ToleranceNCT01346644
Safety of Lactobacillus Fermentum in Newborn Infants
A study testing Infant formula in people with Tolerance, run by Puleva Biotech at 1 site in Spain.
Trial summary
In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. Read more about this study
- Who is it for?
- Ages 21 to 30 days
- Conditions the study is for
- Tolerance
- What is being tested?
- Infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2009to not given
- 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 21 to 30 days
- All sexes
- Child
Who may be able to join
- Healthy 1 month infants exclusively formula-fed
Who cannot join
- gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux)
- gastrointestinal surgery
- cow's milk protein allergy
- metabolic disorders (diabetes, lactose intolerance)
- immune deficiency
- antibiotic prescription 1-week prior to inclusion and previous use of formula containing prebiotics or probiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Tolerance of an Infant Formula Supplemented With Lactobacillus Fermentum CECT5716
In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.
- Conditions
- Tolerance
- Being tested
- Infant formula
- Keywords
- Probiotic, infant nutrition, safety, infections
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaOther
Powder infant formula
Infant formulaOther
Powder infant formula
| Study group | Role | What they receive |
|---|---|---|
| No probiotics | Active comparator | Infant formula with no probiotics Receives: Other: Infant formula |
| Probiotic | Experimental | Infant formula supplemented with probiotic Receives: Other: Infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
average weight gain
Measured: 4 months
Secondary outcomes (1)
growth and health of infants
average weight, length of infants. Incidence of infections. Incidence of allergic diseases
Measured: 2,4,6,12 and 36 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startFeb 2009
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 ToleranceStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puleva Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mercedes Gil, Doctor, Principal investigator, Hospital Reina Sofía de Córdoba (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346644
- Sponsor's protocol ID
- P024
- Status last verified
- May 2013
- First submitted
- 1 May 2011
- Last updated
- 16 May 2013
- Results posted
- No
Publications
Maldonado-Lobon JA, Gil-Campos M, Maldonado J, Lopez-Huertas E, Flores-Rojas K, Valero AD, Rodriguez-Benitez MV, Banuelos O, Lara-Villoslada F, Fonolla J, Olivares M. Long-term safety of early consumption of Lactobacillus fermentum CECT5716: A 3-year follow-up of a randomized controlled trial. Pharmacol Res. 2015 May-Jun;95-96:12-9. doi: 10.1016/j.phrs.2015.01.006. Epub 2015 Feb 16.
PubMed 25697549
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tolerance of an Infant Formula Supplemented With Lactobacillus Fermentum CECT5716
- ClinicalTrials.gov ID
- NCT01346644
- Acronym / sponsor ID
- P024
- Conditions
- Tolerance
- Keywords
- Probiotic, infant nutrition, safety, infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Puleva BiotechIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- First posted
- 3 May 2011 (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 the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No probiotics | Active comparator | Other: Infant formulaInfant formula with no probiotics |
| Probiotic | Experimental | Other: Infant formulaInfant formula supplemented with probiotic |
Who may qualify
- Ages
- 21 to 30 days
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy 1 month infants exclusively formula-fed
Key exclusion criteria (6 listed)
- gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux)
- gastrointestinal surgery
- cow's milk protein allergy
- metabolic disorders (diabetes, 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 |
|---|---|---|
| Infant formulaPowder infant formula | Other | No probiotics |
| Infant formulaPowder infant formula | Other | Probiotic |
Primary outcome
average weight gain
Time frame: 4 months
1 secondary outcome
growth and health of infants
Time frame: 2,4,6,12 and 36 months of life
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 16 May 2013.
- Derived from this study: PubMed 25697549Maldonado-Lobon JA, Gil-Campos M, Maldonado J, Lopez-Huertas E, Flores-Rojas K, Valero AD, Rodriguez-Benitez MV, Banuelos O, Lara-Villoslada F, Fonolla J, Olivares M. Long-term safety of early consumption of Lactobacillus fermentum CECT5716: A 3-year follow-up of a randomized controlled trial. Pharmacol Res. 2015 May-Jun;95-96:12-9. doi: 10.1016/j.phrs.2015.01.006. Epub 2015 Feb 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.
Mercedes Gil, Doctor principal investigator
Hospital Reina Sofía de Córdoba (Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula in people with Tolerance, 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 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 16 May 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 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. 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?
average weight gain (time frame: 4 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 NCT01346644, 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 16 May 2013.