Infant NutritionNCT03204630
Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk
A study testing Lfer and Bifido in people with Infant Nutrition, run by Biosearch S.A. at 2 sites in Spain.
Trial summary
A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). Read more about this study
- Who is it for?
- Ages 3 to 5 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition
- What is being tested?
- Lfer and Bifido
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2011to Dec 2015
- 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 3 to 5 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborn infants at term (37-42 weeks gestational age) healthy during the first month of life, for reasons unrelated to the study, abandon breastfeeding during the first month of life.
- Signature of informed parental or guardian consent.
Who cannot join
- Allergic to the protein in cow's milk.
- Lactose intolerant.
- Suffering from a serious metabolic disease.
- They have experienced or are experiencing some severe gastrointestinal disease.
- Receive some form of chronic medication or are receiving antibiotics at the time of capture.
- Low expectation of compliance with the study protocol.
- allergic to any group of antibiotics.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Reina Sofía
Córdoba, 14004
Servicio Andaluz de Salud
Granada, 10012
About this study
A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). The primary outcome of the study is the body weight gain of infants. Secondary outcomes are incidence of infections, symptoms related with intestinal function, and fecal microbiota
- Conditions
- Infant Nutrition
- Being tested
- Lfer, Bifido, Control
- Keywords
- infant nutrition, probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LferDietary supplement
Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716
BifidoDietary supplement
Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263
ControlOther
Standard infant formula
| Study group | Role | What they receive |
|---|---|---|
| Bifido | Active comparator | Infant formula containing Bifidobacterium breve CECT7263 Receives: Dietary Supplement: Bifido |
| Lfer | Active comparator | Infant formula containing Lactobacillus fermentum CECT5716 Receives: Dietary Supplement: Lfer |
| Control | Placebo comparator | Standard infant formula Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight gain
Body weight gain at 12 months (grams)
Measured: 12 months versus baseline
Secondary outcomes (10)
Length
Length (cm)
Measured: 1,2,4,6,9 and 12 months of age
Body weight
Body weight of infants at different times (kg)
Measured: 1,2,4,6,9 and 12 months of age
Incidence of infections
Events of infections diseases during intervention period (Incidence rate)
Measured: total incidence during intervention (11 months)
Bacterial load in feces
Counts of Lactobacillus, bifidobacteria, bacteroides, clostridium (CFU/g feces)
Measured: 1,2,4,6,9 and 12 months of age
Regurgitation
Measurement by score: 1 = not at all, 2 = regurgitation of small amounts during or shortly after feeding, 3 = larger regurgitation during or shortly after feeding, 4 = minor vomiting with time-lag to prior feeding, and 5 = severe vomiting with considerable loss of fluid.
Measured: each 2 weeks until 6 months of age and monthly until 12 months of age
Fecal deposition
Measurement by score:1 = <1 time, 2 = 1-3, 3 = 4-6, 4 = 7-10, and 5 = >10.
Measured: each 2 weeks until 6 months of age and monthly until 12 months of age
Infant colic
Average crying hours per day during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age. Score: no crying; < 3 hours/day; 3-6 hours/day; 6-12 hours/day; > 12 hours/day
Measured: each 2 weeks until 6 months of age and monthly until 12 months of age
Flatulency
Average of duration of flatulence episodes (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score:no flatulency; < 3 hours/day; 3-6 hours/day; 6-12 hours/day; > 12 hours/day
Measured: each 2 weeks until 6 months of age and monthly until 12 months of age
Hours of night sleep
Average of time of night sleep (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score: < 4 hours ; 4-6 hours; 6-9 hours; 9-12 hours; > 12 hours
Measured: each 2 weeks until 6 months of age and monthly until 12 months of age
Total hours of sleep/day
Average of total time of sleep (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score: < 11 hours; 11-14 hours; 14-17 hours; 17-20 hours; > 20 hours
Measured: each 2 weeks until 6 months of age and monthly until 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startJan 2011
- Primary completionNov 2014
- Study completionDec 2015
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 Infant NutritionStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maimónides Biomedical Research Institute of Córdoba, Andaluz Health Service
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204630
- Sponsor's protocol ID
- P024
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Maldonado J, Gil-Campos M, Maldonado-Lobon JA, Benavides MR, Flores-Rojas K, Jaldo R, Jimenez Del Barco I, Bolivar V, Valero AD, Prados E, Penalver I, Olivares M. Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial. BMC Pediatr. 2019 Oct 21;19(1):361. doi: 10.1186/s12887-019-1753-7.
PubMed 31630683
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk
- ClinicalTrials.gov ID
- NCT03204630
- Acronym / sponsor ID
- P024
- Conditions
- Infant Nutrition
- Keywords
- infant nutrition, probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Collaborators
- Maimónides Biomedical Research Institute of Córdoba, Andaluz Health Service
- Study start
- Jan 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Jul 2017 (actual)
- 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.
A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). The primary outcome of the study is the body weight gain of infants. Secondary outcomes are incidence of infections, symptoms related with intestinal function, and fecal microbiota
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bifido | Active comparator | Dietary Supplement: BifidoInfant formula containing Bifidobacterium breve CECT7263 |
| Lfer | Active comparator | Dietary Supplement: LferInfant formula containing Lactobacillus fermentum CECT5716 |
| Control | Placebo comparator | Other: ControlStandard infant formula |
Who may qualify
- Ages
- 3 to 5 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborn infants at term (37-42 weeks gestational age) healthy during the first month of life, for reasons unrelated to the study, abandon breastfeeding during the first month of life.
- Signature of informed parental or guardian consent.
Key exclusion criteria (7 listed)
- Allergic to the protein in cow's milk.
- Lactose intolerant.
- Suffering from a serious metabolic disease.
- They have experienced or are experiencing some severe gastrointestinal disease.
- Receive some form of chronic medication or are receiving antibiotics at the time of capture.
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 |
|---|---|---|
| LferProbiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716 | Dietary supplement | Lfer |
| BifidoProbiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263 | Dietary supplement | Bifido |
| ControlStandard infant formula | Other | Control |
Primary outcome
Body weight gain
Time frame: 12 months versus baseline
Body weight gain at 12 months (grams)
10 secondary outcomes
Length
Time frame: 1,2,4,6,9 and 12 months of age
Body weight
Time frame: 1,2,4,6,9 and 12 months of age
Incidence of infections
Time frame: total incidence during intervention (11 months)
Bacterial load in feces
Time frame: 1,2,4,6,9 and 12 months of age
Regurgitation
Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Fecal deposition
Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Infant colic
Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Flatulency
Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Hours of night sleep
Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Total hours of sleep/day
Time frame: each 2 weeks until 6 months of age and monthly until 12 months of age
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 2 Jul 2017.
- Derived from this study: PubMed 31630683Maldonado J, Gil-Campos M, Maldonado-Lobon JA, Benavides MR, Flores-Rojas K, Jaldo R, Jimenez Del Barco I, Bolivar V, Valero AD, Prados E, Penalver I, Olivares M. Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial. BMC Pediatr. 2019 Oct 21;19(1):361. doi: 10.1186/s12887-019-1753-7.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lfer and Bifido in people with Infant Nutrition, run by Biosearch S.A. at 2 sites 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 7 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Body weight gain (time frame: 12 months versus baseline). 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 NCT03204630, 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 2 Jul 2017.