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

Healthy Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520764
• Other study ID #: EBB16SI08406
• Status: Completed
• Phase: N/A
• Start date: April 3, 2018
• Est. completion date: November 9, 2020

Study information

• Verified date: February 2021
• Source: Danone Nutricia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: November 9, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 44 Days

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Infants

Intervention

Dietary Supplement:
• New infant formula with synbiotics
Infants are fed with synbiotics formula for 17 weeks from the date of enrollment.
• Standard infant formula with prebiotics
Infants are fed with prebiotics formula for 17 weeks from the date of enrollment.

Locations

Country	Name	City	State
China	Peking University 3rd Hospital	Beijing	Beijing
China	Guangdong Province Maternal and Children Hospital	Guangzhou	Guangdong
China	Guangzhou women and Children's Medical Center	Guangzhou	Guangdong
China	Shanghai Public Health Clinical Research Center	Shanghai	Shanghai
China	Xin Hua Hospital	Shanghai	Shanghai
China	Wuxi Poeple's Hospital	Wuxi	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Danone Nutricia	Nutricia Early Life Nutrition (Shanghai) Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

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