Tolerance of a Probiotic Formula

Safety Issues Clinical Trial

Official title:

Tolerance of a Probiotic Formula Containing Lactobacilli

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925558
• Other study ID #: ProTolerance
• Status: Completed
• Phase: N/A
• Start date: April 12, 2011
• Est. completion date: December 19, 2011

Study information

• Verified date: April 2019
• Source: Probi AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the tolerance of a probiotic formula in infants

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 19, 2011
• Est. primary completion date: December 19, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 95 Days

Eligibility

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

Related Conditions & MeSH terms

• Safety Issues

Intervention

Dietary Supplement:
• Probiotics

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Probi AB

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight (g)		8 weeks
Primary	Body length (cm)		8 weeks
Primary	Head circumference (cm)		8 weeks