MetabolomicsNCT02948114
The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics
A study testing Experimental 1: Cow milk-based infant formula, Experimental 2: Cow milk-based infant formula and Experimental 3: Cow milk-based infant formula in people with Metabolomics, run by Mead Johnson Nutrition at 1 site in China.
Trial summary
The study is intended to evaluate the microorganisms found in infant stools when consuming study formulas containing prebiotics and/or probiotics compared to infants consuming mother's own breast milk. Read more about this study
- Who is it for?
- Ages 10 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Metabolomics
- What is being tested?
- Experimental 1: Cow milk-based infant formula, Experimental 2: Cow milk-based infant formula and Experimental 3: Cow milk-based infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Apr 2017
- 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 10 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton, 10-14 days of age at registration/randomization
- Term infant with birth weight of 2500 grams or more from a vaginal birth
- Formula feeding infants must be on formula for at least 3 days
- Human milk fed infants must have received mother's own breast milk from 1 day of age to study registration and mother has intention to exclusively provide mother's own breast milk for the duration of the study
- Signed informed consent
Who cannot join
- History of underlying metabolic or chronic disease or immune compromised
- Feeding difficulties or formula intolerance
Trial locations and contacts
1 site in 1 country.
About this study
The study is intended to evaluate the microorganisms found in infant stools when consuming study formulas containing prebiotics and/or probiotics compared to infants consuming mother's own breast milk.
- Conditions
- Metabolomics
- Being tested
- Control: Cow milk-based infant formula, Experimental 1: Cow milk-based infant formula, Experimental 2: Cow milk-based infant formula, Experimental 3: Cow milk-based infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control: Cow milk-based infant formulaOther
Experimental 1: Cow milk-based infant formulaOther
Experimental 1: Cow milk-based infant formula with prebiotics
Experimental 2: Cow milk-based infant formulaOther
Experimental 2: Cow milk-based infant formula with probiotics
Experimental 3: Cow milk-based infant formulaOther
Experimental 3: Cow milk-based infant formula with prebiotics and probiotics
| Study group | Role | What they receive |
|---|---|---|
| Control: Cow milk-based infant formula | Active comparator | Cow milk-based infant formula Receives: Other: Control: Cow milk-based infant formula |
| Experimental 1: Cow milk-based infant formula | Experimental | Cow milk-based infant formula with prebiotics Receives: Other: Experimental 1: Cow milk-based infant formula |
| Experimental 2: Cow milk-based infant formula | Experimental | Cow milk-based infant formula with probiotics Receives: Other: Experimental 2: Cow milk-based infant formula |
| Experimental 3: Cow milk-based infant formula | Experimental | Cow milk-based infant formula with prebiotics and probiotics Receives: Other: Experimental 3: Cow milk-based infant formula |
| Human Milk Reference | No intervention | Human Milk Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal microbiota
Measured: 3.5 months
Secondary outcomes (6)
Body Weight measured at each study visit
Measured: Up to 3.5 months
Body Length measured at each study visit
Measured: Up to 3.5 months
Head circumference measured at each study visit
Measured: Up to 3.5 months
Recall of infant formula usage at each study visit
Measured: Up to 3.5 months
Recall of gastrointestinal tolerance questionnaire at each study visit
Measured: Up to 3.5 months
Medically-confirmed adverse events collected throughout the study period
Measured: Up to 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolomicsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Kangchen Technologies
- Responsible party
- Sponsor
- Investigators
- Steven Wu, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948114
- Sponsor's protocol ID
- 6026
- Status last verified
- Aug 2018
- First submitted
- 26 Oct 2016
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics
- ClinicalTrials.gov ID
- NCT02948114
- Acronym / sponsor ID
- 6026
- Conditions
- Metabolomics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Kangchen Technologies
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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 study is intended to evaluate the microorganisms found in infant stools when consuming study formulas containing prebiotics and/or probiotics compared to infants consuming mother's own breast milk.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control: Cow milk-based infant formula | Active comparator | Other: Control: Cow milk-based infant formulaCow milk-based infant formula |
| Experimental 1: Cow milk-based infant formula | Experimental | Other: Experimental 1: Cow milk-based infant formulaCow milk-based infant formula with prebiotics |
| Experimental 2: Cow milk-based infant formula | Experimental | Other: Experimental 2: Cow milk-based infant formulaCow milk-based infant formula with probiotics |
| Experimental 3: Cow milk-based infant formula | Experimental | Other: Experimental 3: Cow milk-based infant formulaCow milk-based infant formula with prebiotics and probiotics |
| Human Milk Reference | No intervention | –Human Milk Reference |
Who may qualify
- Ages
- 10 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Singleton, 10-14 days of age at registration/randomization
- Term infant with birth weight of 2500 grams or more from a vaginal birth
- Formula feeding infants must be on formula for at least 3 days
- Human milk fed infants must have received mother's own breast milk from 1 day of age to study registration and mother has intention to exclusively provide mother's own breast milk for the duration of the study
- Signed informed consent
Key exclusion criteria (2 listed)
- History of underlying metabolic or chronic disease or immune compromised
- Feeding difficulties or formula intolerance
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 |
|---|---|---|
| Control: Cow milk-based infant formula | Other | Control: Cow milk-based infant formula |
| Experimental 1: Cow milk-based infant formulaExperimental 1: Cow milk-based infant formula with prebiotics | Other | Experimental 1: Cow milk-based infant formula |
| Experimental 2: Cow milk-based infant formulaExperimental 2: Cow milk-based infant formula with probiotics | Other | Experimental 2: Cow milk-based infant formula |
| Experimental 3: Cow milk-based infant formulaExperimental 3: Cow milk-based infant formula with prebiotics and probiotics | Other | Experimental 3: Cow milk-based infant formula |
Primary outcome
Change in fecal microbiota
Time frame: 3.5 months
6 secondary outcomes
Body Weight measured at each study visit
Time frame: Up to 3.5 months
Body Length measured at each study visit
Time frame: Up to 3.5 months
Head circumference measured at each study visit
Time frame: Up to 3.5 months
Recall of infant formula usage at each study visit
Time frame: Up to 3.5 months
Recall of gastrointestinal tolerance questionnaire at each study visit
Time frame: Up to 3.5 months
Medically-confirmed adverse events collected throughout the study period
Time frame: Up to 3.5 months
Results and safety
The study was stopped early (reason given: Recruitment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
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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.
Steven Wu study director
Mead Johnson Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental 1: Cow milk-based infant formula, Experimental 2: Cow milk-based infant formula and Experimental 3: Cow milk-based infant formula in people with Metabolomics, run by Mead Johnson Nutrition 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 2 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 20 Aug 2018. 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 was stopped early (reason given: Recruitment challenges). 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?
Change in fecal microbiota (time frame: 3.5 months). 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 20 Aug 2018.