InfectionPhase 1P010NCT00724204
Safety Assessment of Lactobacillus Salivarius CECT5713 in 6 Months Old Children
A Phase 1 study testing follow on formula without probiotics and follow on formula with Lactobacillus salivarius CECT5713 in people with Infection, run by Puleva Biotech at 1 site in Spain.
Trial summary
The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out. Eighty six months old children were recruited by the department of pediatrics of Hospital Univeristario San Cecilio. Read more about this study
- Who is it for?
- Ages 6 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- follow on formula without probiotics and follow on formula with Lactobacillus salivarius CECT5713
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2006to Dec 2007
- Phase
- Phase 1
- 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 6 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy six months old children
Who cannot join
- Lactose intolerance
- Cow's milk protein allergy
- Serious metabolic diseases
- Antibiotic treatment
- Serious gastrointestinal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Evaluation of a Follow on Formula Supplemented With Lactobacillus Salivarius CECT5713
The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out. Eighty six months old children were recruited by the department of pediatrics of Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a follow on formula supplemented or not with the probiotic strain during 6 months. Fecal samples were obtained at the recruitment, at 3 months and at the end of the trial. In addition revision by the pediatrician was performed once a month and possible adverse effects were recorded both by the pediatrician and by parents.
- Conditions
- Infection
- Being tested
- follow on formula without probiotics, follow on formula with Lactobacillus salivarius CECT5713
- Keywords
- probiotics, safety, fecal microbiota, infections
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow on formula without probioticsDietary supplement
A follow on formula without probiotics
follow on formula with Lactobacillus salivarius CECT5713Dietary supplement
follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Children that consumed a follow on formula without Lactobacillus salivarius CECT5713 Receives: Dietary Supplement: follow on formula without probiotics |
| B | Active comparator | Children that consumed a follow on formula with Lactobacillus salivarius CECT5713 Receives: Dietary Supplement: follow on formula with Lactobacillus salivarius CECT5713 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reactions
Measured: 3 months and 6 months
Secondary outcomes (3)
growth parameters (height, length, head circumference)
Measured: 3 months and 6 months
Fecal microbiota
Measured: 3 months and 6 months
Fecal short chain fatty acids
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startApr 2006
- Primary completionSep 2007
- Study completionDec 2007
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 InfectionStudies 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puleva Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clinico Universitario San Cecilio
- Investigators
- José A Maldonado, PhD, MD, Principal investigator, Department of Pediatrics. Hospital Universitario San CecilioMónica Olivares, PhD, Study chair, Department of Nutrition and Health. Puleva Biotech. GranadaFederico Lara-Villoslada, PhD, Study director, Department of Nutrition and Helath. Puleva Biotech. Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724204
- Sponsor's protocol ID
- Safety Salivarius
- Acronym
- P010
- Status last verified
- Jul 2008
- First submitted
- 28 Jul 2008
- Last updated
- 29 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maldonado J, Lara-Villoslada F, Sierra S, Sempere L, Gomez M, Rodriguez JM, Boza J, Xaus J, Olivares M. Safety and tolerance of the human milk probiotic strain Lactobacillus salivarius CECT5713 in 6-month-old children. Nutrition. 2010 Nov-Dec;26(11-12):1082-7. doi: 10.1016/j.nut.2009.08.023. Epub 2009 Dec 16.
PubMed 20018483
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Evaluation of a Follow on Formula Supplemented With Lactobacillus Salivarius CECT5713
- ClinicalTrials.gov ID
- NCT00724204
- Acronym / sponsor ID
- P010 / Safety Salivarius
- Conditions
- Infection
- Keywords
- probiotics, safety, fecal microbiota, infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Puleva BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Clinico Universitario San Cecilio
- Study start
- Apr 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 29 Jul 2008 (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.
The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out. Eighty six months old children were recruited by the department of pediatrics of Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a follow on formula supplemented or not with the probiotic strain during 6 months. Fecal samples were obtained at the recruitment, at 3 months and at the end of the trial. In addition revision by the pediatrician was performed once a month and possible adverse effects were recorded both by the pediatrician and by parents.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Dietary Supplement: follow on formula without probioticsChildren that consumed a follow on formula without Lactobacillus salivarius CECT5713 |
| B | Active comparator | Dietary Supplement: follow on formula with Lactobacillus salivarius CECT5713Children that consumed a follow on formula with Lactobacillus salivarius CECT5713 |
Who may qualify
- Ages
- 6 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy six months old children
Key exclusion criteria (5 listed)
- Lactose intolerance
- Cow's milk protein allergy
- Serious metabolic diseases
- Antibiotic treatment
- Serious gastrointestinal diseases
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 without probioticsA follow on formula without probiotics | Dietary supplement | A |
| follow on formula with Lactobacillus salivarius CECT5713follow on formula with Lactobacillus salivarius CECT5713 in a dose of 2x10E8 cfu/day | Dietary supplement | B |
Primary outcome
Adverse reactions
Time frame: 3 months and 6 months
3 secondary outcomes
growth parameters (height, length, head circumference)
Time frame: 3 months and 6 months
Fecal microbiota
Time frame: 3 months and 6 months
Fecal short chain fatty acids
Time frame: 3 months and 6 months
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 29 Jul 2008.
- Derived from this study: PubMed 20018483Maldonado J, Lara-Villoslada F, Sierra S, Sempere L, Gomez M, Rodriguez JM, Boza J, Xaus J, Olivares M. Safety and tolerance of the human milk probiotic strain Lactobacillus salivarius CECT5713 in 6-month-old children. Nutrition. 2010 Nov-Dec;26(11-12):1082-7. doi: 10.1016/j.nut.2009.08.023. Epub 2009 Dec 16.
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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.
José A Maldonado, PhD, MD principal investigator
Department of Pediatrics. Hospital Universitario San Cecilio
Mónica Olivares, PhD study chair
Department of Nutrition and Health. Puleva Biotech. Granada
Federico Lara-Villoslada, PhD study director
Department of Nutrition and Helath. Puleva Biotech. Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing follow on formula without probiotics and follow on formula with Lactobacillus salivarius CECT5713 in people with Infection, run by Puleva Biotech 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 1 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 29 Jul 2008. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse reactions (time frame: 3 months and 6 months). 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 NCT00724204, 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 29 Jul 2008.