Gastrointestinal DiseasesGO-INFNCT02096302
The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health
A study testing Infant Formula with a novel probiotic CECT7210 and Standard formula in people with Gastrointestinal Diseases, run by Laboratorios Ordesa at 3 sites in Spain.
Trial summary
The purpose of this study is to determine whether an infant formula supplemented with a new probiotic CECT7210, is effective in reducing the incidence of infections, specially the gastrointestinal ones. Read more about this study
- Who is it for?
- Ages Up to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Infant Formula with a novel probiotic CECT7210 and Standard formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 3 sitesSpain
- Study dates
- Jan 2011to Jun 2013
- 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 Up to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full-term healthy newborns (>= 37 weeks)
- Birth weight between >=2.500g and <=4.500g)
- Normal growth curve (between 3-97 percentiles)
- 0-60 days of age on enrolment
- Maximum 30 days of breastfeeding
- Exclusively infant formula on enrolment
Show all 10Show fewer
- Breastfeeding or infant formula with pre/probiotics feeding stopped 15 days before enrolment
- Parents or caregivers agree to exclude any source of prebiotics or probiotics during the study
- Parents or caregivers agree to follow-on the study 12 weeks
- Informed consent signed ( Parent/Legal representative)
Who cannot join
- Congenital illness or malformation that may affect infant feeding and /or normal growth
- Significant pre-natal or post-natal diseases
- Infant's family history of atopy
- Any pathology related to the immune or gastrointestinal system.
- Suspected or known allergy to cow's milk protein
- Infants receiving pre or probiotics within less than 15 days prior to enrolment
- Infant's family who in the investigator's assessment cannot be expected to comply with the protocol
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitario La Paz
Madrid
Hospital Sant Joan de Reus
Reus, Tarragona
Hospital Joan XXIII
Tarragona
About this study
Official title: Evaluar el Efecto de Una fórmula Infantil Enriquecida Con el probiótico CECT7210 Sobre la Incidencia de Infecciones Gastrointestinales
The purpose of this study is to determine whether an infant formula supplemented with a new probiotic CECT7210, is effective in reducing the incidence of infections, specially the gastrointestinal ones.
Read the detailed description
This a multicenter, controlled, randomized, prospective, parallel, double-blinded study to evaluate the effect of an infant formula containing a new probiotic, Bifidobacterium longum biovar infantis CECT7210, on the incidence of diarrhea in healthy infants born at term. Infants will be randomized to take an standard infant formula or the infant formula with the probiotic CECT7210 during 12 weeks.
- Conditions
- Gastrointestinal Diseases
- Being tested
- Infant Formula with a novel probiotic CECT7210, Standard formula
- Keywords
- Probiotics, Infant Formula, Microbiota, Bifidobacterium longum biovar infantis CECT7210, Growth
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Formula with a novel probiotic CECT7210Dietary supplement
Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.
Standard formulaDietary supplement
Standard formula without probiotics
| Study group | Role | What they receive |
|---|---|---|
| Experimental Formula | Experimental | Infant formula with a novel probiotic CECT7210 Receives: Dietary Supplement: Infant Formula with a novel probiotic CECT7210 |
| Standard Formula | Active comparator | Standard infant formula without probiotics Receives: Dietary Supplement: Standard formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in diarrhea incidence
Differences between diarrhea incidence amongst groups from baseline to 12th weeks.
Measured: At 4th, 8th, 12th weeks
Secondary outcomes (5)
Changes in infections incidence
Differences between rate of infections or duration amongst groups.
Measured: At 4th, 8th, 12th weeks.
Changes in microbiota
Differences between faecal bacterial populations.
Measured: At 4th, 8th, 12th weeks
Changes in Immunoglobulin A secretor (IgAs)
Differences between faecal IgAs amongst groups.
Measured: At 4th and 12th weeks
Tolerability of the product
To evaluate gastrointestinal tolerability of both study formulas.
Measured: At 4th, 8th and 12th weeks
Growth
To compare anthropometric measurements between probiotic CECT7210 formula group and standard group.
Measured: At 4th, 8th and 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harrison Clinical Research
- Responsible party
- Sponsor
- Investigators
- Isabel Polanco, Professor, Study chair, Hospital Universitario La PazJoaquin Escribano, Professor, Principal investigator, Hospital Sant Joan de Reus, Reus, SpainRicardo Closa, Professor, Principal investigator, Hospital Joan XXIII de Tarragona, Tarragona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096302
- Sponsor's protocol ID
- GO-INF-010
- Acronym
- GO-INF
- Status last verified
- Jul 2019
- First submitted
- 20 Mar 2014
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Closa R, Ferré N, Luque V, Gispert-Llaurado M, Ruibio-Torrents C, Polanco I, Morera M, Moreno JA, Rivero M, Escribano J. Effect of probiotic CECT7210 supplementation of infant formula in healthy infants. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PA-N-0038.
Moreno JA, Cifuentes GC, Morera M, Martínez-Blach JF, Codoñer F, Genovés S, Chenoll E, Polanco I, Closa R, Escribano J, Ferré N, Luque V, Rivero M. Feeding infant formula supplemented with the probiotic bacteria bifidobacterium longum subsp.infantis CECT7210 produce beneficial changes in gastointestinal microbial communities: a metagenomic approach. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PO-N-0361.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluar el Efecto de Una fórmula Infantil Enriquecida Con el probiótico CECT7210 Sobre la Incidencia de Infecciones Gastrointestinales
- ClinicalTrials.gov ID
- NCT02096302
- Acronym / sponsor ID
- GO-INF / GO-INF-010
- Conditions
- Gastrointestinal Diseases
- Keywords
- Probiotics, Infant Formula, Microbiota, Bifidobacterium longum biovar infantis CECT7210, Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Collaborators
- Harrison Clinical Research
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Mar 2014 (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 purpose of this study is to determine whether an infant formula supplemented with a new probiotic CECT7210, is effective in reducing the incidence of infections, specially the gastrointestinal ones.
Detailed description
This a multicenter, controlled, randomized, prospective, parallel, double-blinded study to evaluate the effect of an infant formula containing a new probiotic, Bifidobacterium longum biovar infantis CECT7210, on the incidence of diarrhea in healthy infants born at term. Infants will be randomized to take an standard infant formula or the infant formula with the probiotic CECT7210 during 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Formula | Experimental | Dietary Supplement: Infant Formula with a novel probiotic CECT7210Infant formula with a novel probiotic CECT7210 |
| Standard Formula | Active comparator | Dietary Supplement: Standard formulaStandard infant formula without probiotics |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Full-term healthy newborns (>= 37 weeks)
- Birth weight between >=2.500g and <=4.500g)
- Normal growth curve (between 3-97 percentiles)
- 0-60 days of age on enrolment
- Maximum 30 days of breastfeeding
Key exclusion criteria (7 listed)
- Congenital illness or malformation that may affect infant feeding and /or normal growth
- Significant pre-natal or post-natal diseases
- Infant's family history of atopy
- Any pathology related to the immune or gastrointestinal system.
- Suspected or known allergy to cow's milk protein
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 Formula with a novel probiotic CECT7210Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life. | Dietary supplement | Experimental Formula |
| Standard formulaStandard formula without probiotics | Dietary supplement | Standard Formula |
Primary outcome
Changes in diarrhea incidence
Time frame: At 4th, 8th, 12th weeks
Differences between diarrhea incidence amongst groups from baseline to 12th weeks.
5 secondary outcomes
Changes in infections incidence
Time frame: At 4th, 8th, 12th weeks.
Changes in microbiota
Time frame: At 4th, 8th, 12th weeks
Changes in Immunoglobulin A secretor (IgAs)
Time frame: At 4th and 12th weeks
Tolerability of the product
Time frame: At 4th, 8th and 12th weeks
Growth
Time frame: At 4th, 8th and 12th weeks
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 19 Jul 2019.
- Results publicationClosa R, Ferré N, Luque V, Gispert-Llaurado M, Ruibio-Torrents C, Polanco I, Morera M, Moreno JA, Rivero M, Escribano J. Effect of probiotic CECT7210 supplementation of infant formula in healthy infants. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PA-N-0038.
- Results publicationMoreno JA, Cifuentes GC, Morera M, Martínez-Blach JF, Codoñer F, Genovés S, Chenoll E, Polanco I, Closa R, Escribano J, Ferré N, Luque V, Rivero M. Feeding infant formula supplemented with the probiotic bacteria bifidobacterium longum subsp.infantis CECT7210 produce beneficial changes in gastointestinal microbial communities: a metagenomic approach. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PO-N-0361.
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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.
Isabel Polanco, Professor study chair
Hospital Universitario La Paz
Joaquin Escribano, Professor principal investigator
Hospital Sant Joan de Reus, Reus, Spain
Ricardo Closa, Professor principal investigator
Hospital Joan XXIII de Tarragona, Tarragona, Spain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula with a novel probiotic CECT7210 and Standard formula in people with Gastrointestinal Diseases, run by Laboratorios Ordesa at 3 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 10 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Changes in diarrhea incidence (time frame: At 4th, 8th, 12th weeks). 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 NCT02096302, which also lists 2 linked publications.
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 19 Jul 2019.