Fecal MicrobiotaNCT02500563
Exploratory/Proof of Principle Microbiota Study
A study testing Amino acid based infant formula, Extensively hydrolyzed casein infant formula and Mother's own breast milk in people with Fecal Microbiota, run by Mead Johnson Nutrition at 1 site in United States.
Trial summary
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life. Read more about this study
- Who is it for?
- Ages 1 day to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Fecal Microbiota
- What is being tested?
- Amino acid based infant formula, Extensively hydrolyzed casein infant formula and Mother's own breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 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 1 day to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton, 1-7 days of age at registration or randomization
- Term infant with appropriate birth weight for gestational age
- Either solely formula fed or exclusively receiving mother's own breast milk
- Signed Informed Consent and Protected Health Information
Who cannot join
- Caesarean delivery
- Infant was born from a mother with Type 1 diabetes
- History of underlying metabolic or chronic disease or immunocompromised
- Feeding difficulties or history of formula or human milk intolerance
- Signs of acute infection of current use of antibiotics
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwest Children's Health Research Institue
Lincoln, Nebraska, 68504
About this study
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.
Read the detailed description
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.
- Conditions
- Fecal Microbiota
- Being tested
- Amino acid based infant formula, Extensively hydrolyzed casein infant formula, Mother's own breast milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acid based infant formulaOther
Extensively hydrolyzed casein infant formulaOther
Mother's own breast milkOther
| Study group | Role | What they receive |
|---|---|---|
| Amino acid based infant formula | Active comparator | Not described Receives: Other: Amino acid based infant formula |
| Extensively hydrolyzed casein infant formula | Experimental | Not described Receives: Other: Extensively hydrolyzed casein infant formula |
| Mother's own breast milk | Other | Not described Receives: Other: Mother's own breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiota measured at each visit
Sequencing and composition of samples
Measured: 8 weeks
Secondary outcomes (6)
Body weight measured at each visit
Measurement collected with a calibrated infant scale
Measured: 8 weeks
Body length measured at each visit
Measurement collected with a standardized length board
Measured: 8 weeks
Head circumference measured at each visit
Measurement collected with a standardized measuring tape
Measured: 8 weeks
Parental recall of formula intake at each visit
Measured: 8 weeks
Stool collection at each visit
Composite measure of pH and short chain fatty acids
Measured: 8 weeks
Serious adverse events collected throughout the study period
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fecal MicrobiotaStudies 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Midwest Children's Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Jon Vanderhoof, M.D., Study director, Mead Johnson and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500563
- Sponsor's protocol ID
- 6032
- Status last verified
- Jul 2017
- First submitted
- 15 Jul 2015
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kok CR, Brabec B, Chichlowski M, Harris CL, Moore N, Wampler JL, Vanderhoof J, Rose D, Hutkins R. Stool microbiome, pH and short/branched chain fatty acids in infants receiving extensively hydrolyzed formula, amino acid formula, or human milk through two months of age. BMC Microbiol. 2020 Nov 9;20(1):337. doi: 10.1186/s12866-020-01991-5.
PubMed 33167908Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PubMed 33006765
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory/Proof of Principle Microbiota Study
- ClinicalTrials.gov ID
- NCT02500563
- Acronym / sponsor ID
- 6032
- Conditions
- Fecal Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Midwest Children's Health Research Institute
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 Jul 2015 (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.
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.
Detailed description
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amino acid based infant formula | Active comparator | Other: Amino acid based infant formula |
| Extensively hydrolyzed casein infant formula | Experimental | Other: Extensively hydrolyzed casein infant formula |
| Mother's own breast milk | Other | Other: Mother's own breast milk |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Singleton, 1-7 days of age at registration or randomization
- Term infant with appropriate birth weight for gestational age
- Either solely formula fed or exclusively receiving mother's own breast milk
- Signed Informed Consent and Protected Health Information
Key exclusion criteria (5 listed)
- Caesarean delivery
- Infant was born from a mother with Type 1 diabetes
- History of underlying metabolic or chronic disease or immunocompromised
- Feeding difficulties or history of formula or human milk intolerance
- Signs of acute infection of current use of antibiotics
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 |
|---|---|---|
| Amino acid based infant formula | Other | Amino acid based infant formula |
| Extensively hydrolyzed casein infant formula | Other | Extensively hydrolyzed casein infant formula |
| Mother's own breast milk | Other | Mother's own breast milk |
Primary outcome
Fecal microbiota measured at each visit
Time frame: 8 weeks
Sequencing and composition of samples
6 secondary outcomes
Body weight measured at each visit
Time frame: 8 weeks
Body length measured at each visit
Time frame: 8 weeks
Head circumference measured at each visit
Time frame: 8 weeks
Parental recall of formula intake at each visit
Time frame: 8 weeks
Stool collection at each visit
Time frame: 8 weeks
Serious adverse events collected throughout the study period
Time frame: 8 weeks
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 28 Jul 2017.
- Derived from this study: PubMed 33167908Kok CR, Brabec B, Chichlowski M, Harris CL, Moore N, Wampler JL, Vanderhoof J, Rose D, Hutkins R. Stool microbiome, pH and short/branched chain fatty acids in infants receiving extensively hydrolyzed formula, amino acid formula, or human milk through two months of age. BMC Microbiol. 2020 Nov 9;20(1):337. doi: 10.1186/s12866-020-01991-5.
- Derived from this study: PubMed 33006765Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
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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.
Jon Vanderhoof, M.D. study director
Mead Johnson and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino acid based infant formula, Extensively hydrolyzed casein infant formula and Mother's own breast milk in people with Fecal Microbiota, run by Mead Johnson Nutrition 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 4 inclusion and 5 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 28 Jul 2017. 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. 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?
Fecal microbiota measured at each visit (time frame: 8 weeks). 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 NCT02500563, which also lists 2 linked publications.
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 Jul 2017.