Behavioral Measures of ToleranceNCT02118935
Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance
A study testing Previously marketed cow's mlik-based infant formula and Marketed cow's milk-based infant formula with prebiotics in people with Behavioral Measures of Tolerance, run by Mead Johnson Nutrition at 7 sites in United States.
Trial summary
The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics. Read more about this study
- Who is it for?
- Ages 14 to 35 daysHealthy volunteers can take part
- Conditions the study is for
- Behavioral Measures of Tolerance
- What is being tested?
- Previously marketed cow's mlik-based infant formula and Marketed cow's milk-based infant formula with prebiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2014to Mar 2016
- 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 14 to 35 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton, 14-35 days of age at baseline
- Term infant with birth weight of a minimum of 2500 grams
- Solely formula-fed
- Signed Informed Consent and Protected Health Information authorization
Who cannot join
- History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- Feeding difficulties or formula intolerance
- Maternal history of illicit drug use or psychiatric disease
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Pediatric Associates of Mt. Carmel
Cincinnati, Ohio, 45245
Deaconess Clinic
Evansville, Indiana, 47725
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, 72703
The Jackson Clinic
Jackson, Tennessee, 38305
Universty of Kansas Medical Center
Kansas City, Kansas, 66160
Norwich Pediatrics
Norwich, Connecticut, 06360
Woburn Pediatrics
Woburn, Massachusetts, 01801
About this study
The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.
- Conditions
- Behavioral Measures of Tolerance
- Being tested
- Previously marketed cow's mlik-based infant formula, Marketed cow's milk-based infant formula with prebiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previously marketed cow's mlik-based infant formulaOther
Marketed cow's milk-based infant formula with prebioticsOther
| Study group | Role | What they receive |
|---|---|---|
| Previously marketed cow's milk-based infant formula | Active comparator | Not described Receives: Other: Previously marketed cow's mlik-based infant formula |
| Marketed cow's milk-based infant formula with prebiotics | Experimental | Not described Receives: Other: Marketed cow's milk-based infant formula with prebiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Measures (Amount of time awake and asleep in a 72 hour period)
Measured: 14 weeks
Infant State (Infant behavior over a 72 hour period)
Measured: 14 weeks
Secondary outcomes (9)
Achieved Weight
Total weight gain
Measured: 14 weeks
Achieved Length
Total length gain
Measured: 14 weeks
Achieved Head Circumference
Total head circumference gain
Measured: 14 weeks
Formula Intake
Measured: 14 weeks
Fecal microbiome
Measured: Baseline and 112 days of age
Medically-confirmed Adverse Events
Measured: 14 weeks
Salivary Cortisol levels
Measured: 70 and 120 days of age
Temperament - Infant Behavior Questionnaire
Measured: Once at 112 days of age
Sleep Characteristics
Amount of waking and sleeping, number of waking and sleep episodes
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral Measures of ToleranceStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Kansas Medical Center
- Responsible party
- Sponsor
- Investigators
- Carol Lynn Berseth, MD, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118935
- Sponsor's protocol ID
- 6023
- Status last verified
- Jun 2016
- First submitted
- 4 Apr 2014
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance
- ClinicalTrials.gov ID
- NCT02118935
- Acronym / sponsor ID
- 6023
- Conditions
- Behavioral Measures of Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- University of Kansas Medical Center
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Apr 2014 (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 measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously marketed cow's milk-based infant formula | Active comparator | Other: Previously marketed cow's mlik-based infant formula |
| Marketed cow's milk-based infant formula with prebiotics | Experimental | Other: Marketed cow's milk-based infant formula with prebiotics |
Who may qualify
- Ages
- 14 to 35 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Singleton, 14-35 days of age at baseline
- Term infant with birth weight of a minimum of 2500 grams
- Solely formula-fed
- Signed Informed Consent and Protected Health Information authorization
Key exclusion criteria (3 listed)
- History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- Feeding difficulties or formula intolerance
- Maternal history of illicit drug use or psychiatric disease
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 |
|---|---|---|
| Previously marketed cow's mlik-based infant formula | Other | Previously marketed cow's milk-based infant formula |
| Marketed cow's milk-based infant formula with prebiotics | Other | Marketed cow's milk-based infant formula with prebiotics |
Primary outcome
Sleep Measures (Amount of time awake and asleep in a 72 hour period)
Time frame: 14 weeks
Infant State (Infant behavior over a 72 hour period)
Time frame: 14 weeks
9 secondary outcomes
Achieved Weight
Time frame: 14 weeks
Achieved Length
Time frame: 14 weeks
Achieved Head Circumference
Time frame: 14 weeks
Formula Intake
Time frame: 14 weeks
Fecal microbiome
Time frame: Baseline and 112 days of age
Medically-confirmed Adverse Events
Time frame: 14 weeks
Salivary Cortisol levels
Time frame: 70 and 120 days of age
Temperament - Infant Behavior Questionnaire
Time frame: Once at 112 days of age
Sleep Characteristics
Time frame: 14 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 24 Jun 2016.
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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.
Carol Lynn Berseth, MD study director
Mead Johnson Nutrition
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Previously marketed cow's mlik-based infant formula and Marketed cow's milk-based infant formula with prebiotics in people with Behavioral Measures of Tolerance, run by Mead Johnson Nutrition at 7 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 4 inclusion and 3 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 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
Sleep Measures (Amount of time awake and asleep in a 72 hour period) (time frame: 14 weeks). The study lists 2 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 24 Jun 2016.