WeaningNCT00858026
Impact of a Fermented Infant Formula in Weaning Babies
A study testing Breastmilk, Standard milk and Fermented milk in people with Weaning, run by Bledina at 6 sites in France.
Trial summary
When mothers wanted to shift from breast milk to infant formulae, babies were randomly assigned to receive a fermented or a standard formula. Biological and clinical investigations were achieved at baseline (V1), and after one (V2) and three months (V3) of consumption of study formula. Read more about this study
- Who is it for?
- Ages 54 to 68 days
- Conditions the study is for
- Weaning
- What is being tested?
- Breastmilk, Standard milk and Fermented milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 6 sitesFrance
- Study dates
- Apr 2006to Jun 2008
- 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 54 to 68 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Eutrophic infants, (± 2SD), healthy, male or female, of 2 months of age (± 1 week)
- Born at 37 weeks of amenorrhea or more
- Exclusively breastfed since birth
- Written informed consent given by both parents (or tutors) for study participation
- Parents (or tutors) agreeing on the follow-up by one of the study investigators
Who cannot join
- Infant with congenital or acquired immunodeficiency, whatever the aetiology
- Infant with a significant metabolic, organic or bowel disease which could interfere with the results of the present study,
- Infant with congenital and/or chromosomal malformation,
- Infant having received antibiotic therapy within the 3 weeks before the inclusion visit
- infant receiving a treatment susceptible to interfere with the measure of study parameters
- Antibiotic therapy per/pre/post partum > 48 h
- Infant needing the prescription of a specific milk (HA, without cow milk)
- Infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Cabinet médical
Bondues, 59910
Cabinet médical
Dunkirk, 59240
Cabinet medical
Lambersart, 59130
Cabinet médical
Lille, 59000
Hôpital saint Vincent de Paul
Lille, 59000
Cabinet médical
Roncq, 59223
About this study
When mothers wanted to shift from breast milk to infant formulae, babies were randomly assigned to receive a fermented or a standard formula. Biological and clinical investigations were achieved at baseline (V1), and after one (V2) and three months (V3) of consumption of study formula. Intestinal microbiota was assessed by using culture-dependent techniques.
- Conditions
- Weaning
- Being tested
- Breastmilk, Standard milk, Fermented milk
- Keywords
- weaning, breastfeeding, infant formula, fermented formula
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastmilkOther
Also called No other names
Exclusively breastfed babies
Standard milkOther
Also called No other names
Weaning babies fed with the standard formula
Fermented milkOther
Also called No other names
Weaning babies fed with the fermented formula
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Breastfed babies Receives: Other: Breastmilk |
| 2 | Active comparator | Weaning with the standard milk Receives: Other: Standard milk |
| 3 | Experimental | Weaning with the fermented milk Receives: Other: Fermented milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the impact of a fermented infant formula on the intestinal microbiota in weaning babies
Measured: 2, 3 and 5 months of age
Secondary outcomes (7)
Describe the intestinal flora according to the nutrition group
Measured: 3 and 5 months of age
Compare the effect on enterobacteria and clostridium of a fermented formula vs. a standard formula toward the pursuit of breastfeeding
Measured: 3 months of age
Describe the growth, according to the nutrition group
Measured: 3 and 5 months of age
Describe the milk tolerance at the weaning according to the nutrition group
Measured: 3 and 5 months of age
Describe the infection signs according to the nutrition group
Measured: 3 and 5 months of age
Describe weight and height, current alimentation and potential infectious diseases since the visit at 5 months of age, according to the nutrition group
Measured: 9 months of age
Compare the effect on enterobacteria, clostridium and bifidobacteria of a fermented formula vs. a standard formula toward the pursuit of breastfeeding
Measured: 5 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 posted9 Mar 2009 (estimated)
- Study startApr 2006
- Primary completionNov 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WeaningStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bledina
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MAPI
- Investigators
- Nicolas Kalach, MD, Principal investigator, Hopital Saint Vincent de Paul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858026
- Sponsor's protocol ID
- BL009
- Status last verified
- Mar 2009
- First submitted
- 6 Mar 2009
- Last updated
- 9 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Fermented Infant Formula in Weaning Babies
- ClinicalTrials.gov ID
- NCT00858026
- Acronym / sponsor ID
- BL009
- Conditions
- Weaning
- Keywords
- weaning, breastfeeding, infant formula, fermented formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- BledinaIndustry (pharma, biotech, devices)
- Collaborators
- MAPI
- Study start
- Apr 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 9 Mar 2009 (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.
When mothers wanted to shift from breast milk to infant formulae, babies were randomly assigned to receive a fermented or a standard formula. Biological and clinical investigations were achieved at baseline (V1), and after one (V2) and three months (V3) of consumption of study formula. Intestinal microbiota was assessed by using culture-dependent techniques.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: BreastmilkBreastfed babies |
| 2 | Active comparator | Other: Standard milkWeaning with the standard milk |
| 3 | Experimental | Other: Fermented milkWeaning with the fermented milk |
Who may qualify
- Ages
- 54 to 68 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Eutrophic infants, (± 2SD), healthy, male or female, of 2 months of age (± 1 week)
- Born at 37 weeks of amenorrhea or more
- Exclusively breastfed since birth
- Written informed consent given by both parents (or tutors) for study participation
- Parents (or tutors) agreeing on the follow-up by one of the study investigators
Key exclusion criteria (8 listed)
- Infant with congenital or acquired immunodeficiency, whatever the aetiology
- Infant with a significant metabolic, organic or bowel disease which could interfere with the results of the present study,
- Infant with congenital and/or chromosomal malformation,
- Infant having received antibiotic therapy within the 3 weeks before the inclusion visit
- infant receiving a treatment susceptible to interfere with the measure of study parameters
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 |
|---|---|---|
| BreastmilkAlso: No other namesExclusively breastfed babies | Other | 1 |
| Standard milkAlso: No other namesWeaning babies fed with the standard formula | Other | 2 |
| Fermented milkAlso: No other namesWeaning babies fed with the fermented formula | Other | 3 |
Primary outcome
To determine the impact of a fermented infant formula on the intestinal microbiota in weaning babies
Time frame: 2, 3 and 5 months of age
7 secondary outcomes
Describe the intestinal flora according to the nutrition group
Time frame: 3 and 5 months of age
Compare the effect on enterobacteria and clostridium of a fermented formula vs. a standard formula toward the pursuit of breastfeeding
Time frame: 3 months of age
Describe the growth, according to the nutrition group
Time frame: 3 and 5 months of age
Describe the milk tolerance at the weaning according to the nutrition group
Time frame: 3 and 5 months of age
Describe the infection signs according to the nutrition group
Time frame: 3 and 5 months of age
Describe weight and height, current alimentation and potential infectious diseases since the visit at 5 months of age, according to the nutrition group
Time frame: 9 months of age
Compare the effect on enterobacteria, clostridium and bifidobacteria of a fermented formula vs. a standard formula toward the pursuit of breastfeeding
Time frame: 5 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 9 Mar 2009.
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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.
Nicolas Kalach, MD principal investigator
Hopital Saint Vincent de Paul
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastmilk, Standard milk and Fermented milk in people with Weaning, run by Bledina at 6 sites in France.
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 8 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 9 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
To determine the impact of a fermented infant formula on the intestinal microbiota in weaning babies (time frame: 2, 3 and 5 months of age). 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 9 Mar 2009.