Infant FormulaNCT05295030

Effects of Breast Milk Simulated Infant Formula

A study testing Breast milk, Kieember Infant formula, Ruibuen® and Yashili Infant formula, Ruibuen® in people with Infant Formula and Breast Milk, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 0 to 30 daysHealthy volunteers can take part
Conditions the study is for: Infant Formula, Breast Milk
What is being tested?: Breast milk, Kieember Infant formula, Ruibuen® and Yashili Infant formula, Ruibuen®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 179 participants
Where: 1 siteChina
Study dates: 10 Apr 2022to 25 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 0 to 30 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-sen University
Guangzhou, Guangdong, 510080

Other trials in China

About this study

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

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.

Conditions: Infant Formula, Breast Milk
Being tested: Breast milk, Kieember Infant formula, Ruibuen®, Yashili Infant formula, Ruibuen®
Keywords: gut microbiota, temperament, body growth, fecal residual nutrient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Breast milkOther
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

Study groups in NCT05295030
Study group	Role	What they receive
Breast Milk-Fed Group	Active comparator	The infants will be breastfed during the study. Receives: Other: Breast milk
Breast Milk Simulated Formula Group	Experimental	Kieember Infant formula, Ruibuen®: Infants will be fed Kieember infant formula(Phase I) from baseline (1 month old) to 3 month old. Receives: Other: Kieember Infant formula, Ruibuen®
Traditional Formula Group	Experimental	Yashili Infant formula, Ruibuen®: Infants will be fed Yashili infant formula (Phase I) from baseline (1 month old) to 3 month old. Receives: Other: Yashili Infant formula, Ruibuen®

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Change Rate of Gut Microbiota Pattern Score from 1month to 3 month
Slope of change at 1 and 3 month in gut microbiota pattern score from 16S RNA sequencing.
Measured: 1,3 months
Average Change Rate of Fecal Residual Fatty Acid from 1month to 3 month
Slope of change at 1 and 3 month in Fecal Residual Fatty Acid.
Measured: 1,3 months
Average Change Rate of Fecal Residual Nitrogen from 1month to 3 month
Slope of change at 1 and 3 month in Fecal Residual Nitrogen.
Measured: 1,3 months
Average Change Rate of Fecal Residual Calcium from 1month to 3 month
Slope of change at 1 and 3 month in fecal residual calcium.
Measured: 1,3 months
Average Change Rate of body length from 1month to 3 month
Slope of change at 1 and 3 month in body length.
Measured: 1,3 months
Average Change Rate of body weight from 1month to 3 month
Slope of change at 1 and 3 month in body weigh.
Measured: 1,3 months
Average Change Rate of head circumferences from 1month to 3 month
Slope of change at 1 and 3 month in head circumferences.
Measured: 1,3 months

Secondary outcomes (3)

Average Change Rate of Stool Characteristic Index from 1month to 3 month
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.
Measured: 1,3 months
Average Change Rate of an Index of General health and wellbeing from 1month to 3 month
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.
Measured: 1,3 months
Average Change Rate of Temperament Score from 1month to 3 month
Slope of change at 1 and 3 month in Temperament Score assessed by the Early Infant Temperament Scale
Measured: 1,3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 202225 Dec 2023

First posted24 Mar 2022
Study start10 Apr 2022
Primary completion25 Dec 2023
Study completion25 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infant FormulaStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 179 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05295030
Sponsor's protocol ID: MN-2022-01
Status last verified: Dec 2024
First submitted: 13 Mar 2022
Last updated: 27 Dec 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Qiu YZ, Yang MT, Liu Z, Chen XY, Chen JD, Huang SY, Lan QY, Hu Y, Zhou X, Wei W, Wang X, Ye X, Zhu HL. Impact of medium- and long-chain triacylglycerols and sn-2 palmitate on temperament development in term infants: potential role of gut Bifidobacterium. Food Funct. 2026 Mar 9;17(5):2399-2409. doi: 10.1039/d5fo03451e.
PubMed 41705972

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Recruiting
Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)
Growth
Recruiting
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
Healthy Term Infants
Not yet recruitingPhase 3
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
Infant ALL

All Infant Formula trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Breast Milk Simulated Infant Formula: A 3-month Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05295030
Acronym / sponsor ID: MN-2022-01
Conditions: Infant Formula, Breast Milk
Keywords: gut microbiota, temperament, body growth, fecal residual nutrient
Study type: Interventional
Recruitment status: Completed
Enrolment: 179 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 10 Apr 2022 (actual)
Primary completion: 25 Dec 2023 (actual)
Study completion: 25 Dec 2023 (actual)
First posted: 24 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Intervention Duration: 90 days.

Visits: 1month and 3month old.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Breast Milk-Fed Group	Active comparator	Other: Breast milkThe infants will be breastfed during the study.
Breast Milk Simulated Formula Group	Experimental	Other: Kieember Infant formula, Ruibuen®Kieember Infant formula, Ruibuen®: Infants will be fed Kieember infant formula(Phase I) from baseline (1 month old) to 3 month old.
Traditional Formula Group	Experimental	Other: Yashili Infant formula, Ruibuen®Yashili Infant formula, Ruibuen®: Infants will be fed Yashili infant formula (Phase I) from baseline (1 month old) to 3 month old.

Who may qualify

Ages: 0 to 30 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Breast milkBreast milk: Human breast milk, provided and fed by the corresponding infant's mother	Other	Breast Milk-Fed Group
Kieember Infant formula, Ruibuen®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	Other	Breast Milk Simulated Formula Group
Yashili Infant formula, Ruibuen®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	Other	Traditional Formula Group

Primary outcome

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.
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.
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.
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.
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.
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.
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.

3 secondary outcomes

Average Change Rate of Stool Characteristic Index from 1month to 3 month
Time frame: 1,3 months
Average Change Rate of an Index of General health and wellbeing from 1month to 3 month
Time frame: 1,3 months
Average Change Rate of Temperament Score from 1month to 3 month
Time frame: 1,3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
Derived from this study: PubMed 41705972Qiu YZ, Yang MT, Liu Z, Chen XY, Chen JD, Huang SY, Lan QY, Hu Y, Zhou X, Wei W, Wang X, Ye X, Zhu HL. Impact of medium- and long-chain triacylglycerols and sn-2 palmitate on temperament development in term infants: potential role of gut Bifidobacterium. Food Funct. 2026 Mar 9;17(5):2399-2409. doi: 10.1039/d5fo03451e.

Related trials for Infant Formula

RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Recruiting
Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)
Growth
Recruiting
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
Healthy Term Infants
Not yet recruitingPhase 3
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
Infant ALL

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Breast milk, Kieember Infant formula, Ruibuen® and Yashili Infant formula, Ruibuen® in people with Infant Formula and Breast Milk, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Change Rate of Gut Microbiota Pattern Score from 1month to 3 month (time frame: 1,3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05295030, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.