HealthyPhase 2NCT01983072
Symbiotic & Colonization
A Phase 2 study testing Infant formula and Breastfeeding in people with Healthy, run by Société des Produits Nestlé (SPN) at 4 sites in 2 countries.
Trial summary
The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of… Read more about this study
- Who is it for?
- Ages Up to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Infant formula and Breastfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2008to Aug 2011
- Phase
- Phase 2
- 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 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn infant
- Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation)
- Age of infant is between 14 days at the time of enrollment
- Birth weight between 2500g and 4500g
- For the Formula fed groups: The infant's mother has elected, before the 14th day of their child's life, not to continue breastfeeding (no breastfeeding after the 14th day of the child's life) For the Breastfed group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age
- Having obtained his/her legal representative's informed consent
Who cannot join
- Congenital illness or malformation that may affect normal growth
- Significant pre-natal and/or post-natal disease
- Re-hospitalization for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
- Newborn who have received antibiotics during the first 14 days of life
- Receiving infant formula containing pro and/or prebiotics at the time of enrolment
- Newborn whose parents / caregivers cannot be expected to comply with treatment
- Newborn currently participating in another clinical trial
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
Hôpital Saint Joseph
Marseille, 13008
Hôpital de la Conception
Marseille, 13015
Hôpital Nord
Marseille, 13015
About this study
Official title: Effect of Starter Formula With Symbiotic on Microbiota Balance
The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.
Read the detailed description
The infants will be recruited and randomized between 0 and 14 days. The intervention period, in terms of data necessary for the primary outcome, will be until they reach 3 months old. Measurements will be collected on three separate occasions during this period, i.e. 2 and 6 weeks and 3 months. Stools will be collected, on 3 separate occasions, i.e. 4-5 day, 6 weeks and 3 months of life.
- Conditions
- Healthy
- Being tested
- Infant formula, Breastfeeding
- Keywords
- colonization of the gastrointestinal tract with bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaDietary supplement
BreastfeedingOther
Breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| Infant starter formula | Active comparator | standard infant formula Receives: Dietary Supplement: Infant formula |
| Infant starter formula + prebiotics + probiotics | Experimental | infant formula Receives: Dietary Supplement: Infant formula |
| Breastfeeding group | Other | reference group Receives: Other: Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
stool bacterial populations
(Lactobacilli, Clostridia, Bacteroides, bifidobacteria, staphylococci, Enterobacteria and Bifidobacterial species at 1.5 months and 3 months of age of the infants.
Measured: 3 months
Secondary outcomes (3)
changes in weight
weight
Measured: 3 months
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
Measured: 3 months
changes in length
changes in length
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startApr 2008
- Primary completionAug 2011
- Study completionAug 2011
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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hania Szajewska, Principal investigator, The Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983072
- Sponsor's protocol ID
- 06.08.INF
- Status last verified
- Nov 2013
- First submitted
- 29 Oct 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Starter Formula With Symbiotic on Microbiota Balance
- ClinicalTrials.gov ID
- NCT01983072
- Acronym / sponsor ID
- 06.08.INF
- Conditions
- Healthy
- Keywords
- colonization of the gastrointestinal tract with bacteria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Nov 2013 (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 clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.
Detailed description
The infants will be recruited and randomized between 0 and 14 days. The intervention period, in terms of data necessary for the primary outcome, will be until they reach 3 months old. Measurements will be collected on three separate occasions during this period, i.e. 2 and 6 weeks and 3 months. Stools will be collected, on 3 separate occasions, i.e. 4-5 day, 6 weeks and 3 months of life.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infant starter formula | Active comparator | Dietary Supplement: Infant formulastandard infant formula |
| Infant starter formula + prebiotics + probiotics | Experimental | Dietary Supplement: Infant formulainfant formula |
| Breastfeeding group | Other | Other: Breastfeedingreference group |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy newborn infant
- Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation)
- Age of infant is between 14 days at the time of enrollment
- Birth weight between 2500g and 4500g
- For the Formula fed groups: The infant's mother has elected, before the 14th day of their child's life, not to continue breastfeeding (no breastfeeding after the 14th day of the child's life) For the Breastfed group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age
Key exclusion criteria (7 listed)
- Congenital illness or malformation that may affect normal growth
- Significant pre-natal and/or post-natal disease
- Re-hospitalization for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
- Newborn who have received antibiotics during the first 14 days of life
- Receiving infant formula containing pro and/or prebiotics at the time of enrolment
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 | Dietary supplement | Infant starter formula, Infant starter formula + prebiotics + probiotics |
| BreastfeedingBreastfeeding | Other | Breastfeeding group |
Primary outcome
stool bacterial populations
Time frame: 3 months
(Lactobacilli, Clostridia, Bacteroides, bifidobacteria, staphylococci, Enterobacteria and Bifidobacterial species at 1.5 months and 3 months of age of the infants.
3 secondary outcomes
changes in weight
Time frame: 3 months
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
Time frame: 3 months
changes in length
Time frame: 3 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 13 Nov 2013.
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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.
Hania Szajewska principal investigator
The Medical University of Warsaw
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infant formula and Breastfeeding in people with Healthy, run by Société des Produits Nestlé (SPN) at 4 sites in 2 countries.
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 6 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 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Poland. 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.
What does this 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.
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?
stool bacterial populations (time frame: 3 months). 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 13 Nov 2013.