ToleranceNCT02340143
Assessing Early Behavioral Indicators of Formula Tolerance
A study testing Investigational in people with Tolerance, run by Mead Johnson Nutrition at 1 site in United States.
Trial summary
The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics. Read more about this study
- Who is it for?
- Ages 14 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Tolerance
- What is being tested?
- Investigational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 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 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton at birth
- Term infant with birth weight of 2500 g or more
- Crying or fussing for 3 or more hours per day
- Consuming mostly infant formula
- Signed Informed Consent and Protected Health Information authorization
Who cannot join
- Current use of extensively hydrolyzed or amino acid infant formula
- Planned use of probiotics during the study
- History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- Enrollment in another interventional clinical research study
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Nutrition Research Center
Houston, Texas, 77030
About this study
The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.
- Conditions
- Tolerance
- Being tested
- Control, Investigational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Marketed partially hydrolyzed cow's milk protein infant formula
InvestigationalOther
Partially hydrolyzed cow's milk protein infant formula with a probiotic
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Marketed partially hydrolyzed cow's milk protein infant formula Receives: Other: Control |
| Investigational | Experimental | Partially hydrolyzed cow's milk infant formula with a probiotic Receives: Other: Investigational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Behavior Diary
Measured: 21 Days
Secondary outcomes (6)
Recall of Tolerance Questionnaire
Measured: Baseline and Day 21
Body Weight
Measured: Baseline and Day 21
Infant Behavior Questionnaire - Revised
Measured: Baseline and Day 21
Recall of formula intake at each visit
Measured: Baseline, Day 10, and Day 18
Fecal microbiome and Fecal calprotectin
Measured: Baseline and Day 21
Medically-confirmed Adverse Events
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionAug 2016
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Carol Lynn Berseth, M.D., Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340143
- Sponsor's protocol ID
- 6025
- Status last verified
- Sep 2016
- First submitted
- 6 Jan 2015
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Shulman RJ, Chichlowski M, Orozco FG, Harris CL, Wampler JL, Bokulich NA, Berseth CL. Infant behavioral state and stool microbiome in infants receiving Lactocaseibacillus rhamnosus GG in formula: randomized controlled trial. BMC Pediatr. 2022 Oct 7;22(1):580. doi: 10.1186/s12887-022-03647-x.
PubMed 36207675
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Early Behavioral Indicators of Formula Tolerance
- ClinicalTrials.gov ID
- NCT02340143
- Acronym / sponsor ID
- 6025
- Conditions
- Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Jan 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.
The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlMarketed partially hydrolyzed cow's milk protein infant formula |
| Investigational | Experimental | Other: InvestigationalPartially hydrolyzed cow's milk infant formula with a probiotic |
Who may qualify
- Ages
- 14 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Singleton at birth
- Term infant with birth weight of 2500 g or more
- Crying or fussing for 3 or more hours per day
- Consuming mostly infant formula
- Signed Informed Consent and Protected Health Information authorization
Key exclusion criteria (4 listed)
- Current use of extensively hydrolyzed or amino acid infant formula
- Planned use of probiotics during the study
- History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- Enrollment in another interventional clinical research study
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 |
|---|---|---|
| ControlMarketed partially hydrolyzed cow's milk protein infant formula | Other | Control |
| InvestigationalPartially hydrolyzed cow's milk protein infant formula with a probiotic | Other | Investigational |
Primary outcome
Infant Behavior Diary
Time frame: 21 Days
6 secondary outcomes
Recall of Tolerance Questionnaire
Time frame: Baseline and Day 21
Body Weight
Time frame: Baseline and Day 21
Infant Behavior Questionnaire - Revised
Time frame: Baseline and Day 21
Recall of formula intake at each visit
Time frame: Baseline, Day 10, and Day 18
Fecal microbiome and Fecal calprotectin
Time frame: Baseline and Day 21
Medically-confirmed Adverse Events
Time frame: 21 Days
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 14 Sep 2016.
- Derived from this study: PubMed 36207675Shulman RJ, Chichlowski M, Orozco FG, Harris CL, Wampler JL, Bokulich NA, Berseth CL. Infant behavioral state and stool microbiome in infants receiving Lactocaseibacillus rhamnosus GG in formula: randomized controlled trial. BMC Pediatr. 2022 Oct 7;22(1):580. doi: 10.1186/s12887-022-03647-x.
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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, M.D. 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 Investigational in people with Tolerance, 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 5 inclusion and 4 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 14 Sep 2016. 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?
Infant Behavior Diary (time frame: 21 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 NCT02340143, 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 14 Sep 2016.