HealthyNCT05303077
Study of the Effects of a New Infant Formula Supplemented With a Probiotic Over the Corporal Composition of Infants
A study testing Nutribén Innova® 1, Nutribén® and Breastfeed in people with Healthy, run by Alter Farmacia, S.A. at 21 sites in Spain.
Trial summary
This is a multicentric, randomized, blinded, controlled trial to study the effects of a new infant formula on the changes in the newborn body composition over time: weight gain, anthropometric data, incidence of infections, digestive tolerance (flatulence, vomiting and regurgitation), feces (consistency and… Read more about this study
- Who is it for?
- Ages 15 to 25 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nutribén Innova® 1, Nutribén® and Breastfeed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 21 sitesSpain
- Study dates
- 11 Feb 2019to 25 Nov 2020
- 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 15 to 25 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children. Both sex.
- Full term infants (between 37 and 42 weeks of pregnancy).
- Birth weight between 2500 g- 4500 g.
- Single birth babies.
- BMI of the mothers before the pregnancy between 19 y 30 kg/m2.
Who cannot join
- Body weight lower than the 5th percentile for their gestational age.
- Cow's milk protein allergy and/or lactose allergy.
- Administration of antibiotics 7 days prior inclusion.
- Congenital disease or malformation that may affect the infant growth rate.
- Population Description: The study population are newborns selected from primary care clinics in Spain.
- Sampling Method: Not applicable
Show all 13Show fewer
- Metabolic disease or disorders.
- Significant prenatal disease and/or serious postnatal disease before recruitment.
- Underage parents.
- Diabetic mother.
- Born from a drug abuse mother (who use abuse drugs during pregnancy).
- Parents cannot comply with study procedures.
- Subject included or that have been included in other clinical trial since his/her birth day.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Spain21 sites
Cap Montclar
Barcelona
Cap Nova Lloreda
Barcelona
Cap Sant Ildefons
Barcelona
Consulta Dr. Xavier Riopedre
Barcelona
Consulta Carlos Nuñez de Prado Aparicio
Madrid
Consultorio Arroyomolinos (Cs Parque Coimbra)
Madrid
Cs Alcalde Bartolomé Gonzalez Móstoles
Madrid
Cs Conde de Barcelona
Madrid
Cs Dr Luengo Rodríguez
Madrid
Cs Infante Don Luis de Borbón
Madrid
Cs La Rivota
Madrid
Cs Las Américas
Madrid
Cs Miguel Servet
Madrid
Cs Parque Loranca
Madrid
Cs Presentación Sabio
Madrid
Cs Valle de La Oliva
Madrid
Clínica Dr Aguilar-Dr Sacristán
Seville
Consultas Externas Hospital Privado Santa Ángela de La Cruz
Seville
Cs Amante Laffón
Seville
Cs Utrera Norte
Seville
Ihp Bellavista
Seville
About this study
Official title: The Effect of a New Newborn Formula Over the Corporal Composition: a Randomized Multicentric Clinical Trial
This is a multicentric, randomized, blinded, controlled trial to study the effects of a new infant formula on the changes in the newborn body composition over time: weight gain, anthropometric data, incidence of infections, digestive tolerance (flatulence, vomiting and regurgitation), feces (consistency and frequency), behavior (restlessness, colic, nocturnal awakenings), count of probiotic strains of the intestinal microbiota in feces, safety and tolerability of the investigational products (measured as number, frequency and severity of adverse events in all branches of the study)
- Conditions
- Healthy
- Being tested
- Nutribén Innova® 1, Nutribén®, Breastfeed
- Keywords
- Infant formula, body composition, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutribén Innova® 1Dietary supplement
Infants are fed solely with infant formula supplemented with an inactive probiotic and omega 3 fatty acids over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's
Nutribén®Dietary supplement
Infants are fed solely with infant formula over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's age.
BreastfeedDietary supplement
Infants are breastfeeding solely over the first 6 months of their life, from then on the infants are fed as recommended by their caregiver, as if they are not participating in a research study.
| Study group | Role | What they receive |
|---|---|---|
| Study Infant Formula | Experimental | Infant formula supplemented with omega 3 fatty acids and inactive Bifidobacteria Receives: Dietary Supplement: Nutribén Innova® 1 |
| Infant Formula | Active comparator | Infant formula Receives: Dietary Supplement: Nutribén® |
| Breastfeed Active comparator | Active comparator | Infants who are breastfed Receives: Dietary Supplement: Breastfeed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain at 6 months
Measure of weight gain by grams/day between the first visit and month 6
Measured: 6 months after the beginning of the study
Secondary outcomes (18)
weight at 21 days, 2, 4, 6 and 12 months
Measure of weight gain by grams
Measured: 21 days, 2, 4, 6 and 12 months
Length gain
Measure of the infant's length gain over time in cms
Measured: 21 days, 2, 4, 6 and 12 months
Head circumference gain
Measure of the increase of the head circumference over time in cms
Measured: 21 days, 2, 4, 6 and 12 months
Tricipital Skin fold development
Measurement of the development of tricipital skin fold, in cms, measured using a skinfold caliper
Measured: 4, 6 and 12 months
Subscapular skin fold develompent
Measurement of the development of subscapular skin fold, in cms, measured using a skinfold caliper
Measured: 4, 6 and 12 months
Mean arm circumference
Measure of arm circumference over time in cms.
Measured: 4, 6 and 12 months
Feces features consistency
Description of the consistency of baby's feces features, according to their parent's perception, on a qualitative scale: soft, hard, liquid, normal, semiliquid, pasty. The analysis includes the number of feces in each group and the overall frequency by study arm and visit.
Measured: 21 days, 2, 4, 6 and 12 months
Feces features number of bowel movements
Number of bowel movements per day sorted by study group
Measured: 21 days, 2, 4, 6 and 12 months
Digestive tolerance
The digestive tolerance will be assessed as adequate, constipation, flatulence, vomit or other distresses, which are a heterogeneous group that includes various affections as diarrhea, abdominal pain, irritability, constipation, regurgitation or colic. The analysis includes the overall number and the frequency sorted by study arm.
Measured: 4, 6 and 12 months
Infant's behavior
Qualitative variable. The infant's behavior is classified as either good or altered. The total number and the relative frequency by group are included in the analysis.
Measured: 4, 6 and 12 months
intestinal microbiota
Analysis of the evolution of the intestinal microbiota of the children over the study. The richness and diversity of the microbiota are analyzed and compared between the study groups.
Measured: 4, 6 and 12 months
Evolution of calprotectin levels in feces
Measurement of the evolution of calprotectin levels in feces over time
Measured: 21 days, 2, 6 and 12 months
Evolution of IgA levels in feces
Measurement of the evolution of IgA levels in feces over time
Measured: 21 days, 2, 6 and 12 months
Evolution lactic acid levels in feces
Measurement of the evolution of lactic acid levels in feces over time
Measured: 21 days, 2, 6 and 12 months
Evolution of short-chain fatty acid levels in feces
Measurement of the evolution of short-chain fatty acid levels in feces over time
Measured: 21 days, 2, 6 and 12 months
Morbility
Analysis of the number and frequency of all adverse events registered during the study by feeding group
Measured: over a year
Products Tolerability
Quantitative variable. The tolerability of the products is assessed as adequate, good, very good, unsatisfactory. The analysis includes the overall number y and the relative frequency by group.
Measured: over a year
Overall rate of the products
Quantitative variable. The parents' subjective rate of the products. The assessment can be, acceptable, good, very good, satisfactory or not satisfactory.
Measured: 2, 4, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start11 Feb 2019
- Primary completion25 Nov 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alter Farmacia, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundación Teófilo Hernando, Spain, Biopolis S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303077
- Sponsor's protocol ID
- INNOVA 2020
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a New Newborn Formula Over the Corporal Composition: a Randomized Multicentric Clinical Trial
- ClinicalTrials.gov ID
- NCT05303077
- Acronym / sponsor ID
- INNOVA 2020
- Conditions
- Healthy
- Keywords
- Infant formula, body composition, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Alter Farmacia, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Fundación Teófilo Hernando, Spain, Biopolis S.L.
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 31 Mar 2022 (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.
This is a multicentric, randomized, blinded, controlled trial to study the effects of a new infant formula on the changes in the newborn body composition over time: weight gain, anthropometric data, incidence of infections, digestive tolerance (flatulence, vomiting and regurgitation), feces (consistency and frequency), behavior (restlessness, colic, nocturnal awakenings), count of probiotic strains of the intestinal microbiota in feces, safety and tolerability of the investigational products (measured as number, frequency and severity of adverse events in all branches of the study)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Infant Formula | Experimental | Dietary Supplement: Nutribén Innova® 1Infant formula supplemented with omega 3 fatty acids and inactive Bifidobacteria |
| Infant Formula | Active comparator | Dietary Supplement: Nutribén®Infant formula |
| Breastfeed Active comparator | Active comparator | Dietary Supplement: BreastfeedInfants who are breastfed |
Who may qualify
- Ages
- 15 to 25 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children. Both sex.
- Full term infants (between 37 and 42 weeks of pregnancy).
- Birth weight between 2500 g- 4500 g.
- Single birth babies.
- BMI of the mothers before the pregnancy between 19 y 30 kg/m2.
Key exclusion criteria (13 listed)
- Body weight lower than the 5th percentile for their gestational age.
- Cow's milk protein allergy and/or lactose allergy.
- Administration of antibiotics 7 days prior inclusion.
- Congenital disease or malformation that may affect the infant growth rate.
- Population Description: The study population are newborns selected from primary care clinics in Spain.
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 |
|---|---|---|
| Nutribén Innova® 1Infants are fed solely with infant formula supplemented with an inactive probiotic and omega 3 fatty acids over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's | Dietary supplement | Study Infant Formula |
| Nutribén®Infants are fed solely with infant formula over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's age. | Dietary supplement | Infant Formula |
| BreastfeedInfants are breastfeeding solely over the first 6 months of their life, from then on the infants are fed as recommended by their caregiver, as if they are not participating in a research study. | Dietary supplement | Breastfeed Active comparator |
Primary outcome
Weight gain at 6 months
Time frame: 6 months after the beginning of the study
Measure of weight gain by grams/day between the first visit and month 6
18 secondary outcomes
weight at 21 days, 2, 4, 6 and 12 months
Time frame: 21 days, 2, 4, 6 and 12 months
Length gain
Time frame: 21 days, 2, 4, 6 and 12 months
Head circumference gain
Time frame: 21 days, 2, 4, 6 and 12 months
Tricipital Skin fold development
Time frame: 4, 6 and 12 months
Subscapular skin fold develompent
Time frame: 4, 6 and 12 months
Mean arm circumference
Time frame: 4, 6 and 12 months
Feces features consistency
Time frame: 21 days, 2, 4, 6 and 12 months
Feces features number of bowel movements
Time frame: 21 days, 2, 4, 6 and 12 months
Digestive tolerance
Time frame: 4, 6 and 12 months
Infant's behavior
Time frame: 4, 6 and 12 months
intestinal microbiota
Time frame: 4, 6 and 12 months
Evolution of calprotectin levels in feces
Time frame: 21 days, 2, 6 and 12 months
Evolution of IgA levels in feces
Time frame: 21 days, 2, 6 and 12 months
Evolution lactic acid levels in feces
Time frame: 21 days, 2, 6 and 12 months
Evolution of short-chain fatty acid levels in feces
Time frame: 21 days, 2, 6 and 12 months
Morbility
Time frame: over a year
Products Tolerability
Time frame: over a year
Overall rate of the products
Time frame: 2, 4, 6 and 12 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 7 Apr 2022.
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutribén Innova® 1, Nutribén® and Breastfeed in people with Healthy, run by Alter Farmacia, S.A. at 21 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 5 inclusion and 13 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 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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. 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?
Weight gain at 6 months (time frame: 6 months after the beginning of the study). 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 7 Apr 2022.