AllergyNCT01181297
Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
A study testing Extensively Hydrolyzed Formula with a Probiotic and Extensively Hydrolyzed Formula without a Probiotic in people with Allergy, run by Mead Johnson Nutrition at 2 sites in 2 countries.
Trial summary
The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed formula with an added probiotic in children with documented milk allergy. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Allergy
- What is being tested?
- Extensively Hydrolyzed Formula with a Probiotic and Extensively Hydrolyzed Formula without a Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2003to Nov 2004
- 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 14 years
- Child
Who may be able to join
- ≤14 years of age
- Essentially asymptomatic for a minimum of 7 days pre-challenge.
- Successful previous consumption of Extensively Hydrolyzed Formula within 1 week of study enrollment
- Medically documented allergy to cow's milk
Who cannot join
- Presence of underlying systemic disease or other illness
- Used Beta-blockers within 12-24 hours of challenges
- Use of short-acting antihistamines within 3 days
- Use of medium-acting antihistamines within 7 days
- Use of long-acting antihistamines within 6 weeks
- Use of oral steroid medication within 3 weeks
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
Dept. of Paediatrics, Azienda Ospedaliera di Padova
Padova, Veneto, 35128
About this study
The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed formula with an added probiotic in children with documented milk allergy.
- Conditions
- Allergy
- Being tested
- Extensively Hydrolyzed Formula with a Probiotic, Extensively Hydrolyzed Formula without a Probiotic
- Keywords
- Confirmed milk allergy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensively Hydrolyzed Formula with a ProbioticOther
Extensively Hydrolyzed Formula without a ProbioticOther
| Study group | Role | What they receive |
|---|---|---|
| Extensively Hydrolyzed Formula with a Probiotic | Experimental | Extensively Hydrolyzed Formula with a Probiotic Receives: Other: Extensively Hydrolyzed Formula with a Probiotic |
| Extensively Hydrolyzed Formula without a Probiotic | Placebo comparator | Not described Receives: Other: Extensively Hydrolyzed Formula without a Probiotic |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startJan 2003
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies 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
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181297
- Sponsor's protocol ID
- 3369-2
- Status last verified
- Aug 2010
- First submitted
- 12 Aug 2010
- Last updated
- 13 Aug 2010
- Results posted
- No
Publications
Muraro A, Hoekstra MO, Meijer Y, Lifschitz C, Wampler JL, Harris C, Scalabrin DM. Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial. BMJ Open. 2012 Mar 5;2(2):e000637. doi: 10.1136/bmjopen-2011-000637. Print 2012.
PubMed 22396223
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
- ClinicalTrials.gov ID
- NCT01181297
- Acronym / sponsor ID
- 3369-2
- Conditions
- Allergy
- Keywords
- Confirmed milk allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 13 Aug 2010 (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 confirm the hypoallergenicity of an extensively hydrolyzed formula with an added probiotic in children with documented milk allergy.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extensively Hydrolyzed Formula with a Probiotic | Experimental | Other: Extensively Hydrolyzed Formula with a ProbioticExtensively Hydrolyzed Formula with a Probiotic |
| Extensively Hydrolyzed Formula without a Probiotic | Placebo comparator | Other: Extensively Hydrolyzed Formula without a Probiotic |
Who may qualify
- Ages
- Up to 14 years
- Age groups
- Child
Key inclusion criteria (4 listed)
- ≤14 years of age
- Essentially asymptomatic for a minimum of 7 days pre-challenge.
- Successful previous consumption of Extensively Hydrolyzed Formula within 1 week of study enrollment
- Medically documented allergy to cow's milk
Key exclusion criteria (6 listed)
- Presence of underlying systemic disease or other illness
- Used Beta-blockers within 12-24 hours of challenges
- Use of short-acting antihistamines within 3 days
- Use of medium-acting antihistamines within 7 days
- Use of long-acting antihistamines within 6 weeks
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 |
|---|---|---|
| Extensively Hydrolyzed Formula with a Probiotic | Other | Extensively Hydrolyzed Formula with a Probiotic |
| Extensively Hydrolyzed Formula without a Probiotic | Other | Extensively Hydrolyzed Formula without a Probiotic |
Primary outcome
Not reported in the source record.
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 Aug 2010.
- Derived from this study: PubMed 22396223Muraro A, Hoekstra MO, Meijer Y, Lifschitz C, Wampler JL, Harris C, Scalabrin DM. Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial. BMJ Open. 2012 Mar 5;2(2):e000637. doi: 10.1136/bmjopen-2011-000637. Print 2012.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extensively Hydrolyzed Formula with a Probiotic and Extensively Hydrolyzed Formula without a Probiotic in people with Allergy, run by Mead Johnson Nutrition at 2 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 4 inclusion and 6 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 Aug 2010. 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 Italy, Netherlands. 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. Some participants in this study may receive a placebo. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01181297, which also lists 1 linked publication.
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 Aug 2010.