NCT01215656

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
Last Updated

October 7, 2010

Status Verified

October 1, 2010

Enrollment Period

1.7 years

First QC Date

October 5, 2010

Last Update Submit

October 6, 2010

Conditions

Incidence of Infectious Diseases

Outcome Measures

Primary Outcomes (1)

  • Incidence of infectious diseases

Study Arms (2)

Probiotic

EXPERIMENTAL

follow on formula with the probiotic Lactobacillus fermentum

Dietary Supplement: Lactobacillus fermentum

Control

ACTIVE COMPARATOR

follow on formula without probiotics

Dietary Supplement: Follow on formula without probiotics

Interventions

Lactobacillus fermentumDIETARY_SUPPLEMENT
Probiotic
Follow on formula without probioticsDIETARY_SUPPLEMENT
Control

Eligibility Criteria

Age6 Months - 7 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • months old children born at term
  • written consent from parents

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21873895DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 5, 2010

First Posted

October 6, 2010

Study Start

May 1, 2008

Primary Completion

January 1, 2010

Last Updated

October 7, 2010

Record last verified: 2010-10