Healthy, Full-term Infants Who Are Formula-fedNCT03307122
Gastrointestinal Tolerance Evaluation of an Infant Formula
A study testing Routine Infant Formula 1 and Routine Infant Formula 2 in people with Healthy, Full-term Infants Who Are Formula-fed, run by Société des Produits Nestlé (SPN) at 8 sites in United States.
Trial summary
Prospective, double-blind, randomized study of 2 infant formulas. Read more about this study
- Who is it for?
- Ages 9 to 19 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy, Full-term Infants Who Are Formula-fed
- What is being tested?
- Routine Infant Formula 1 and Routine Infant Formula 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 8 sitesUnited States
- Study dates
- 21 Sep 2017to 19 Jan 2018
- 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 9 to 19 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn singleton infant
- Full-term (> 37 weeks gestation)
- Birth weight ≥ 2500 grams and ≤ 4500 grams
- 9-19 days of age on enrollment
- Infant's mother has elected not to breastfeed prior to enrollment and infant has exclusively formula-fed for at least 3days prior to enrollment
- 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. extensively hydrolyzed, amino acid-based, metabolic), or soy-based or lactose free infant formula
- Currently not tolerating (as perceived by the caregiver) their formula
- Currently being treated for reflux
- Currently experiencing gastrointestinal or respiratory symptoms secondary to an on-going infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
- Congenital illness or malformation that may affect infant feeding and/or growth
Show all 10Show fewer
- Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
- Receiving prescription medication (with exception of treatment for thrush or topical medications) or home remedies, herbal preparations, or rehydration fluids that might affect GI tolerance (vitamin and mineral supplements excepted).
- 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Coastal Pediatric Associates
Charleston, South Carolina, 29414
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Tanner Clinic
Layton, Utah, 84041
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291
Midsouth Center for Clinical Research, LLC
Memphis, Tennessee, 38116
PediaResearch
Owensboro, Kentucky, 42310
Avanza Medical Research Center
Pensacola, Florida, 32503
Southwest Children's Research Associates
San Antonio, Texas, 78229
About this study
Official title: Infant Formula GI Tolerance Evaluation
Prospective, double-blind, randomized study of 2 infant formulas.
Read the detailed description
Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.
- Being tested
- Routine Infant Formula 1, Routine Infant Formula 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Infant Formula 1Other
Routine infant formula with probiotic
Routine Infant Formula 2Other
Routine infant formula with probiotic and prebiotic
| Study group | Role | What they receive |
|---|---|---|
| Routine Infant Formula 1 | Active comparator | Routine infant formula with probiotic Receives: Other: Routine Infant Formula 1 |
| Routine Infant Formula 2 | Active comparator | Routine infant formula with probiotic and prebiotic Receives: Other: Routine Infant Formula 2 |
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: 6 weeks
Secondary outcomes (8)
Stool pattern
Caregivers will document on diary records
Measured: 6 weeks
Spit-up and/or vomiting pattern
Caregivers will document on diary records
Measured: 6 weeks
Crying and fussing duration
Caregivers will document on diary records
Measured: 6 weeks
Formula intake
Caregivers will document on diary records
Measured: 6 weeks
Formula satisfaction questionnaire
Study personnel will administer questionnaire
Measured: 6 weeks
Weight (measured in grams)
Study personnel will measure
Measured: Enrollment and 6 weeks
Length (measured in centimeters)
Study personnel will measure
Measured: Enrollment and 6 weeks
Adverse events
Assessed throughout study
Measured: 2 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start21 Sep 2017
- Primary completion19 Jan 2018
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, Full-term Infants Who Are Formula-fedStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 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
- NCT03307122
- Sponsor's protocol ID
- 17.01.US.INF
- Status last verified
- May 2018
- First submitted
- 19 Sep 2017
- Last updated
- 23 May 2018
- 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 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Formula GI Tolerance Evaluation
- ClinicalTrials.gov ID
- NCT03307122
- Acronym / sponsor ID
- 17.01.US.INF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 11 Oct 2017 (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.
Prospective, double-blind, randomized study of 2 infant formulas.
Detailed description
Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Infant Formula 1 | Active comparator | Other: Routine Infant Formula 1Routine infant formula with probiotic |
| Routine Infant Formula 2 | Active comparator | Other: Routine Infant Formula 2Routine infant formula with probiotic and prebiotic |
Who may qualify
- Ages
- 9 to 19 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy newborn singleton infant
- Full-term (> 37 weeks gestation)
- Birth weight ≥ 2500 grams and ≤ 4500 grams
- 9-19 days of age on enrollment
- Infant's mother has elected not to breastfeed prior to enrollment and infant has exclusively formula-fed for at least 3days prior to enrollment
Key exclusion criteria (10 listed)
- Known or suspected cow-milk allergy
- Currently receiving a specialty infant formula (e.g. extensively hydrolyzed, amino acid-based, metabolic), or soy-based or lactose free infant formula
- Currently not tolerating (as perceived by the caregiver) their formula
- Currently being treated for reflux
- Currently experiencing gastrointestinal or respiratory symptoms secondary to an on-going infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
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 Formula 1Routine infant formula with probiotic | Other | Routine Infant Formula 1 |
| Routine Infant Formula 2Routine infant formula with probiotic and prebiotic | Other | Routine Infant Formula 2 |
Primary outcome
Infant GI Symptom Burden
Time frame: 6 weeks
Study personnel will administer questionnaire
8 secondary outcomes
Stool pattern
Time frame: 6 weeks
Spit-up and/or vomiting pattern
Time frame: 6 weeks
Crying and fussing duration
Time frame: 6 weeks
Formula intake
Time frame: 6 weeks
Formula satisfaction questionnaire
Time frame: 6 weeks
Weight (measured in grams)
Time frame: Enrollment and 6 weeks
Length (measured in centimeters)
Time frame: Enrollment and 6 weeks
Adverse events
Time frame: 2 weeks and 6 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 23 May 2018.
- Individual participant dataSharing planned: No
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
8 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 1 and Routine Infant Formula 2 in people with Healthy, Full-term Infants Who Are Formula-fed, run by Société des Produits Nestlé (SPN) at 8 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 6 inclusion and 10 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 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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: 6 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 23 May 2018.