Tolerance of a Probiotic Formula

Probi AB

Status: Completed

Conditions: Safety Issues

Treatments: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03925558

ProTolerance

Details and patient eligibility

About

Evaluate the tolerance of a probiotic formula in infants

Enrollment: 36 patients

Sex: All

Ages: 3 to 95 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Probiotic formula

Active Comparator group

Description:

Lactobacillus strains

Treatment:

Dietary Supplement: Probiotics

Placebo formula

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo