NCT01346644

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2011

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

First QC Date

May 1, 2011

Last Update Submit

May 15, 2013

Conditions

Tolerance

Keywords

Probioticinfant nutritionsafetyinfections

Outcome Measures

Primary Outcomes (1)

  • average weight gain

    4 months

Secondary Outcomes (1)

  • growth and health of infants

    2,4,6,12 and 36 months of life

Study Arms (2)

No probiotics

ACTIVE COMPARATOR

Infant formula with no probiotics

Other: Infant formula

Probiotic

EXPERIMENTAL

Infant formula supplemented with probiotic

Other: Infant formula

Interventions

Infant formulaOTHER

Powder infant formula

No probiotics

Eligibility Criteria

Age21 Days - 30 Days
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Healthy 1 month infants exclusively formula-fed

You may not qualify if:

  • gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux)
  • gastrointestinal surgery
  • cow's milk protein allergy
  • metabolic disorders (diabetes, lactose intolerance)
  • immune deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biosearch Life

Granada, Granada, 18004, Spain

Location

Related Publications (1)

  • Maldonado-Lobon JA, Gil-Campos M, Maldonado J, Lopez-Huertas E, Flores-Rojas K, Valero AD, Rodriguez-Benitez MV, Banuelos O, Lara-Villoslada F, Fonolla J, Olivares M. Long-term safety of early consumption of Lactobacillus fermentum CECT5716: A 3-year follow-up of a randomized controlled trial. Pharmacol Res. 2015 May-Jun;95-96:12-9. doi: 10.1016/j.phrs.2015.01.006. Epub 2015 Feb 16.

    PMID: 25697549DERIVED

MeSH Terms

Conditions

Infections

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Officials

  • Mercedes Gil, Doctor

    Hospital Reina Sofía de Córdoba (Spain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 1, 2011

First Posted

May 3, 2011

Study Start

February 1, 2009

Last Updated

May 16, 2013

Record last verified: 2013-05

Locations

ES(1)