InfantNCT00948051
Effects of follow-on Formula Enriched on Short-chain Fructooligosaccharides (scFOS) on Immune Response in Healthy Infants
A study testing Follow-on formula supplemented with fructo-oligosaccharides in people with Infant, run by Syral at 1 site in Spain.
Trial summary
In this study the investigators hypothesized that the chronic intake of fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus vaccination and bifidobacteria in infants. Read more about this study
- Who is it for?
- Ages 4 to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant
- What is being tested?
- Follow-on formula supplemented with fructo-oligosaccharides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2009to Dec 2010
- 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 4 to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- infants aged of 4 months at randomization
- not breast-fed infants
Who cannot join
- infants suffering from a chronic or severe disease susceptible to interfere with one of the evaluation criteria
- infants suffering from a disease associated with gastro-intestinal disorder
- infants who have taken antibiotic during the 2 months preceding randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled, Double-blind Randomized Study to Evaluate the Efficacy of a follow-on Milk Formula Supplemented With Fructo-oligosaccharides on Immune Response in Healthy Infants
In this study the investigators hypothesized that the chronic intake of fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus vaccination and bifidobacteria in infants.
- Conditions
- Infant
- Being tested
- Follow-on formula supplemented with fructo-oligosaccharides, Follow-on formula enriched with placebo (maltodextrins)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-on formula supplemented with fructo-oligosaccharidesDietary supplement
Follow-on formula supplemented with fructo-oligosaccharides
Follow-on formula enriched with placebo (maltodextrins)Dietary supplement
Follow-on formula enriched with placebo (maltodextrins)
| Study group | Role | What they receive |
|---|---|---|
| Fructo-oligosaccharides | Experimental | Not described Receives: Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination
Measured: 1 month
Secondary outcomes (1)
To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's faecal bifidobacteria concentration
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syral
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948051
- Sponsor's protocol ID
- FOS_FOF08
- Status last verified
- Apr 2011
- First submitted
- 27 Jul 2009
- Last updated
- 13 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Double-blind Randomized Study to Evaluate the Efficacy of a follow-on Milk Formula Supplemented With Fructo-oligosaccharides on Immune Response in Healthy Infants
- ClinicalTrials.gov ID
- NCT00948051
- Acronym / sponsor ID
- FOS_FOF08
- Conditions
- Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SyralIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Jul 2009 (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 investigators hypothesized that the chronic intake of fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus vaccination and bifidobacteria in infants.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fructo-oligosaccharides | Experimental | Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides |
| Placebo | Placebo comparator | Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins) |
Who may qualify
- Ages
- 4 to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- infants aged of 4 months at randomization
- not breast-fed infants
Key exclusion criteria (3 listed)
- infants suffering from a chronic or severe disease susceptible to interfere with one of the evaluation criteria
- infants suffering from a disease associated with gastro-intestinal disorder
- infants who have taken antibiotic during the 2 months preceding randomization
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 |
|---|---|---|
| Follow-on formula supplemented with fructo-oligosaccharidesFollow-on formula supplemented with fructo-oligosaccharides | Dietary supplement | Fructo-oligosaccharides |
| Follow-on formula enriched with placebo (maltodextrins)Follow-on formula enriched with placebo (maltodextrins) | Dietary supplement | Placebo |
Primary outcome
To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination
Time frame: 1 month
1 secondary outcome
To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's faecal bifidobacteria concentration
Time frame: 1 month
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 13 Apr 2011.
Related trials for Infant
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-on formula supplemented with fructo-oligosaccharides in people with Infant, run by Syral at 1 site in Spain.
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 2 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 13 Apr 2011. 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 Spain. 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.
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?
To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination (time frame: 1 month). 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 13 Apr 2011.