Healthy InfantsPhase 3STAR-IFFONCT01515644
Study on the Effect of Inulin in Infant Formula on Gut Health
A Phase 3 study testing Powder based infant formula in people with Healthy Infants, run by PT. Sari Husada at 1 site in Indonesia.
Trial summary
In this study the effect of Infant formula with added Inulin will be compared with the effect of Infant formula without Inulin on the Bifidobacterium level in stool. It is expected that drinking Infant formula with added Inulin will result in higher beneficial bacteria level in stool compared to an Infant formula… Read more about this study
- Who is it for?
- Ages 3 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Powder based infant formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteIndonesia
- Study dates
- Oct 2011to Feb 2013
- Phase
- Phase 3
- 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 3 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants between 3-4 months (91-120 days after birth) of age at day 1 of the study, with healthy growth determined based on WHO standard
- Fully formula-fed in the 28 days prior to inclusion
- Expected investigational product intake of min 500ml per day
- Written informed consent from the parents
Who cannot join
- Low birth weight (LBW) less than 2,000g.
- Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special toddler formula is required)
- Use of systemic antibiotics or antimycotics medication in the 14 days prior to the study
- Significant congenital abnormality that will interfere with the study objectives in the opinion of the investigator.
- Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Not consuming study product longer than 2 days consecutively
- Intake of study product is less than 500ml per day for 7 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Controlled Study on the Effect of Inulin on Gut Health of Infants
In this study the effect of Infant formula with added Inulin will be compared with the effect of Infant formula without Inulin on the Bifidobacterium level in stool.
It is expected that drinking Infant formula with added Inulin will result in higher beneficial bacteria level in stool compared to an Infant formula without Inulin.
- Conditions
- Healthy Infants
- Being tested
- Powder based infant formula
- Keywords
- Healthy infants, Infant formula, Prebiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powder based infant formulaOther
Powder based infant formula with Inulin I
Powder based infant formulaOther
Powder based infant formula with Inulin II
Powder based infant formulaOther
Powder based infant formula without Inulin
| Study group | Role | What they receive |
|---|---|---|
| Intervention group I | Experimental | Intervention group I: Powder based Infant formula with Inulin I Receives: Other: Powder based infant formula |
| Intervention group II | Experimental | Intervention group II: Powder based Infant formula with Inulin II Receives: Other: Powder based infant formula |
| Intervention group III | Placebo comparator | Intervention group III: Powder based Infant formula without Inulin Receives: Other: Powder based infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between beneficial bacteria I level in stool at week 4 and week 8.
Measured: Week 4, Week 8.
Secondary outcomes (6)
Difference between beneficial bacteria II level in stool at week 4 and week 8.
Measured: Week 4, Week 8.
Difference between pH of stool at week 4 and week 8.
Measured: Week 4, Week 8.
Difference between stool consistency at week 4 and week 8.
Measured: Week 4, Week 8.
Difference between sIgA at week 4 and week 8.
Measured: Week 4, Week 8.
Difference between SCFA at week 4 and week 8.
Measured: Week 4, Week 8.
Safety and tolerability.
The safety and tolerability achieved by continuous recording of adverse events, including the occurrence of diarrhea and constipation.
Measured: From date of baseline visit (day 1) until the date of visit 8 (day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionFeb 2013
- Study completionFeb 2013
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT. Sari Husada
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Sponsor
- Investigators
- Hanifah Oswari, dr., Sp.A(K), PhD, Principal investigator, Research Unit of Indonesian Pediatrics Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515644
- Sponsor's protocol ID
- CT.01.2010
- Acronym
- STAR-IFFO
- Status last verified
- Apr 2013
- First submitted
- 5 Jan 2012
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled Study on the Effect of Inulin on Gut Health of Infants
- ClinicalTrials.gov ID
- NCT01515644
- Acronym / sponsor ID
- STAR-IFFO / CT.01.2010
- Conditions
- Healthy Infants
- Keywords
- Healthy infants, Infant formula, Prebiotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- PT. Sari HusadaIndustry (pharma, biotech, devices)
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Jan 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.
In this study the effect of Infant formula with added Inulin will be compared with the effect of Infant formula without Inulin on the Bifidobacterium level in stool.
It is expected that drinking Infant formula with added Inulin will result in higher beneficial bacteria level in stool compared to an Infant formula without Inulin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group I | Experimental | Other: Powder based infant formulaIntervention group I: Powder based Infant formula with Inulin I |
| Intervention group II | Experimental | Other: Powder based infant formulaIntervention group II: Powder based Infant formula with Inulin II |
| Intervention group III | Placebo comparator | Other: Powder based infant formulaIntervention group III: Powder based Infant formula without Inulin |
Who may qualify
- Ages
- 3 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy infants between 3-4 months (91-120 days after birth) of age at day 1 of the study, with healthy growth determined based on WHO standard
- Fully formula-fed in the 28 days prior to inclusion
- Expected investigational product intake of min 500ml per day
- Written informed consent from the parents
Key exclusion criteria (8 listed)
- Low birth weight (LBW) less than 2,000g.
- Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special toddler formula is required)
- Use of systemic antibiotics or antimycotics medication in the 14 days prior to the study
- Significant congenital abnormality that will interfere with the study objectives in the opinion of the investigator.
- Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
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 |
|---|---|---|
| Powder based infant formulaPowder based infant formula with Inulin I | Other | Intervention group I |
| Powder based infant formulaPowder based infant formula with Inulin II | Other | Intervention group II |
| Powder based infant formulaPowder based infant formula without Inulin | Other | Intervention group III |
Primary outcome
Difference between beneficial bacteria I level in stool at week 4 and week 8.
Time frame: Week 4, Week 8.
6 secondary outcomes
Difference between beneficial bacteria II level in stool at week 4 and week 8.
Time frame: Week 4, Week 8.
Difference between pH of stool at week 4 and week 8.
Time frame: Week 4, Week 8.
Difference between stool consistency at week 4 and week 8.
Time frame: Week 4, Week 8.
Difference between sIgA at week 4 and week 8.
Time frame: Week 4, Week 8.
Difference between SCFA at week 4 and week 8.
Time frame: Week 4, Week 8.
Safety and tolerability.
Time frame: From date of baseline visit (day 1) until the date of visit 8 (day 56)
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 24 Apr 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.
Hanifah Oswari, dr., Sp.A(K), PhD principal investigator
Research Unit of Indonesian Pediatrics Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Powder based infant formula in people with Healthy Infants, run by PT. Sari Husada at 1 site in Indonesia.
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 8 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 24 Apr 2013. 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference between beneficial bacteria I level in stool at week 4 and week 8. (time frame: Week 4, Week 8.). 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 24 Apr 2013.