Incidence of Infectious DiseasesPhase 2/3NCT01215656
Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections
A Phase 2/3 study testing Lactobacillus fermentum and Follow on formula without probiotics in people with Incidence of Infectious Diseases, run by Puleva Biotech.
Trial summary
The objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants. Read more about this study
- Who is it for?
- Ages 6 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Incidence of Infectious Diseases
- What is being tested?
- Lactobacillus fermentum and Follow on formula without probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Jan 2010
- Phase
- Phase 2/3
- 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 6 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6 months old children born at term
- written consent from parents
Who cannot join
- frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux)
- gastrointestinal surgery
- cow's milk protein allergy
- metabolic diseases (diabetes or lactose intolerance)
- immune deficiency
- antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)
About this study
The objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants.
- Conditions
- Incidence of Infectious Diseases
- Being tested
- Lactobacillus fermentum, Follow on formula without probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus fermentumDietary supplement
Follow on formula without probioticsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | follow on formula with the probiotic Lactobacillus fermentum Receives: Dietary Supplement: Lactobacillus fermentum |
| Control | Active comparator | follow on formula without probiotics Receives: Dietary Supplement: Follow on formula without probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infectious diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startMay 2008
- Primary completionJan 2010
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 Incidence of Infectious DiseasesStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puleva Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215656
- Sponsor's protocol ID
- L. fermentum infections
- Status last verified
- Oct 2010
- First submitted
- 5 Oct 2010
- Last updated
- 7 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maldonado J, Canabate F, Sempere L, Vela F, Sanchez AR, Narbona E, Lopez-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respiratory tract infections in infants. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):55-61. doi: 10.1097/MPG.0b013e3182333f18.
PubMed 21873895
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections
- ClinicalTrials.gov ID
- NCT01215656
- Acronym / sponsor ID
- L. fermentum infections
- Conditions
- Incidence of Infectious Diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Puleva BiotechIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jan 2010 (actual)
- First posted
- 6 Oct 2010 (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 objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Lactobacillus fermentumfollow on formula with the probiotic Lactobacillus fermentum |
| Control | Active comparator | Dietary Supplement: Follow on formula without probioticsfollow on formula without probiotics |
Who may qualify
- Ages
- 6 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6 months old children born at term
- written consent from parents
Key exclusion criteria (6 listed)
- frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux)
- gastrointestinal surgery
- cow's milk protein allergy
- metabolic diseases (diabetes or lactose intolerance)
- immune deficiency
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 |
|---|---|---|
| Lactobacillus fermentum | Dietary supplement | Probiotic |
| Follow on formula without probiotics | Dietary supplement | Control |
Primary outcome
Incidence of infectious diseases
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 7 Oct 2010.
- Derived from this study: PubMed 21873895Maldonado J, Canabate F, Sempere L, Vela F, Sanchez AR, Narbona E, Lopez-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respiratory tract infections in infants. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):55-61. doi: 10.1097/MPG.0b013e3182333f18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lactobacillus fermentum and Follow on formula without probiotics in people with Incidence of Infectious Diseases, run by Puleva Biotech.
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 6 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 7 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of infectious diseases. 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 NCT01215656, 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 7 Oct 2010.