Healthy InfantsNCT04733937
Comparative Effects of A2 Platinum Stage 1 Infant Formula on Infant Digestion and Comfort
A study testing a2 Platinum® stage 1 infant formula and Conventional, A1 and A2 β-casein containing stage 1 infant formula in people with Healthy Infants, run by a2 Milk Company Ltd. at 5 sites in China.
Trial summary
This trial is a single-blind, randomized, controlled, parallel-designed trial to compare the effects of a2 Platinum® stage 1 infant formula versus conventional, A1 and A2 β-casein-containing stage 1 infant formula versus breastfeeding on crying, tolerance, gut health, and immune function. Read more about this study
- Who is it for?
- Ages 0 to 76 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- a2 Platinum® stage 1 infant formula and Conventional, A1 and A2 β-casein containing stage 1 infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 5 sitesChina
- Study dates
- 7 Jul 2021to 16 Apr 2022
- 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 76 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 0-76 days of age after birth, inclusive (day of birth is considered day 0)
- Singleton birth
- Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
- Birth weight of 2,500 g to 4,500 g
- Signed informed consent obtained for infant's participation in the survey
- Parent or guardian of infant agrees not to enrol infant in another interventional clinical survey while participating in this survey
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- Parent or guardian agrees to formula-feed the baby as per the randomization schedule
- For the formula-fed groups, participants in addition to the above-listed criteria, must also meet the following criterion:
- Parent or guardian agrees that the baby will be fed with standardized formula upon enrolment and switched to randomized formula at baseline (90-105 days of age)
- For the breastfed group, participants in addition to the above-listed criteria, must also meet the following criterion:
- Parent or guardian agrees that the baby will be breast-fed
Who cannot join
- Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases that could interfere with the survey (e.g. being unable to breast-feed or formula-fed)
- Diseases jeopardizing intrauterine growth
- Known or increased risk of IgE-mediated cow's milk protein allergy
- (i.e. one of the biological parents and/or siblings diagnosed with similar allergy,
- asthma, hay fever, etc.)
- Infant with an acute infection or gastroenteritis at time of randomization
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- Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake at time of randomization
- Participation in another clinical trial
- Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements (including to fill in the diaries and to wait with introducing weaning foods until 4 months of age, and capability and willingness to do stool sample collection, handling, processing, and storage as instructed)
- Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiencies 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
- Exit Criteria:
- Ineligibility (either arising during the trial or retrospectively having been overlooked at screening)
- Significant protocol deviation
- Significant non-compliance with product regimen or trial requirements
- An adverse event (including one occurring before the start of the trial period) which requires discontinuation of the trial product or results in inability to continue to comply with trial procedures
- Disease progression which requires discontinuation of the trial product or results in inability to continue to comply with trial procedures
- Withdrawal of Consent
- Lost to follow up
- Weight at Visit 2 is <95% of birth weight [(weight at Visit 2÷birth weight) x 100 <95%]
- Use of antibiotics, steroids or prebiotics/probiotics anytime between 14 days before baseline and trial completion
- Participant whose mother has used any form of antibiotics or steroids while breastfeeding
- More than 1 feed of formula milk per day for the breastfed group
- More than 2 feeds of breast milk per day for the formula groups
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Second Hospital of Jilin University
Changchun, Jilin, 130041
Women & Children's Health Care Hospital of Linyi, China
Linyi, Shandong, 276000
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 200121
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300192
About this study
Official title: Protocol Title: Comparative Effects of A2 Platinum® Stage 1 Infant Formula Versus Conventional Stage 1 Infant Formula Containing A1 and A2 Β-casein Versus Breast Feeding on Infant Digestion and Comfort: a Single-blind Randomized Controlled Trial
This trial is a single-blind, randomized, controlled, parallel-designed trial to compare the effects of a2 Platinum® stage 1 infant formula versus conventional, A1 and A2 β-casein-containing stage 1 infant formula versus breastfeeding on crying, tolerance, gut health, and immune function.
Read the detailed description
The protocol was updated from V8.2 to V9.1 and was approved by the Ethical Committee of Shanghai First Maternity and Infant Hospital, the main site. The major changes are: from "blind to participants" to "non-blind to participants"; from "Single-Centre" to "Multi-Centre"; number of subjects from "270" to "180"; trial period from "3 weeks" to "4 weeks"; and number of visits from "6" to "4".
- Conditions
- Healthy Infants
- Being tested
- a2 Platinum® stage 1 infant formula, Conventional, A1 and A2 β-casein containing stage 1 infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a2 Platinum® stage 1 infant formulaOther
Upon randomization (if not included in the breastfed group), each participant will be provided with up to 105 days' supply of the standardized formula and up to 28 days' supply of the allocated formula. Participants and study investigators will conduct the trial via a pre-determined randomization schedule.
Conventional, A1 and A2 β-casein containing stage 1 infant formulaOther
Upon randomization (if not included in the breastfed group), each participant will be provided with up to 105 days' supply of the standardized formula and up to 28 days' supply of the allocated formula. Participants and study investigators will conduct the trial via a pre-determined randomization schedule.
| Study group | Role | What they receive |
|---|---|---|
| a2 Group | Active comparator | The infant group consuming a2 Platinum® stage 1 infant formula Receives: Other: a2 Platinum® stage 1 infant formula |
| Control Group | Active comparator | The infant group consuming conventional, A1 and A2 β-casein containing stage 1 infant formula Receives: Other: Conventional, A1 and A2 β-casein containing stage 1 infant formula |
| breast feeding | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of crying frequency at each follow up visit compared to baseline
Record frequency of crying (times/d)
Measured: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)
Changes of crying duration at each follow up visit compared to baseline
Record duration of crying (min)
Measured: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Changes in fecal MPO levels at each follow up visit compared to baseline
Record fecal MPO (in Unit) as markers of inflammation
Measured: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Secondary outcomes (6)
Changes in salivary cortisol levels at each follow up visit compared to baseline
Record salivary cortisol (nmol/L) as markers of immune function
Measured: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Changes in body length
Differences in length gain (cm/d)
Measured: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)
Changes in body weight
Differences in weight gain (kg/d)
Measured: Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Changes in head circumference
Differences in head circumference (cm/d)
Measured: Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Number of adverse events at each follow up visit compared to baseline
Record number of adverse events as a measure of safety and tolerability
Measured: Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Abundance analysis of gut microflora species
Differences in abundance of gut microflora species
Measured: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start7 Jul 2021
- Primary completion16 Apr 2022
- Study completion16 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- a2 Milk Company Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai First Maternity and Infant Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Edanz Group Japan Ltd, Women & Children's Health Care Hospital of Linyi, China, Beijing Esmile Technology Co. Ltd., Nanjing Maternity and Child Health Care Hospital, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Second Hospital of Jilin University
- Responsible party
- Sponsor
- Investigators
- Jiangqin Liu, MD, Principal investigator, Shanghai First Maternity and Infant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733937
- Sponsor's protocol ID
- A2MC-G190549140
- Status last verified
- Oct 2024
- First submitted
- 20 Jan 2021
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Title: Comparative Effects of A2 Platinum® Stage 1 Infant Formula Versus Conventional Stage 1 Infant Formula Containing A1 and A2 Β-casein Versus Breast Feeding on Infant Digestion and Comfort: a Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04733937
- Acronym / sponsor ID
- A2MC-G190549140
- Conditions
- Healthy Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- a2 Milk Company Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai First Maternity and Infant Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Edanz Group Japan Ltd, Women & Children's Health Care Hospital of Linyi, China, Beijing Esmile Technology Co. Ltd., Nanjing Maternity and Child Health Care Hospital, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Second Hospital of Jilin University
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 16 Apr 2022 (actual)
- Study completion
- 16 Apr 2022 (actual)
- First posted
- 2 Feb 2021 (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.
This trial is a single-blind, randomized, controlled, parallel-designed trial to compare the effects of a2 Platinum® stage 1 infant formula versus conventional, A1 and A2 β-casein-containing stage 1 infant formula versus breastfeeding on crying, tolerance, gut health, and immune function.
Detailed description
The protocol was updated from V8.2 to V9.1 and was approved by the Ethical Committee of Shanghai First Maternity and Infant Hospital, the main site. The major changes are: from "blind to participants" to "non-blind to participants"; from "Single-Centre" to "Multi-Centre"; number of subjects from "270" to "180"; trial period from "3 weeks" to "4 weeks"; and number of visits from "6" to "4".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| a2 Group | Active comparator | Other: a2 Platinum® stage 1 infant formulaThe infant group consuming a2 Platinum® stage 1 infant formula |
| Control Group | Active comparator | Other: Conventional, A1 and A2 β-casein containing stage 1 infant formulaThe infant group consuming conventional, A1 and A2 β-casein containing stage 1 infant formula |
| breast feeding | No intervention | – |
Who may qualify
- Ages
- 0 to 76 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 0-76 days of age after birth, inclusive (day of birth is considered day 0)
- Singleton birth
- Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
- Birth weight of 2,500 g to 4,500 g
- Signed informed consent obtained for infant's participation in the survey
Key exclusion criteria (23 listed)
- Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases that could interfere with the survey (e.g. being unable to breast-feed or formula-fed)
- Diseases jeopardizing intrauterine growth
- Known or increased risk of IgE-mediated cow's milk protein allergy
- Infant with an acute infection or gastroenteritis at time of randomization
- Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake at time of randomization
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 |
|---|---|---|
| a2 Platinum® stage 1 infant formulaUpon randomization (if not included in the breastfed group), each participant will be provided with up to 105 days' supply of the standardized formula and up to 28 days' supply of the allocated formula. Participants and study investigators will conduct the trial via a pre-determined randomization schedule. | Other | a2 Group |
| Conventional, A1 and A2 β-casein containing stage 1 infant formulaUpon randomization (if not included in the breastfed group), each participant will be provided with up to 105 days' supply of the standardized formula and up to 28 days' supply of the allocated formula. Participants and study investigators will conduct the trial via a pre-determined randomization schedule. | Other | Control Group |
Primary outcome
Changes of crying frequency at each follow up visit compared to baseline
Time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)
Record frequency of crying (times/d)
Changes of crying duration at each follow up visit compared to baseline
Time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Record duration of crying (min)
Changes in fecal MPO levels at each follow up visit compared to baseline
Time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Record fecal MPO (in Unit) as markers of inflammation
6 secondary outcomes
Changes in salivary cortisol levels at each follow up visit compared to baseline
Time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Changes in body length
Time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)
Changes in body weight
Time frame: Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Changes in head circumference
Time frame: Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Number of adverse events at each follow up visit compared to baseline
Time frame: Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Abundance analysis of gut microflora species
Time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)
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 18 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Jiangqin Liu, MD principal investigator
Shanghai First Maternity and Infant Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a2 Platinum® stage 1 infant formula and Conventional, A1 and A2 β-casein containing stage 1 infant formula in people with Healthy Infants, run by a2 Milk Company Ltd. at 5 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 11 inclusion and 23 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 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Changes of crying frequency at each follow up visit compared to baseline (time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2024.