Healthy GrowthStardustNCT04066413
Growth and Tolerance Trial on Infant Formula With HMO
A study testing Standard infant formula and Infant formula supplemented with HMO in people with Healthy Growth, run by FrieslandCampina at 1 site in United States.
Trial summary
The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula. Read more about this study
- Who is it for?
- Ages Up to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Healthy Growth
- What is being tested?
- Standard infant formula and Infant formula supplemented with HMO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 26 Jan 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 Up to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age ≥ 37 weeks
- Birth weight ≥ 2500 grams
- No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases)
- Boys and girls
- Recruited < 1 month/age
- Being available for follow up until the age of 4 months
- Exclusive formula feeding or exclusive breast feeding at time of recruitment
Who cannot join
- Gestational age <37 weeks
- Birth weight <2500 grams
- Severe acquired or congenital diseases, mental or physical disorders
- Illness at screening/ inclusion
- Incapability of parents/caregivers to comply with the study protocol
- Received antibiotics within the first month of life
Show all 10Show fewer
- Not tolerating standard cow's milk based infant formula
- Participation in another clinical trial
- Maternal illicit drug use during pregnancy or post-partum period
- Parent/caregiver does not have a cell phone to use for filling out questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3026
About this study
Official title: Growth and Tolerance Trial in Healthy Infants on Infant Formula Supplemented With a Human Milk Oligosaccharide
The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.
- Conditions
- Healthy Growth
- Being tested
- Standard infant formula, Infant formula supplemented with HMO
- Keywords
- infant formula, human milk oligosaccharide, HMO, growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard infant formulaOther
Standard infant formula
Infant formula supplemented with HMOOther
Infant formula supplemented with HMO
| Study group | Role | What they receive |
|---|---|---|
| Breastfed group | No intervention | Non-randomized breastfed reference group |
| Control formula | Placebo comparator | Group receiving standard infant formula Receives: Other: Standard infant formula |
| Formula with HMO | Active comparator | Group receiving standard infant formula supplemented with HMO Receives: Other: Infant formula supplemented with HMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
Infant growth measured as body weight gain per day
Measured: From enrollment until end of the 3 month-study
Secondary outcomes (6)
Weight
Infant weight (kg)
Measured: Monthly, from enrollment until end of the 3 month-study
Recumbent length
Infant length (cm and cm/day)
Measured: Monthly, from enrollment until end of the 3 month-study
Head circumference
Head circumference (cm and cm/day)
Measured: Monthly, from enrollment until end of the 3 month-study
Anthropometry z-scores
World Health Organization (WHO) growth standard calculated z-scores for weight, length, weight-for-length and head circumference
Measured: Monthly, from enrollment until end of the 3 month-study
Formula tolerance
Parents are asked to keep a diary on formula intake 3 days prior to each monthly study visit
Measured: Monthly, from enrollment until end of the 3 month-study
Gastro-intestinal comfort
Parents are asked to keep a diary 3 days prior to each monthly study visit including questions on gastro-intestinal symptoms (e.g. cramps, constipation, vomiting) and crying behavior
Measured: Monthly, from enrollment until end of the 3 month-study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start23 Sep 2019
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
Why it stopped: Due to recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy GrowthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- FrieslandCampina
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066413
- Sponsor's protocol ID
- Stardust
- Acronym
- Stardust
- Status last verified
- Sep 2023
- First submitted
- 21 Aug 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance Trial in Healthy Infants on Infant Formula Supplemented With a Human Milk Oligosaccharide
- ClinicalTrials.gov ID
- NCT04066413
- Acronym / sponsor ID
- Stardust / Stardust
- Conditions
- Healthy Growth
- Keywords
- infant formula, human milk oligosaccharide, HMO, growth
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to recruitment difficulties
- Enrolment
- 265 participants (actual)
- Lead sponsor
- FrieslandCampinaIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 26 Aug 2019 (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.
The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breastfed group | No intervention | –Non-randomized breastfed reference group |
| Control formula | Placebo comparator | Other: Standard infant formulaGroup receiving standard infant formula |
| Formula with HMO | Active comparator | Other: Infant formula supplemented with HMOGroup receiving standard infant formula supplemented with HMO |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Gestational age ≥ 37 weeks
- Birth weight ≥ 2500 grams
- No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases)
- Boys and girls
- Recruited < 1 month/age
Key exclusion criteria (10 listed)
- Gestational age <37 weeks
- Birth weight <2500 grams
- Severe acquired or congenital diseases, mental or physical disorders
- Illness at screening/ inclusion
- Incapability of parents/caregivers to comply with the study protocol
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 |
|---|---|---|
| Standard infant formulaStandard infant formula | Other | Control formula |
| Infant formula supplemented with HMOInfant formula supplemented with HMO | Other | Formula with HMO |
Primary outcome
Growth
Time frame: From enrollment until end of the 3 month-study
Infant growth measured as body weight gain per day
6 secondary outcomes
Weight
Time frame: Monthly, from enrollment until end of the 3 month-study
Recumbent length
Time frame: Monthly, from enrollment until end of the 3 month-study
Head circumference
Time frame: Monthly, from enrollment until end of the 3 month-study
Anthropometry z-scores
Time frame: Monthly, from enrollment until end of the 3 month-study
Formula tolerance
Time frame: Monthly, from enrollment until end of the 3 month-study
Gastro-intestinal comfort
Time frame: Monthly, from enrollment until end of the 3 month-study
Results and safety
The study was stopped early (reason given: Due to recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- 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.
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 Standard infant formula and Infant formula supplemented with HMO in people with Healthy Growth, run by FrieslandCampina at 1 site in United States.
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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 28 Sep 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Due to recruitment difficulties). Results are not available in the source record.
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?
Growth (time frame: From enrollment until end of the 3 month-study). 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 28 Sep 2023.