To Investigate Effects of a New Infant Formula in Healthy Term Chinese Infants

A Randomised, Controlled, Double-blind Study to Investigate the Effects of a New Infant Formula on Growth, Safety, and Tolerance in Healthy Term Chinese Infants

This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants.

Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits.

Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age.

Safety, growth and tolerance parameters will be followed and collected throughout the study.

Study Overview

• Status: Completed
• Conditions: Healthy Infants
• Intervention / Treatment: Dietary supplement: New infant formula with synbiotics; Dietary supplement: Standard infant formula with prebiotics

• Study Type: Interventional
• Enrollment (Actual): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University 3rd Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510623
      • Guangzhou Women And Children's Medical Center
    • Guangzhou, Guangdong, China
      • Guangdong Province Maternal and Children Hospital
  • Jiangsu
    • Wuxi, Jiangsu, China
      • Wuxi Poeple's Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Public Health Clinical Research Center
    • Shanghai, Shanghai, China
      • Xin Hua Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy Chinese term infants ≤ 44 days
2. Birth weight within normal range
3. Head circumference within normal range
4. Fully formula fed by the time of randomization OR fully breastfed and with intention to fully breastfeed until 17 weeks of age

Exclusion Criteria:

- The mothers of infants:

1. who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;

2. known to have a significant medical condition that might interfere with the study or known to affect intra-uterine growth, as per investigator's clinical judgement;

   - Parents/Legally acceptable representatives/Caregivers of infants:

3. who are incapable to comply with study protocol

   - Infants:

4. who have to be fed with a special diet other than standard cow's milk based infant formula;
5. known to have current or previous illnesses/conditions which could interfere with the study products or its outcome parameters
6. known or suspected to have an allergic condition towards cow's milk, soy or fish;
7. with any history of, or current participation in any other study involving investigational or marketed products.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: New infant formula with synbiotics; pHP infant formula with synbiotics (test product)	Dietary supplement: New infant formula with synbiotics; Infants are fed with synbiotics formula for 17 weeks from the date of enrollment.
ACTIVE_COMPARATOR: Standard infant formula with prebiotics; Standard (commercial) infant formula with prebiotics (control product)	Dietary supplement: Standard infant formula with prebiotics; Infants are fed with prebiotics formula for 17 weeks from the date of enrollment.
NO_INTERVENTION: human milk; Full breastfeeding for at least 17 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight gain per day from baseline (g/day)	at the age of 17 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight gain per day from baseline (g/day) in infant receiving test product compared to breastfed infant.	at the age of 17 weeks
Increment per day from baseline on length (mm/day)	at the age of 17 weeks
Increment per day from baseline on head circumference (mm/day)	at the age of 17 weeks
Increment per day from baseline on mid-upper arm circumference (mm/day)	at the age of 17 weeks
Z-scores of anthropometric parameters from baseline on weight	from baseline until the age of 17 weeks
Z-scores of anthropometric parameters from baseline on length	from baseline until the age of 17 weeks
Z-scores of anthropometric parameters from baseline on head circumference	from baseline until the age of 17 weeks
Z-scores of anthropometric parameters from baseline on mid-upper arm circumference	from baseline until the age of 17 weeks
Effect on incidence, frequency and severity of (serious) adverse events	from baseline until the age of 17 weeks
Parent-reported occurrence of diarrhea	from baseline until the age of 17 weeks
Parent-reported severity of diarrhea	from baseline until the age of 17 weeks
Parent-reported occurrence of constipation	from baseline until the age of 17 weeks
Parent-reported severity of constipation	from baseline until the age of 17 weeks

Collaborators and Investigators

• Sponsor: Danone Nutricia
• Collaborators: Nutricia Early Life Nutrition (Shanghai) Co., Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 3, 2018
• Primary Completion (ACTUAL): March 6, 2020
• Study Completion (ACTUAL): November 9, 2020

Study Registration Dates

• First Submitted: March 11, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (ACTUAL): May 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: EBB16SI08406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No