Effect of Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on Growth and Development of Infants

ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-28
SponsorHeilongjiang Feihe Dairy Co. Ltd.

About this trial

The research objective is to compare the effects of infant formula supplemented with milk oligosaccharides and optimized with multiple nutrients on the immune function of infants under 1 year old with conventional infant formula, and to compare the effects of different infant formulas on infant intestinal health, immune function, growth and development, cognitive development, and tolerance with those of breastfed infants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

0-28 days after birth;

Single birth;

The gestational age is between 37 and 42 weeks;

Birth weight ranges from 2500 to 4000 grams;

Disqualifiers

Artificial assisted reproduction;

The mother suffers from a disease that may endanger intrauterine growth;

The mother suffers from pregnancy diabetes or serious metabolic disease or chronic disease during pregnancy

Suffering from congenital malformations and genetic diseases, chronic diseases, and congenital diseases that may interfere with the investigation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • oligosaccharides and multiple nutrients

    Dietary supplement

    The effect of adding milk oligosaccharides and optimizing multiple nutrients to infant formula on the growth and development of infants aged 0-1 years

  • no oligosaccharides and optimizing multiple nutrients

    Dietary supplement

    The effect of traditional infant formula milk powder optimized without adding milk oligosaccharides and multiple nutrients on the growth and development of infants aged 0-1 years old.

  • breastfeeding

    Dietary supplement

    The impact of breastfeeding on the growth and development of infants aged 0-1 years old.

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: experimental groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention
Group C: Breastfeeding groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intestinal indicators

16s rRNA

Time frame
day 28,180,360
2

Intestinal indicators

SCFAs

Time frame
day 28,180,360

Secondary outcomes

1

Inflammatory markers

serum hsCRP

Time frame
day 180,360
2

Nutritional indicators

serum albumin

Time frame
day 180,360
3

Immune indicators

fecal sIgA

Time frame
day 28,180,360
4

Immune indicators

blood lymphocyte subsets

Time frame
day 180,360

Other outcomes

1

adverse event

adverse event

Time frame
1 year
2

Serious adverse events

Serious adverse events

Time frame
1 year

Sponsors and contacts

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