Milk HypersensitivityNCT00792090
Prevention of Cow's Milk Allergy in Children
A study testing Fermented milk and Standard milk in people with Milk Hypersensitivity, run by Bledina at 2 sites in France.
Trial summary
Impact of fermented milk in prevention of cow's milk allergy in new born and infants Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Milk Hypersensitivity
- What is being tested?
- Fermented milk and Standard milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2003to Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- mother before the 5th month of pregnancy
- mother agreeing to stop consumption of yogurts and fermented milks during the 3rd quarter of pregnancy
- mother agreeing to receive a calcium supplementation during the 3rd quarter of pregnancy
- atopic mother or father and at least another atopic member (sister or brother)
- parents having given written informed consent
- adhesion to eviction regimen for mother and child
- parents agreeing with a regular follow-up (3 visits and monthly phone call with the dietician)
Who cannot join
- mother in an exclusion period from another study
- parents refusing to sign the informed consent
- 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
- known or suspected immunodeficiency in the family
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital central
Nancy, 57000
Hôpital Saint Vincent de Paul
Paris, 75014
About this study
Official title: Use of Fermented Milk in Prevention of Cow's Milk Allergy in New Born and Infant
Impact of fermented milk in prevention of cow's milk allergy in new born and infants
- Conditions
- Milk Hypersensitivity
- Being tested
- Fermented milk, Standard milk
- Keywords
- allergy, cow's milk, sensibilisation, fermented milk, infant formula
- Medical subject headings
- Milk Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented milkOther
Formula used for non breastfed children or in complement of breastfeeding
Standard milkOther
Formula used for non breastfed children or in complement of breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fermented milk Receives: Other: Fermented milk |
| 2 | Active comparator | Standard milk Receives: Other: Standard milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibilisation and cow's milk allergy
Measured: 4, 12 and 24 months
Secondary outcomes (2)
Sensitization or allergy to other allergens
Measured: 4, 12 and 24 months
Atopic diseases (atopic dermatitis, asthma)
Measured: 4, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startNov 2003
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Milk HypersensitivityStudies 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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bledina
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Optimed Medizinische Instrumente GmbH
- Investigators
- Christophe Dupont, PhD, Principal investigator, Hôpital Saint Vincent de PaulDenise-Anne Moneret-Vautrin, PhD, Principal investigator, Hôpital central
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792090
- Sponsor's protocol ID
- BL006
- Status last verified
- Nov 2008
- First submitted
- 14 Nov 2008
- Last updated
- 17 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Fermented Milk in Prevention of Cow's Milk Allergy in New Born and Infant
- ClinicalTrials.gov ID
- NCT00792090
- Acronym / sponsor ID
- BL006
- Conditions
- Milk Hypersensitivity
- Keywords
- allergy, cow's milk, sensibilisation, fermented milk, infant formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- BledinaIndustry (pharma, biotech, devices)
- Collaborators
- Optimed Medizinische Instrumente GmbH
- Study start
- Nov 2003
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 17 Nov 2008 (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.
Impact of fermented milk in prevention of cow's milk allergy in new born and infants
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 |
|---|---|---|
| 1 | Experimental | Other: Fermented milkFermented milk |
| 2 | Active comparator | Other: Standard milkStandard milk |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- mother before the 5th month of pregnancy
- mother agreeing to stop consumption of yogurts and fermented milks during the 3rd quarter of pregnancy
- mother agreeing to receive a calcium supplementation during the 3rd quarter of pregnancy
- atopic mother or father and at least another atopic member (sister or brother)
- parents having given written informed consent
Key exclusion criteria (4 listed)
- mother in an exclusion period from another study
- parents refusing to sign the informed consent
- 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
- known or suspected immunodeficiency in the family
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 |
|---|---|---|
| Fermented milkFormula used for non breastfed children or in complement of breastfeeding | Other | 1 |
| Standard milkFormula used for non breastfed children or in complement of breastfeeding | Other | 2 |
Primary outcome
Sensibilisation and cow's milk allergy
Time frame: 4, 12 and 24 months
2 secondary outcomes
Sensitization or allergy to other allergens
Time frame: 4, 12 and 24 months
Atopic diseases (atopic dermatitis, asthma)
Time frame: 4, 12 and 24 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 17 Nov 2008.
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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.
Christophe Dupont, PhD principal investigator
Hôpital Saint Vincent de Paul
Denise-Anne Moneret-Vautrin, PhD principal investigator
Hôpital central
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented milk and Standard milk in people with Milk Hypersensitivity, run by Bledina at 2 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 7 inclusion and 4 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 17 Nov 2008. 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 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?
Sensibilisation and cow's milk allergy (time frame: 4, 12 and 24 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 17 Nov 2008.