Healthy InfantsNCT03679234
Impact of Infant Formula on Caregiver-perceived Intolerance
A study testing Routine infant formula in people with Healthy Infants, run by Société des Produits Nestlé (SPN) at 7 sites in United States.
Trial summary
Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms Read more about this study
- Who is it for?
- Ages 14 to 60 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Routine infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Sep 2018to 1 Apr 2019
- 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 60 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infant
- Full-term (> 37 weeks gestation)
- Birth weight > 2500 and < 4500 g
- 14-60 days of age on enrollment
- Singleton birth
- Infant's mother has elected not to breastfeed prior to enrollment
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- Infant exclusively formula-fed for at least 5 days prior to enrollment
- Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days
- Caregiver wishes to switch infant's formula
- Has not received solid foods
- Having obtained his/her legal representative's informed consent
Who cannot join
- Known or suspected cow-milk allergy
- Currently receiving a specialty infant formula (e.g. thickened, extensively hydrolyzed, amino acid-based, metabolic)
- Has switched formula more than two times since hospital discharge
- Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
- Congenital illness or malformation that may affect infant feeding and/or growth
- Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
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- Receiving probiotic supplements
- Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen).
- Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Coastal Pediatric Associates
Charleston, South Carolina, 29414
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Tanner Clinic
Layton, Utah, 84041
Midsouth Center for Clinical Research, LLC
Memphis, Tennessee, 38116
Norwich Pediatrics Group
Norwich, Connecticut, 06360
Qualmedica Research
Owensboro, Kentucky, 42301
ClinPoint Trials
Waxahachie, Texas, 75165
About this study
Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms
- Conditions
- Healthy Infants
- Being tested
- Routine infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine infant formulaOther
Routine infant formula with probiotic
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Routine infant formula Receives: Other: Routine infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant GI Symptom Burden
Study personnel will administer questionnaire
Measured: 3 weeks
Secondary outcomes (4)
Formula Intake
Caregivers will document on diary records
Measured: 24 hours
Fussiness
Caregivers will document on diary records
Measured: 24 hours
Formula Satisfaction Questionnaire
Study personnel will administer questionnaire
Measured: 3 weeks
Adverse Events
Assessed throughout study
Measured: 24 hours and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start24 Sep 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Carvalho, MD, Study director, Nestle Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679234
- Sponsor's protocol ID
- 18.01.US.INF
- Status last verified
- Jun 2020
- First submitted
- 19 Sep 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Infant Formula on Caregiver-perceived Intolerance
- ClinicalTrials.gov ID
- NCT03679234
- Acronym / sponsor ID
- 18.01.US.INF
- Conditions
- Healthy Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 20 Sep 2018 (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.
Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Routine infant formulaRoutine infant formula |
Who may qualify
- Ages
- 14 to 60 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Healthy infant
- Full-term (> 37 weeks gestation)
- Birth weight > 2500 and < 4500 g
- 14-60 days of age on enrollment
- Singleton birth
Key exclusion criteria (9 listed)
- Known or suspected cow-milk allergy
- Currently receiving a specialty infant formula (e.g. thickened, extensively hydrolyzed, amino acid-based, metabolic)
- Has switched formula more than two times since hospital discharge
- Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
- Congenital illness or malformation that may affect infant feeding and/or growth
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 |
|---|---|---|
| Routine infant formulaRoutine infant formula with probiotic | Other | Intervention |
Primary outcome
Infant GI Symptom Burden
Time frame: 3 weeks
Study personnel will administer questionnaire
4 secondary outcomes
Formula Intake
Time frame: 24 hours
Fussiness
Time frame: 24 hours
Formula Satisfaction Questionnaire
Time frame: 3 weeks
Adverse Events
Time frame: 24 hours and 3 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 9 Jun 2020.
- 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.
Ryan Carvalho, MD study director
Nestle 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 Routine infant formula in people with Healthy Infants, run by Société des Produits Nestlé (SPN) 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 11 inclusion and 9 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 9 Jun 2020. 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?
Infant GI Symptom Burden (time frame: 3 weeks). 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 9 Jun 2020.