Tolerance of a Probiotic Formula

NCT ID: NCT03925558

Last Updated: 2019-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-12

Study Completion Date

2011-12-19

Brief Summary

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Evaluate the tolerance of a probiotic formula in infants

Detailed Description

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Conditions

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Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic formula

Lactobacillus strains

Group Type ACTIVE_COMPARATOR

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Placebo formula

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Probiotics

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

3 Days

Maximum Eligible Age

95 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Probi AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ProTolerance

Identifier Type: -

Identifier Source: org_study_id

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