NCT02363582

Brief Summary

Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora.The purpose of this study is to investigate the stool characteristics,acceptability, and gastrointestinal tolerance in term infants fed a starting infant formula supplemented with prebiotics and lactoferrin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

January 31, 2015

Last Update Submit

April 20, 2016

Conditions

Infant Formula Intolerance

Outcome Measures

Primary Outcomes (1)

  • growth

    Head circumferences and weight gain

    6 weeks

Secondary Outcomes (2)

  • Gastrointestinal tolerance and safety

    6 weeks

  • intestinal microbiota

    6 weeks

Study Arms (2)

Breast fed

NO INTERVENTION

healthy term infants on exclusively breast feeding , enrollment age: 30-50days old

Formula fed

EXPERIMENTAL

healthy term infants on exclusively formula fed , enrollment age: 30-50days old

Other: formula

Interventions

formulaOTHER

An infant formula contains prebiotics and lactoferrin

Formula fed

Eligibility Criteria

Age5 Weeks - 7 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • full-term with a birth weight ≥2,500 g
  • be in good health
  • without symptoms of diarrhea, and had not received antibiotics for at least 1 week before enrollment
  • exclusively fed by breast milk or infant formula

You may not qualify if:

  • preterm infant
  • with known diseases or currently taking medication drugs
  • mixed feeding
  • with symptoms of diarrhea
  • received antibiotics within 1 week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xin Hua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Interventions

Food, Formulated

Intervention Hierarchy (Ancestors)

Foods, SpecializedFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jiang Wu, MD

    Xin Hua Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 31, 2015

First Posted

February 16, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

April 22, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)