NCT02096302

Brief Summary

The purpose of this study is to determine whether an infant formula supplemented with a new probiotic CECT7210, is effective in reducing the incidence of infections, specially the gastrointestinal ones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

January 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

1.8 years

First QC Date

March 20, 2014

Last Update Submit

July 17, 2019

Conditions

Gastrointestinal Diseases

Keywords

ProbioticsInfant FormulaMicrobiotaBifidobacterium longum biovar infantis CECT7210Growth

Outcome Measures

Primary Outcomes (1)

  • Changes in diarrhea incidence

    Differences between diarrhea incidence amongst groups from baseline to 12th weeks.

    At 4th, 8th, 12th weeks

Secondary Outcomes (5)

  • Changes in infections incidence

    At 4th, 8th, 12th weeks.

  • Changes in microbiota

    At 4th, 8th, 12th weeks

  • Changes in Immunoglobulin A secretor (IgAs)

    At 4th and 12th weeks

  • Tolerability of the product

    At 4th, 8th and 12th weeks

  • Growth

    At 4th, 8th and 12th weeks

Study Arms (2)

Experimental Formula

EXPERIMENTAL

Infant formula with a novel probiotic CECT7210

Dietary Supplement: Infant Formula with a novel probiotic CECT7210

Standard Formula

ACTIVE COMPARATOR

Standard infant formula without probiotics

Dietary Supplement: Standard formula

Interventions

Infant Formula with a novel probiotic CECT7210DIETARY_SUPPLEMENT

Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.

Experimental Formula
Standard formulaDIETARY_SUPPLEMENT

Standard formula without probiotics

Standard Formula

Eligibility Criteria

AgeUp to 90 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Full-term healthy newborns (\>= 37 weeks)
  • Birth weight between \>=2.500g and \<=4.500g)
  • Normal growth curve (between 3-97 percentiles)
  • days of age on enrolment
  • Maximum 30 days of breastfeeding
  • Exclusively infant formula on enrolment
  • Breastfeeding or infant formula with pre/probiotics feeding stopped 15 days before enrolment
  • Parents or caregivers agree to exclude any source of prebiotics or probiotics during the study
  • Parents or caregivers agree to follow-on the study 12 weeks
  • Informed consent signed ( Parent/Legal representative)

You may not qualify if:

  • Congenital illness or malformation that may affect infant feeding and /or normal growth
  • Significant pre-natal or post-natal diseases
  • Infant's family history of atopy
  • Any pathology related to the immune or gastrointestinal system.
  • Suspected or known allergy to cow's milk protein
  • Infants receiving pre or probiotics within less than 15 days prior to enrolment
  • Infant's family who in the investigator's assessment cannot be expected to comply with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Sant Joan de Reus

Reus, Tarragona, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Joan XXIII

Tarragona, Spain

Location

Related Publications (2)

  • Closa R, Ferré N, Luque V, Gispert-Llaurado M, Ruibio-Torrents C, Polanco I, Morera M, Moreno JA, Rivero M, Escribano J. Effect of probiotic CECT7210 supplementation of infant formula in healthy infants. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PA-N-0038.

    RESULT

  • Moreno JA, Cifuentes GC, Morera M, Martínez-Blach JF, Codoñer F, Genovés S, Chenoll E, Polanco I, Closa R, Escribano J, Ferré N, Luque V, Rivero M. Feeding infant formula supplemented with the probiotic bacteria bifidobacterium longum subsp.infantis CECT7210 produce beneficial changes in gastointestinal microbial communities: a metagenomic approach. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PO-N-0361.

    RESULT

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Infant Formula

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Isabel Polanco, Professor

    Hospital Universitario La Paz

    STUDY CHAIR

  • Joaquin Escribano, Professor

    Hospital Sant Joan de Reus, Reus, Spain

    PRINCIPAL INVESTIGATOR

  • Ricardo Closa, Professor

    Hospital Joan XXIII de Tarragona, Tarragona, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 26, 2014

Study Start

January 1, 2011

Primary Completion

November 1, 2012

Study Completion

June 1, 2013

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations

ES(3)