Tolerance of a Probiotic Formula

Not Applicable

Completed

• Conditions: Safety Issues
• Interventions: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

• Registration Number: NCT03925558
• Lead Sponsor: Probi AB

Brief Summary

Evaluate the tolerance of a probiotic formula in infants

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-12
• Primary Completion: 2011-12-19
• Study Completion: 2011-12-19
• Status Verified: 2019-04
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-23
• Last Update Submitted: 2019-04-23
• Study First Posted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic formula	Probiotics	Lactobacillus strains
Placebo formula	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Head circumference (cm)	8 weeks
Body length (cm)	8 weeks
Body weight (g)	8 weeks