Tolerance of a Probiotic Formula

Tolerance of a Probiotic Formula Containing Lactobacilli

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03925558

Enrollment

Registered

2019-04-24

Start date

2011-04-12

Completion date

2011-12-19

Last updated

2019-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety Issues

Brief summary

Evaluate the tolerance of a probiotic formula in infants

Interventions

DIETARY_SUPPLEMENTProbiotics

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Days to 95 Days

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

Design outcomes

Primary

Measure	Time frame
Body weight (g)	8 weeks
Body length (cm)	8 weeks
Head circumference (cm)	8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026