Phase 3
Completed N=182
Study to Investigate the Potential of Probiotics in Yogurt
Healthy
Source: ClinicalTrials.gov NCT00492583 ↗
Enrolled (actual)
182
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Number of Days Children Are Out of School Sick — 2.51; 2.82 days per 100 person days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days Children Are Out of School Sick |
2.51; 2.82 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00492583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.