Healthy InfantsBOOGIENCT01681355
Gastrointestinal Tolerance Study of a New Infant Formula
A study testing Infant Formula in people with Healthy Infants, run by Danone Asia Pacific Holdings Pte, Ltd. at 5 sites in 2 countries.
Trial summary
This study is initiated to investigate the gastrointestinal tolerance of a new infant formula in healthy, term, Asian infants. Read more about this study
- Who is it for?
- Ages Up to 17 weeksHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2012to Dec 2012
- 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 Up to 17 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, well-nourished, term, Asian infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks)
- The mother had unequivocally decided not to exclusively breast-feed
- Formula fed for at least one week, receiving at least two formula feedings per day
- Birth weight appropriate for gestational age (AGA), 2500-4000g
- Written informed consent from parent(s) and/or legal guardian, aged ≥ 18 years.
Who cannot join
- Age > 17 weeks
- Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study (impacting tolerance and/or growth), such as gastrointestinal malformations, chronic diarrhoea, malabsorptive syndrome, malnutrition, congenital immunodeficiency, or major surgery, as per investigator's clinical judgement
- Infants who suffered from gastroenteritis or diarrhoea in the last 4 weeks preceding study start.
- Infants who used any medication or nutritional supplements (except for vitamin supplementation to complement breastfeeding) in the 4 weeks preceding study start.
- Infants who have medical conditions for which a special diet other than standard (non hydrolysed) cow's milk-based infant formula is required (such as cow's milk allergy, soy protein allergy, fish protein allergy, egg protein allergy, lactose intolerance, galactosemia).
- Infants with any history of or current participation in any other study involving investigational or marketed products.
- Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Thailand3 sites
King Chulalongkorn Memorial Hospital
Bangkok
Prince of Songkhla University Hospital
Hat Yai
Khon Kaen University Hospital
Khon Kaen
Indonesia2 sites
Panembahan Senopati Distric Hospital
Bantul, DIY Yogyakarta
Sakina Idaman Mothers and Children Hospital
Yogyakarta, DIY Yogyakarta
About this study
Official title: Open-label Study to Evaluate the Gastrointestinal Tolerance of a New Infant Formula in Healthy, Term, Asian Infants
This study is initiated to investigate the gastrointestinal tolerance of a new infant formula in healthy, term, Asian infants.
- Conditions
- Healthy Infants
- Being tested
- Infant Formula
- Keywords
- Healthy, term, Asian infants, Infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant FormulaOther
Standard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Healthy infants receiving standard cow's milk-based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition. Receives: Other: Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance
Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms.
Measured: up to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
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.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan van der Mooren, PhD, Study director, Danone Global Research & Innovation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681355
- Sponsor's protocol ID
- BLU.1.C/A
- Acronym
- BOOGIE
- Status last verified
- Jan 2013
- First submitted
- 5 Sep 2012
- Last updated
- 9 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study to Evaluate the Gastrointestinal Tolerance of a New Infant Formula in Healthy, Term, Asian Infants
- ClinicalTrials.gov ID
- NCT01681355
- Acronym / sponsor ID
- BOOGIE / BLU.1.C/A
- Conditions
- Healthy Infants
- Keywords
- Healthy, term, Asian infants, Infant formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Sep 2012 (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.
This study is initiated to investigate the gastrointestinal tolerance of a new infant formula in healthy, term, Asian infants.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Infant FormulaHealthy infants receiving standard cow's milk-based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition. |
Who may qualify
- Ages
- Up to 17 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy, well-nourished, term, Asian infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks)
- The mother had unequivocally decided not to exclusively breast-feed
- Formula fed for at least one week, receiving at least two formula feedings per day
- Birth weight appropriate for gestational age (AGA), 2500-4000g
- Written informed consent from parent(s) and/or legal guardian, aged ≥ 18 years.
Key exclusion criteria (7 listed)
- Age > 17 weeks
- Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study (impacting tolerance and/or growth), such as gastrointestinal malformations, chronic diarrhoea, malabsorptive syndrome, malnutrition, congenital immunodeficiency, or major surgery, as per investigator's clinical judgement
- Infants who suffered from gastroenteritis or diarrhoea in the last 4 weeks preceding study start.
- Infants who used any medication or nutritional supplements (except for vitamin supplementation to complement breastfeeding) in the 4 weeks preceding study start.
- Infants who have medical conditions for which a special diet other than standard (non hydrolysed) cow's milk-based infant formula is required (such as cow's milk allergy, soy protein allergy, fish protein allergy, egg protein allergy, lactose intolerance, galactosemia).
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 |
|---|---|---|
| Infant FormulaStandard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition | Other | Intervention group |
Primary outcome
Gastrointestinal tolerance
Time frame: up to Week 6
Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms.
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 Jan 2013.
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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.
Jan van der Mooren, PhD study director
Danone Global Research & Innovation Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula in people with Healthy Infants, run by Danone Asia Pacific Holdings Pte, Ltd. at 5 sites in 2 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 5 inclusion and 7 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 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Thailand, Indonesia. 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?
Gastrointestinal tolerance (time frame: up to Week 6). 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 Jan 2013.