Infant Formula IntoleranceNCT02431377
Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula
A study testing S-26 Gold in people with Infant Formula Intolerance, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
Trial summary
A single center, non-controlled trial to document the gastrointestinal (GI) tolerability of the study formula (SF), containing a whey protein concentrate enriched with alpha-lactalbumin (WPC alpha-lac) fed for 6 weeks to healthy, term infants. Read more about this study
- Who is it for?
- Ages 21 to 35 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Formula Intolerance
- What is being tested?
- S-26 Gold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePhilippines
- Study dates
- Apr 2015to Oct 2015
- 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 35 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent
- Healthy, full term, singleton infant
- Be between 28±7 days post-natal age
- Infants at enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts
- Infants must be exclusively consuming and tolerating a cow's milk infant formula for a minimum of 3 consecutive days and parent(s)/LAR must have previously made the decision to continue to exclusively formula feed
- Have sufficient command of Tagalog or English language to complete the informed consent and other study documents
Show all 9Show fewer
- Are willing and able to fulfill the requirements of the study protocol
- Have reached the legal age of consent in the Philippines
- Able to be contacted by telephone throughout the study
Who cannot join
- Infants who are receiving any amount of supplemental human milk
- Family history of siblings with documented cow's milk protein intolerance/allergy
- Conditions requiring infant feedings other than those specified in the protocol
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Asian Hospital and Medical Center
Alabang, Muntinlupa City, 1780
About this study
Official title: Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula: An Uncontrolled, Open-label, Descriptive Study
A single center, non-controlled trial to document the gastrointestinal (GI) tolerability of the study formula (SF), containing a whey protein concentrate enriched with alpha-lactalbumin (WPC alpha-lac) fed for 6 weeks to healthy, term infants.
Read the detailed description
The purpose of this study is to examine the tolerable and acceptability of an infant formula with with a Whey protein concentrate containing alpha-lactalbumin as measure by GI tolerance, and eating behaviors.
- Conditions
- Infant Formula Intolerance
- Being tested
- S-26 Gold
- Keywords
- infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-26 GoldOther
A commercial whey protein dominant, first age formula, containing whey protein concentrate with alpha-lactalbumin
| Study group | Role | What they receive |
|---|---|---|
| S-26 Gold | Experimental | Standard Infant Formula containing enriched with alpha-lactalbumin Receives: Other: S-26 Gold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Gastrointestinal Symptom Questionnaire Composite Index Score
Measured: 6 weeks
Secondary outcomes (5)
Formula Intake volume
Measured: 6 weeks
Stool Consistency Score
Measured: 6 weeks
Infant Toddler Quality of Life Profile
Measured: 6 weeks
Baby Eating Behaviour Questionnaire Profile
Measured: 6 weeks
Infant Characteristics Questionnaire (ICQ) Profile
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionOct 2015
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 Infant Formula IntoleranceStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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, MD, Principal investigator, Asian Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431377
- Sponsor's protocol ID
- 14.23.INF
- Status last verified
- Oct 2015
- First submitted
- 7 Apr 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Volger S, Estorninos EM, Capeding MR, Lebumfacil J, Radler DR, Scott Parrott J, Rothpletz-Puglia P. Health-related quality of life, temperament, and eating behavior among formula-fed infants in the Philippines: a pilot study. Health Qual Life Outcomes. 2018 Jun 8;16(1):121. doi: 10.1186/s12955-018-0944-5.
PubMed 29884187
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula: An Uncontrolled, Open-label, Descriptive Study
- ClinicalTrials.gov ID
- NCT02431377
- Acronym / sponsor ID
- 14.23.INF
- Conditions
- Infant Formula Intolerance
- Keywords
- infant formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 May 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.
A single center, non-controlled trial to document the gastrointestinal (GI) tolerability of the study formula (SF), containing a whey protein concentrate enriched with alpha-lactalbumin (WPC alpha-lac) fed for 6 weeks to healthy, term infants.
Detailed description
The purpose of this study is to examine the tolerable and acceptability of an infant formula with with a Whey protein concentrate containing alpha-lactalbumin as measure by GI tolerance, and eating behaviors.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-26 Gold | Experimental | Other: S-26 GoldStandard Infant Formula containing enriched with alpha-lactalbumin |
Who may qualify
- Ages
- 21 to 35 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Written informed consent
- Healthy, full term, singleton infant
- Be between 28±7 days post-natal age
- Infants at enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts
- Infants must be exclusively consuming and tolerating a cow's milk infant formula for a minimum of 3 consecutive days and parent(s)/LAR must have previously made the decision to continue to exclusively formula feed
Key exclusion criteria (3 listed)
- Infants who are receiving any amount of supplemental human milk
- Family history of siblings with documented cow's milk protein intolerance/allergy
- Conditions requiring infant feedings other than those specified in the protocol
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 |
|---|---|---|
| S-26 GoldA commercial whey protein dominant, first age formula, containing whey protein concentrate with alpha-lactalbumin | Other | S-26 Gold |
Primary outcome
Infant Gastrointestinal Symptom Questionnaire Composite Index Score
Time frame: 6 weeks
5 secondary outcomes
Formula Intake volume
Time frame: 6 weeks
Stool Consistency Score
Time frame: 6 weeks
Infant Toddler Quality of Life Profile
Time frame: 6 weeks
Baby Eating Behaviour Questionnaire Profile
Time frame: 6 weeks
Infant Characteristics Questionnaire (ICQ) Profile
Time frame: 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 3 Nov 2015.
- Derived from this study: PubMed 29884187Volger S, Estorninos EM, Capeding MR, Lebumfacil J, Radler DR, Scott Parrott J, Rothpletz-Puglia P. Health-related quality of life, temperament, and eating behavior among formula-fed infants in the Philippines: a pilot study. Health Qual Life Outcomes. 2018 Jun 8;16(1):121. doi: 10.1186/s12955-018-0944-5.
Related trials for Infant Formula Intolerance
Not yet recruiting
Partially Hydrolyzed Whey Protein Formula for Infants With Mild Allergy
Mild Allergic Symptoms in Infants, Infant Feeding Intolerance
Not yet recruitingObservational study
Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula
Cow's Milk Protein Allergy Protein Intolerance Failure to Thrive
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, MD principal investigator
Asian Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-26 Gold in people with Infant Formula Intolerance, 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 9 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 3 Nov 2015. 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?
Infant Gastrointestinal Symptom Questionnaire Composite Index Score (time frame: 6 weeks). 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 NCT02431377, 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 3 Nov 2015.