4 Years Old Attending Daycare (SIPPY II)

Georgetown University

Status and phase: Completed; Phase 3

Conditions: Diarrhea; Infections, Respiratory

Treatments: Other: probiotic strain Bb-12; Other: no Bb-12

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00760851

2008-01852

Details and patient eligibility

About

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

Enrollment: 190 estimated patients

Sex: All

Ages: 2 to 4 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Bb-12 supplemented strawberry yogurt drink

Treatment:

Other: probiotic strain Bb-12

2

Placebo Comparator group

Description:

Regular strawberry yogurt drink with no Bb-12 added

Treatment:

Other: no Bb-12