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Completed

NCT Number: NCT05295030

Effects of Breast Milk Simulated Infant Formula

Objective：The aim of this trial is to assess effects of Kieember and Yashili infant formula on body growth, behavior development, intestinal comfort, infectious diseases, allergic diseases, the absorption of nutrients and gut microbiota as compared to breast-milk in term infants aged 0-3 months.

Participants：144 healthy term infants aged less than 30 days at entry to study. Study Design: A open-label,parallel, controlled trial.

Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2) Breast Milk Simulated Formula Group：fed with breast milk simulated infant formula (Ruibuen®Kieember, Phase I); (3) Traditional Formula Group: fed with traditional infant formula (Ruibuen®Yashili, Phase I).

Intervention Duration: 90 days.

Visits: 1month and 3month old.

Outcome measures: (1)Biochemical detection of feces (total fat, fatty acids, calcium, nitrogen);(2)Stool characteristics (frequency, color, volume, and stool consistency);(3)Anthropometric parameters (body length, body weight, and head circumferences);(4)Temperament and adaptive behavior;(5)Gut microbiota;(6)General health and wellbeing;(7)concomitant medications and adverse events.

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Key information

Conditions

Infant Formula Breast Milk

Age range

0 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Term infant: Born at 37-42 gestation weeks
  • Birth weight: 2500-4000g (appropriate for gestational age)
  • The infant is in good health and Apgar after 5 minutes >7
  • The mother had unequivocally decided not to breastfeed (for formula fed infants) or to breastfeed (for human milk fed infants)
  • age at the enrollment: less than 30 days

Exclusion criteria

  • The mother is unable to take care of her infant on account of health condition (psychological or physical) or socioeconomic problems
  • The infant is born with a congenital malformation or chromosome abnormality with a clinical significance
  • The infant suffers from a disease requiring mechanical ventilation or medication in the first week of life (not including applying phototherapy of blue to cure neonatal jaundice)
  • The infant whose feeding or normal metabolism is affected by any suspected or unknown metabolic factors or physical limitations
  • The infant has been breastfed for more than 2 weeks (for formula fed infants)
  • Twins or multiple births

Treatment and study plan

breast milk

Other

Breast milk: Human breast milk, provided and fed by the corresponding infant's mother

Kieember Infant formula, Ruibuen®

Other

Kieember Infant formula, Ruibuen®: a type of Phase I infant formula for 0-6 month infants, with a trademark of Ruibuen®. The formula is characterized by (1) OPO structured lipid of the third generation; and (2) Breast Milk Simulated complete structured lipid UPU. It was produced by Yashili New Zealand Dairy Co., Limited

Yashili Infant formula, Ruibuen®

Other

Yashili Infant formula, Ruibuen®: a type of Phase I infant formula for 0-6 month infants, with a trademark of Ruibuen®. The formula is characterized by(1) lactoferrin and(2) lutein . It was produced by Yashili International Holdings Ltd.,China

Primary outcomes

  1. Average Change Rate of Gut Microbiota Pattern Score from 1month to 3 month

    Time frame: 1,3 months

    Slope of change at 1 and 3 month in gut microbiota pattern score from 16S RNA sequencing.

  2. Average Change Rate of Fecal Residual Fatty Acid from 1month to 3 month

    Time frame: 1,3 months

    Slope of change at 1 and 3 month in Fecal Residual Fatty Acid.

  3. Average Change Rate of Fecal Residual Nitrogen from 1month to 3 month

    Time frame: 1,3 months

    Slope of change at 1 and 3 month in Fecal Residual Nitrogen.

  4. Average Change Rate of Fecal Residual Calcium from 1month to 3 month

    Time frame: 1,3 months

    Slope of change at 1 and 3 month in fecal residual calcium.

  5. Average Change Rate of body length from 1month to 3 month

    Time frame: 1,3 months

    Slope of change at 1 and 3 month in body length.

  6. Average Change Rate of body weight from 1month to 3 month

    Time frame: 1,3 months

    Slope of change at 1 and 3 month in body weigh.

  7. Average Change Rate of head circumferences from 1month to 3 month

    Time frame: 1,3 months

    Slope of change at 1 and 3 month in head circumferences.

Secondary outcomes

  1. Average Change Rate of Stool Characteristic Index from 1month to 3 month

    Time frame: 1,3 months

    Slope of change at 1 and 3 month in Stool Characteristic Index: calculated by using stool color (using sample pictures), stool shape (using sample pictures), and frequency.

  2. Average Change Rate of an Index of General health and wellbeing from 1month to 3 month

    Time frame: 1,3 months

    Slope of change at 1 and 3 month in Index of General health and wellbeing, calculated from diseases (cold, diarrhea,infectious diseases), doctor visits, concomitant medications,etc.

  3. Average Change Rate of Temperament Score from 1month to 3 month

    Time frame: 1,3 months

    Slope of change at 1 and 3 month in Temperament Score assessed by the Early Infant Temperament Scale

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Effects of Breast Milk Simulated Infant Formula: A 3-month Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2022
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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