Feeding DisorderNCT02021058
Study in Unsettled Infants Experiencing Feeding Intolerance
A study testing Experimental Formula in people with Feeding Disorder, run by Société des Produits Nestlé (SPN) at 6 sites in 4 countries.
Trial summary
Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance Read more about this study
- Who is it for?
- Ages 30 to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Feeding Disorder
- What is being tested?
- Experimental Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 12 Dec 2013to 23 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 30 to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full term infants, singleton, healthy at birth
- Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
- Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
- Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.
Who cannot join
- Infants who are consuming any amount of supplemental human milk
- Infants who are consuming weaning foods or beverages other than infant formula
- Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
- Infants who have a medical condition or history that could cause or contribute to feeding intolerance
- Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Taiwan3 sites
Chang Gung Memorial Hospital - Linkou
Hsiang, Taoyan Hsien
Mackay Memorial Hospital - Tamsui
New Taipei City
Mackay Memorial Hospital - Taipei
Taipei
Philippines1 site
Asian Hospital and Medical Center
City of Muntinlupa, 1780
Thailand1 site
King Chulalongkorn Memorial Hospital - Faculty of Medicine, Chulalongkorn University
Pratumwan, Bangkok, 10330
About this study
Official title: Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance
Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance
Read the detailed description
The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.
- Conditions
- Feeding Disorder
- Being tested
- Experimental Formula, Standard control formula
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental FormulaOther
Experimental formula
Standard control formulaOther
Standard Infant formula
| Study group | Role | What they receive |
|---|---|---|
| Experimental Formula | Experimental | Experimental Formula Receives: Other: Experimental Formula |
| Standard Formula | Other | Standard Control formula Receives: Other: Standard control formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline to 14 days in fuss-cry behavior
fuss-cry behavior per 24 hours
Measured: from baseline to 14 days
Secondary outcomes (1)
Change from baseline to 14 days in GI symptoms
Measured: from baseline to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study start12 Dec 2013
- Primary completionApr 2016
- Study completion23 Aug 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 Feeding DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Associate Professor Boosba Vivatvakin, MD, Principal investigator, Pediatric Department, Faculty of Medicine, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021058
- Sponsor's protocol ID
- 13.10.INF
- Status last verified
- Sep 2021
- First submitted
- 22 Nov 2013
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vivatvakin B, Estorninos E, Lien R, Lee HC, Hon KLE, Lebumfacil J, Cercamondi CI, Volger S. Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial. Glob Pediatr Health. 2020 Sep 25;7:2333794X20954332. doi: 10.1177/2333794X20954332. eCollection 2020.
PubMed 33029552
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance
- ClinicalTrials.gov ID
- NCT02021058
- Acronym / sponsor ID
- 13.10.INF
- Conditions
- Feeding Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- 23 Aug 2016 (actual)
- First posted
- 27 Dec 2013 (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.
Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance
Detailed description
The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.
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 |
|---|---|---|
| Experimental Formula | Experimental | Other: Experimental FormulaExperimental Formula |
| Standard Formula | Other | Other: Standard control formulaStandard Control formula |
Who may qualify
- Ages
- 30 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Full term infants, singleton, healthy at birth
- Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
- Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
- Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.
Key exclusion criteria (5 listed)
- Infants who are consuming any amount of supplemental human milk
- Infants who are consuming weaning foods or beverages other than infant formula
- Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
- Infants who have a medical condition or history that could cause or contribute to feeding intolerance
- Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment
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 FormulaExperimental formula | Other | Experimental Formula |
| Standard control formulaStandard Infant formula | Other | Standard Formula |
Primary outcome
Changes from baseline to 14 days in fuss-cry behavior
Time frame: from baseline to 14 days
fuss-cry behavior per 24 hours
1 secondary outcome
Change from baseline to 14 days in GI symptoms
Time frame: from baseline to 14 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 17 Sep 2021.
- Derived from this study: PubMed 33029552Vivatvakin B, Estorninos E, Lien R, Lee HC, Hon KLE, Lebumfacil J, Cercamondi CI, Volger S. Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial. Glob Pediatr Health. 2020 Sep 25;7:2333794X20954332. doi: 10.1177/2333794X20954332. eCollection 2020.
- 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.
Associate Professor Boosba Vivatvakin, MD principal investigator
Pediatric Department, Faculty of Medicine, Chulalongkorn University
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Formula in people with Feeding Disorder, run by Société des Produits Nestlé (SPN) at 6 sites in 4 countries.
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 4 inclusion and 5 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 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan, Hong Kong, Philippines, Thailand. 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?
Changes from baseline to 14 days in fuss-cry behavior (time frame: from baseline to 14 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 NCT02021058, 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 17 Sep 2021.