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Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections

NCT ID: NCT01215656

Last Updated: 2010-10-07

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

PHASE2/PHASE3

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

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The objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants.

Detailed Description

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Conditions

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Incidence of Infectious Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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Probiotic

follow on formula with the probiotic Lactobacillus fermentum

Group Type EXPERIMENTAL

Lactobacillus fermentum

Intervention Type DIETARY_SUPPLEMENT

Control

follow on formula without probiotics

Group Type ACTIVE_COMPARATOR

Follow on formula without probiotics

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Lactobacillus fermentum

Intervention Type DIETARY_SUPPLEMENT

Follow on formula without probiotics

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 6 months old children born at term
* written consent from parents

Exclusion Criteria

* frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux)
* gastrointestinal surgery
* cow's milk protein allergy
* metabolic diseases (diabetes or lactose intolerance)
* immune deficiency
* antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)
Minimum Eligible Age

6 Months

Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Puleva Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Puleva Biotech

References

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Maldonado J, Canabate F, Sempere L, Vela F, Sanchez AR, Narbona E, Lopez-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respiratory tract infections in infants. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):55-61. doi: 10.1097/MPG.0b013e3182333f18.

Reference Type DERIVED
PMID: 21873895 (View on PubMed)

Other Identifiers

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L. fermentum infections

Identifier Type: -

Identifier Source: org_study_id