Safety of Lactobacillus Fermentum in Newborn Infants

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

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Brief Summary

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In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.

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Detailed Description

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Conditions

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Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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No probiotics

Infant formula with no probiotics

Group Type ACTIVE_COMPARATOR

Infant formula

Intervention Type OTHER

Powder infant formula

Probiotic

Infant formula supplemented with probiotic

Group Type EXPERIMENTAL

Infant formula

Intervention Type OTHER

Powder infant formula

Interventions

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Infant formula

Powder infant formula

Intervention Type OTHER

Infant formula

Powder infant formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy 1 month infants exclusively formula-fed

Exclusion Criteria

* gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux)
* gastrointestinal surgery
* cow's milk protein allergy
* metabolic disorders (diabetes, lactose intolerance)
* immune deficiency
* antibiotic prescription 1-week prior to inclusion and previous use of formula containing prebiotics or probiotics

Minimum Eligible Age

21 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No