NCT01755481

Brief Summary

To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than 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

December 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

4.7 years

First QC Date

December 12, 2012

Last Update Submit

January 16, 2018

Conditions

Focus on Healthy Infants

Outcome Measures

Primary Outcomes (1)

  • Infections episodes (gastrointestinal and upper and lower respiratory infections)

    4 yrs

Study Arms (2)

Probiotics F19

EXPERIMENTAL

F19 in an infant formula

Other: Probiotic

Whey protein concentrate

EXPERIMENTAL

Whey protein concentrate in an infant formula

Other: Whey protein concentrate

Interventions

ProbioticOTHER
Probiotics F19
Whey protein concentrateOTHER
Whey protein concentrate

Eligibility Criteria

AgeUp to 2 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy infants of mothers who could not or voluntarily resigned completely from breast-feeding at infant age 14 plus/minus 3 days
  • healthy infants exclusively breast-fed from birth and mothers intending to breastfeed \>80% until at least 5th month of age (meaning through the 4th month of age).
  • delivered between 37 and 42 weeks of gestation birth weight \>2500 g and \<4000 g parent or the subject's legal representative speak and understand Chinese

You may not qualify if:

  • fully or partially breast-fed infants infants breast-fed \>20%
  • infants fed \>20% infant formula
  • malformations, handicaps or congenital diseases that could affect normal feeding or growth treatment with antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Child Health Care, Children's Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Interventions

ProbioticsWhey

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMilkBeveragesDairy Products

Study Officials

  • Yongmei Peng, M.D., Ph.D.

    Children's Hospital, Fudan University, Shanghai, China

    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

December 12, 2012

First Posted

December 24, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

CN(1)