NCT03925558CompletedNot Applicable
Tolerance of a Probiotic Formula Containing Lactobacilli
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Probi AB
- Enrollment
- 36
- Primary Endpoint
- Head circumference (cm)
Study Overview
Brief Summary
Evaluate the tolerance of a probiotic formula in infants
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Days to 95 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Full term healthy infant aged 3-95 days
Exclusion Criteria
- •Prematurity
- •Low birth weight
- •Congenital anomalies
- •Chronic disease
- •Failure to thrive
- •Allergy or atopic disease
- •Recent exposure to antibiotics
Arms & Interventions
Probiotic formula
Active Comparator
Lactobacillus strains
Intervention: Probiotics (Dietary Supplement)
Placebo formula
Placebo Comparator
Placebo
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Head circumference (cm)
Time Frame: 8 weeks
Body weight (g)
Time Frame: 8 weeks
Body length (cm)
Time Frame: 8 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
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