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Infant DevelopmentNCT04749290

Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants

A study testing Study Formula in people with Infant Development, run by Bunge Loders Croklaan at 2 sites 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

The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard… Read more about this study

Who is it for?
Ages 14 to 30 daysHealthy volunteers can take part
Conditions the study is for
Infant Development
What is being tested?
Study Formula
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
2 sitesChina
Study dates
1 Mar 2021to 15 Feb 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 14 to 30 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 30 days of age at randomization, inclusive (day of birth is considered day 0)
  • Exclusively formula-fed or partially bottle feeding with intake more than 650 ml /day for at least 3 days prior to randomization
  • Exclusively breast fed for at least 7 days prior to randomization
  • Singleton birth
  • Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks of gestational age)
  • Birth weight of 2500g to 4000g
  • Signed informed consent obtained for infant's participation in the study
  • Parent or guardian of infant agrees not to enroll infant in another interventional clinical research study while participating in this study

Who cannot join

  • History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
  • Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
  • Weight at Visit 1 is <95% of birth weight [(weight at Visit 1÷birth weight) x 100 <95%]
  • Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others
  • Participation in another clinical trial
  • Known or increased risk of cow's milk allergy and/ or lactose intolerance (i.e. one of the biological parents and or siblings diagnosed with cow's milk allergy, asthma, hay fever, etc.)
  • Having a mother suffering from diabetes during pregnancy
  • Use of antibiotics at the time of screening, or during the past two weeks

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • JiangNan Street Community Health Service Center, WuCheng District

    Jinhua

  • QiuBin Street Community Health Service Center, WuCheng District

    Jinhua

Other trials in China

About this study

Official title: Comparative Effects of Cow's Milk Based Infant Formula Containing Both OPO and CPP Versus Non-OPO Formula and Breast Feeding on Growth, Stool Consistency and Bone Strength: A Double-blinded, Randomized and Controlled Study

The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary objective is to compare the growth, tolerance, stool consistency and bone strength of infants randomized to the study infant formula (SF) versus infants randomized to the standard commercial infant formula (CF).

Read the detailed description

This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants. FF infants will be randomized to receive either a study infant formula, formulated for healthy term infants or a commercially available infant formula for healthy term infants. Infants will consume the formula for a total of 16-weeks; infant growth, tolerance, stool consistency and bone strength will be assessed throughout the study.

Being tested
Study Formula

What participants receive

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

  • Study FormulaOther

    Study infant formula for term infants containing OPO and CPP

Study groups in NCT04749290
Study groupRoleWhat they receive
Study FormulaExperimentala Cow's Milk Based Infant Formula Containing Both OPO and CPP for term infants (JunLeBao ZhiZhen)
Receives: Other: Study Formula
Comparator FormulaActive comparatorCommercially available infant formula without OPO for term infants (JunLeBao LeChun)
Receives: Other: Study Formula
Human Milk Reference GroupNo interventionHuman milk

What is being measured

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

  1. Stool characteristics

    Infant Stool Form Scale to measure stool consistency, amount and color (Bekkali et al, 2009): 4-point scale as watery (A) soft (B) formed (C) or hard (D)

    Measured: 1 month to 5 months

Secondary outcomes (11)

  1. Formula intake and tolerance (24 hour dietary recall)

    ml /day

    Measured: 2 months to 5 months

  2. Medically-diagnosed adverse events collected throughout the study period

    frequency

    Measured: 1 month to 5 months

  3. Crying and sleep tracking (24 hours recall)

    frequency

    Measured: 2 months to 5 months

  4. Gastrointestinal tract discomfort

    frequency of parents observed and documented GI tract discomfort

    Measured: 1 month to 5 months

  5. Anthropometric parameters on growth

    Achieved body length (CM)

    Measured: 1month to 5 months

  6. Anthropometric parameters on growth

    Achieved head circumferences (CM)

    Measured: 1month to 5 months

  7. Anthropometric parameters on growth

    Achieved body weight (kg)

    Measured: 1month to 5 months

  8. Bone Speed Of Sound

    Ultrasound Bone Densitometer (BMD-A3)

    Measured: at 1 month and 5 months

  9. Anthropometric parameters on growth

    Rate of gain (%) on achieved head circumferences

    Measured: 1month to 5 months

  10. Anthropometric parameters on growth

    Rate of gain (%) on achieved body weight

    Measured: 1month to 5 months

  11. Anthropometric parameters on growth

    Rate of gain (%) on achieved body length

    Measured: 1month to 5 months

Timeline

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

  1. First posted11 Feb 2021
  2. Study start1 Mar 2021
  3. Primary completion1 Oct 2022
  4. Study completion15 Feb 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04749290
Sponsor's protocol ID
20-SM-09-Bunge-001
Status last verified
May 2024
First submitted
30 Jan 2021
Last updated
16 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sheng XY, Mi W, Yuan QB, Liu BY, Carnielli V, Ning YB, Einerhand AWC. An A2 beta-casein infant formula with high sn-2 palmitate and casein phosphopeptides supports adequate growth, improved stool consistency, and bone strength in healthy, term Chinese infants: a randomized, double-blind, controlled clinical trial. Front Nutr. 2024 Aug 14;11:1442584. doi: 10.3389/fnut.2024.1442584. eCollection 2024.

    PubMed 39206307

Questions about this trial

What is this clinical trial studying?

A study testing Study Formula in people with Infant Development, run by Bunge Loders Croklaan at 2 sites 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 8 inclusion and 8 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Stool characteristics (time frame: 1 month to 5 months). 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 NCT04749290, 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 16 May 2024.

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