Infant Term BirthNCT03710551
Happy Smooth Study
A study testing Experimental Infant Formula and Standard Infant Formula in people with Infant Term Birth, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
Trial summary
The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula. Read more about this study
- Who is it for?
- Ages 21 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Term Birth
- What is being tested?
- Experimental Infant Formula and Standard Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePhilippines
- Study dates
- 26 Sep 2018to 21 Jul 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 21 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written Informed Consent
- Infants whose parents/LAR have reached the legal age of majority in the Philippines
- Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol
- Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study
- Healthy term, singleton infant at birth
- Between 21 to 28 days post-natal age at enrollment visit
- Weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables/charts
- Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment
Who cannot join
- Infants with conditions requiring infant feedings other than those specified in the protocol
- Infants receiving complementary foods or liquids
- Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
- Infants who are presently receiving or have received medications that could interfere with the interpretation of the study results
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Asian Hospital and Medical Center
City of Muntinlupa, 1781
About this study
Official title: Stool Composition and GI Tolerance in Infants Fed a Term Infant Formula With a New Fat Blend Plus L.Reuteri: a Randomized Controlled Trial
The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.
Read the detailed description
Double-blind, randomized, controlled clinical trial. The purpose of this study is to evaluate the stool composition and GI tolerance of 140 healthy, term infants fed with an infant formula with a new fat blend plus L. reuteri vs a standard infant formula. All enrolled infants will participate in the trial for approximately 71 days.
- Conditions
- Infant Term Birth
- Being tested
- Experimental Infant Formula, Standard Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Infant FormulaOther
Standard bovine milk-based infant formula with a new fat blend plus L. reuteri, fed ad libitum
Standard Infant FormulaOther
Standard bovine milk-based infant formula, fed ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Experimental Infant Formula | Experimental | Experimental Infant Formula with a new fat blend plus L. reuteri Receives: Other: Experimental Infant Formula |
| Standard Infant Formula | Active comparator | Standard bovine milk-based infant formula. Receives: Other: Standard Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Consistency Score
3-day Gastrointestinal (GI) Symptom and Behavior Diary, a parent-reported symptom diary to record stool consistency and stool frequency over the 3 consecutive days.
A validated 5-point pictorial representation of the consistency of the stool for infants ≤1 year (1=watery, 2=runny, 3=mushy soft, 4=formed, 5=hard) will be provided in the stool diary for parent(s)/LAR to visually assess the infants' stools.
Stool consistency will be compared between formula groups The baseline stool consistency value will also be included in the model as a covariate.
the percentage of stools in each category (watery, runny, mushy soft, formed, or hard) will be calculated by visit for each infant and then will be summarized using the appropriate descriptive statistics. Figures composed of a series of histograms will be produced for each 3-day stool diary period.
Measured: Study Day 57, corresponding to infant age of 78-85 days
Secondary outcomes (4)
GI Tolerance
Infant Gastrointestinal Symptom Questionnaire (IGSQ)
Overall GI symptom burden will be measured with the IGSQ-13 questionnaire. The IGSQ-13 is an interviewer-administered questionnaire which measures how well the infant tolerates his/her feedings from the parent's/caregiver's perspective. The questionnaire is composed of 13 questions, categorized into 5 symptom domains of stooling, vomiting/spitting-up, crying, fuzziness, and flatulence and summed to calculate an index score.
Measured: which corresponds to infant age of 21-28, 43-50, and 78-85 days.
Changes in Weight from baseline to 57 days
weight (kg)
Measured: Study Day 57, corresponding to infant age of 78-85 days
Changes in Length from baseline to 57 days
length (cm)
Measured: Study Day 57, corresponding to infant age of 78-85 days
Changes in Head Circumference from baseline to 57 days
head circumference (cm)
Measured: Study Day 57, corresponding to infant age of 78-85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start26 Sep 2018
- Primary completion21 Jun 2019
- Study completion21 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Term BirthStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elvira M Estorninos, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710551
- Sponsor's protocol ID
- 16.28.INF
- Status last verified
- Feb 2021
- First submitted
- 16 Oct 2018
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stool Composition and GI Tolerance in Infants Fed a Term Infant Formula With a New Fat Blend Plus L.Reuteri: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03710551
- Acronym / sponsor ID
- 16.28.INF
- Conditions
- Infant Term Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jul 2019 (actual)
- First posted
- 18 Oct 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.
The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.
Detailed description
Double-blind, randomized, controlled clinical trial. The purpose of this study is to evaluate the stool composition and GI tolerance of 140 healthy, term infants fed with an infant formula with a new fat blend plus L. reuteri vs a standard infant formula. All enrolled infants will participate in the trial for approximately 71 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Infant Formula | Experimental | Other: Experimental Infant FormulaExperimental Infant Formula with a new fat blend plus L. reuteri |
| Standard Infant Formula | Active comparator | Other: Standard Infant FormulaStandard bovine milk-based infant formula. |
Who may qualify
- Ages
- 21 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Written Informed Consent
- Infants whose parents/LAR have reached the legal age of majority in the Philippines
- Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol
- Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study
- Healthy term, singleton infant at birth
Key exclusion criteria (4 listed)
- Infants with conditions requiring infant feedings other than those specified in the protocol
- Infants receiving complementary foods or liquids
- Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
- Infants who are presently receiving or have received medications that could interfere with the interpretation of the study results
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 |
|---|---|---|
| Experimental Infant FormulaStandard bovine milk-based infant formula with a new fat blend plus L. reuteri, fed ad libitum | Other | Experimental Infant Formula |
| Standard Infant FormulaStandard bovine milk-based infant formula, fed ad libitum | Other | Standard Infant Formula |
Primary outcome
Stool Consistency Score
Time frame: Study Day 57, corresponding to infant age of 78-85 days
3-day Gastrointestinal (GI) Symptom and Behavior Diary, a parent-reported symptom diary to record stool consistency and stool frequency over the 3 consecutive days. A validated 5-point pictorial representation of the consistency of the stool for infants ≤1 year (1=watery, 2=runny, 3=mushy soft, 4=formed, 5=hard) will be provided in the stool diary for parent(s)/LAR to visually assess the infants' stools. Stool consistency will be compared between formula groups The baseline stool consistency value will also be included in the model as a covariate. the percentage of stools in each category (watery, runny, mushy soft, formed, or hard) will be calculated by visit for each infant and then will be summarized using the appropriate descriptive statistics. Figures composed of a series of histograms will be produced for each 3-day stool diary period.
4 secondary outcomes
GI Tolerance
Time frame: which corresponds to infant age of 21-28, 43-50, and 78-85 days.
Changes in Weight from baseline to 57 days
Time frame: Study Day 57, corresponding to infant age of 78-85 days
Changes in Length from baseline to 57 days
Time frame: Study Day 57, corresponding to infant age of 78-85 days
Changes in Head Circumference from baseline to 57 days
Time frame: Study Day 57, corresponding to infant age of 78-85 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 21 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Elvira M Estorninos principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Infant Formula and Standard Infant Formula in people with Infant Term Birth, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
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 8 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 21 Feb 2021. 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 Philippines. 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?
Stool Consistency Score (time frame: Study Day 57, corresponding to infant age of 78-85 days). 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 21 Feb 2021; AzTrials last refreshed its copy on 27 Oct 2026.