Gastrointestinal MicrobiomeNCT04059666
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
A study testing Investigational in people with Gastrointestinal Microbiome, run by Mead Johnson Nutrition at 5 sites in United States.
Trial summary
This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period. Read more about this study
- Who is it for?
- Ages 7 to 18 daysHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Microbiome
- What is being tested?
- Investigational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Mar 2019to 2 Feb 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 7 to 18 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 7-18 days of age at Visit 1
- Singleton birth
- Gestational age of 37-42 weeks
- Birth weight of 2500 g (5 lbs 8 oz) or more
- Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
- Signed informed consent and use of PHI for infant and birth mother
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- Receipt of three protocol-compliant Baseline stool samples
- Infants receiving formula:
- Exclusively receiving infant formula for at least 24 hours prior to randomization
- Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period
- Infants receiving human milk:
- Mother has intention to exclusively provide mother's-own breast milk for the duration of the study
Who cannot join
- Caesarean delivery
- Infant consumption of donor milk prior to randomization/registration
- Maternal antibiotic use within 48 hours prior to or at time of delivery
- Maternal antibiotic use while providing mother's-own breast milk to infant
- Infant use of systemic antibiotics prior to randomization/registration
- Any signs of an acute infection (i.e. fever, diarrhea) at randomization/registration
Show all 14Show fewer
- Weight at Visit 1 is <95% of birth weight
- Infant use of probiotics
- Evidence of significant feeding difficulties
- Infant was born large for gestational age
- History of underlying metabolic or chronic disease or congenital malformation
- Infant is immunocompromised
- Infants receiving human milk:
- Consumption of infant formula from 1 day of age
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Children's Research, LLC
Altamonte Springs, Florida, 32701
Birmingham Pediatric Associates
Birmingham, Alabama, 35205
Holston Medical Group
Kingsport, Tennessee, 37660
Memphis & Shelby County Pediatric
Memphis, Tennessee, 38116
Owensboro Pediatrics
Owensboro, Kentucky, 42303
About this study
This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.
- Conditions
- Gastrointestinal Microbiome
- Being tested
- Investigational, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InvestigationalOther
Cow's milk-based Infant Formula with whey protein-lipid concentrate
ControlOther
Cow's milk-based Infant Formula
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Other: Control |
| Investigational | Experimental | Not described Receives: Other: Investigational |
| Mother's-own Breast Milk | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of stool microbiome between breast fed and formula fed babies
Stool collection
Measured: Over 60 days
Secondary outcomes (6)
Oral microbiome at each visit
Buccal swab
Measured: Over 60 days
Stool molecules at each visit
Stool sample
Measured: Over 60 days
24 hour recall of formula intake
24 hour recall questionnaire
Measured: 2 times over 60 days
Stool color and consistency
Color and consistency
Measured: 3 times over 60 days
Medically confirmed adverse events
Medically confirmed adverse events
Measured: 60 days
Stool pH
pH
Measured: Over 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start5 Mar 2019
- Primary completion2 Feb 2022
- Study completion2 Feb 2022
Why it stopped: Slow enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal MicrobiomeStudies 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059666
- Sponsor's protocol ID
- 3390-1
- Status last verified
- Aug 2022
- First submitted
- 8 May 2019
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christensen C, Kok CR, Harris CL, Moore N, Wampler JL, Zhuang W, Wu SS, Hutkins R, Izard J, Auchtung JM. Microbiota, metabolic profiles and immune biomarkers in infants receiving formula with added bovine milk fat globule membrane: a randomized, controlled trial. Front Nutr. 2024 Oct 4;11:1465174. doi: 10.3389/fnut.2024.1465174. eCollection 2024.
PubMed 39444571
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
- ClinicalTrials.gov ID
- NCT04059666
- Acronym / sponsor ID
- 3390-1
- Conditions
- Gastrointestinal Microbiome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrolment
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 16 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.
This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.
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 |
|---|---|---|
| Control | Active comparator | Other: Control |
| Investigational | Experimental | Other: Investigational |
| Mother's-own Breast Milk | No intervention | – |
Who may qualify
- Ages
- 7 to 18 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 7-18 days of age at Visit 1
- Singleton birth
- Gestational age of 37-42 weeks
- Birth weight of 2500 g (5 lbs 8 oz) or more
- Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
Key exclusion criteria (14 listed)
- Caesarean delivery
- Infant consumption of donor milk prior to randomization/registration
- Maternal antibiotic use within 48 hours prior to or at time of delivery
- Maternal antibiotic use while providing mother's-own breast milk to infant
- Infant use of systemic antibiotics prior to randomization/registration
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 |
|---|---|---|
| InvestigationalCow's milk-based Infant Formula with whey protein-lipid concentrate | Other | Investigational |
| ControlCow's milk-based Infant Formula | Other | Control |
Primary outcome
Comparison of stool microbiome between breast fed and formula fed babies
Time frame: Over 60 days
Stool collection
6 secondary outcomes
Oral microbiome at each visit
Time frame: Over 60 days
Stool molecules at each visit
Time frame: Over 60 days
24 hour recall of formula intake
Time frame: 2 times over 60 days
Stool color and consistency
Time frame: 3 times over 60 days
Medically confirmed adverse events
Time frame: 60 days
Stool pH
Time frame: Over 60 days
Results and safety
The study was stopped early (reason given: Slow enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Derived from this study: PubMed 39444571Christensen C, Kok CR, Harris CL, Moore N, Wampler JL, Zhuang W, Wu SS, Hutkins R, Izard J, Auchtung JM. Microbiota, metabolic profiles and immune biomarkers in infants receiving formula with added bovine milk fat globule membrane: a randomized, controlled trial. Front Nutr. 2024 Oct 4;11:1465174. doi: 10.3389/fnut.2024.1465174. eCollection 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational in people with Gastrointestinal Microbiome, run by Mead Johnson Nutrition at 5 sites 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 12 inclusion and 14 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 25 Aug 2022. 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 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 was stopped early (reason given: Slow enrolment). 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?
Comparison of stool microbiome between breast fed and formula fed babies (time frame: Over 60 days). 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 NCT04059666, 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 25 Aug 2022.