AllergyNCT01727115
Althera® Versus Nutramigen / Cow's Milk Intolerance
A study testing Infant Formula Feeding in people with Allergy, run by Société des Produits Nestlé (SPN) at 14 sites in Belgium.
Trial summary
The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in efficacy than NUTRAMIGEN® Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Allergy
- What is being tested?
- Infant Formula Feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 14 sitesBelgium
- Study dates
- Apr 2008to Jul 2011
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants from few days of life until 6 months of age
- Birth weight : between 2.500g and 4.500g
- Full term: gestational age between 37 and 42 weeks
- Singleton birth
- Suspicion of a mild/moderate Cow's Milk Proteins Intolerance (CMPI)
- Having obtained the Informed Consent by the Parents or the legal guardian
Who cannot join
- Exclusive breastfeeding at time of enrolment
- Having been treated before enrolment with an extensively hydrolysed formula
- Disease impairing a normal gut transit (like pyloric stenosis)
- Intolerance to lactose (if already known)
- Receiving an antibiotic treatment at the time of enrolment
- Severe or chronic diarrhea
Show all 11Show fewer
- Failure to thrive
- Neurologic diseases
- Receiving a medical treatment which could interfere with the protocol or after a surgical intervention
- Infants whose parents / caregivers who cannot be expected to comply with treatment
- Currently participating or having participated in another interventional clinical trial
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Belgium14 sites
ASZ
Aalst, Aalst, 9300
ZNA Middelheim
Antwerp, Antwerp, 2020
CHU Huderf
Brussels, Brussels Capital, 1020
AZ VUB
Brussels, Brussels Capital, 1090
Cliniques Universitaires
Brussels, Brussels Capital, 1200
Az Maria Middelares
Ghent, Gent, 9000
UZ Gent Pediatrie
Ghent, Gent, 9000
Clinique de l'Espérance
Montegnée, Montegnée, 4420
Centre Hospitalier Regional
Namur, Namur, 5000
Clinique Saint Pierre
Ottignies, Ottignies, 1340
Maria Ziekenhuis
Overpelt, Overpelt, 3900
Az Vesalius
Tongeren, Tongeren, 3700
CH WAPI Tournai
Tournai, Tournai, 7500
Sint Augustinus
Wilrijk, Wilrijk, 2610
About this study
Official title: Comparison of Two Extensively Hydrolyzed Formulas for the Treatment of Children With Cow's Milk Intolerance
The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in efficacy than NUTRAMIGEN®
- Conditions
- Allergy
- Being tested
- Infant Formula Feeding
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Formula FeedingOther
Assigned formula (Althera® or Nutramigen®) for a 4 weeks period.
- If the challenge is positive: The children continue the assigned formula
- If the challenge is negative: A Follow up formula is given
- (Nan pro2) if child > 6 months
- (Nan pro1) if child < 6 months
| Study group | Role | What they receive |
|---|---|---|
| NUTRAMIGEN® | Active comparator | Subjects are orally fed ad libitum (following guidelines printed on the labels).
Subjects will receive the Nutramigen® formula for a 4 week period
Then depending of the result of the challenge test we have the following possibilities:
* If the test is positive: The children continue the formula Nutramigen®
* If the test is negative: A Follow up formula is given
* (Nan pro2) if child > 6 months
* (Nan pro1) if child < 6 months Receives: Other: Infant Formula Feeding |
| ALTHERA® | Experimental | Subjects are orally fed ad libitum (following guidelines printed on the labels).
Subjects will receive the Althera® formula for a 4 week period
Then depending of the result of the challenge test we have the following possibilities:
* If the test is positive: The children continue the formula Althera®
* If the test is negative: A Follow up formula is given
* (Nan pro2) if child > 6 months
* (Nan pro1) if child < 6 months Receives: Other: Infant Formula Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome are regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms after 4 weeks of treatment.
regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms
Measured: 4 weeks
Secondary outcomes (1)
To assess whether the 2 groups have comparable changes in weight, length and head circumference
weight, length, head circumference
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startApr 2008
- Primary completionOct 2010
- Study completionJul 2011
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.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvan Vandenplas, Professor, Principal investigator, AZ-Kinderen V.U.B.Bruno Hauser, Doctor, Principal investigator, AZ-Kinderen V.U.B.Thierry Devreker, Doctor, Principal investigator, AZ-Kinderen V.U.B.Marc Verghote, Doctor, Principal investigator, CHR NamurChristine Halut, Doctor, Principal investigator, CHR NamurOlivia Bauraind, Doctor, Principal investigator, Clinique Saint PierreSandra Mulier, Doctor, Principal investigator, CHU des Enfants Reine FabiolaPascal Lenoir, Doctor, Principal investigator, Clinique Notre Dame Tournai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727115
- Sponsor's protocol ID
- 06.04.INF
- Status last verified
- Nov 2012
- First submitted
- 12 Nov 2012
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vandenplas Y, Steenhout P, Planoudis Y, Grathwohl D; Althera Study Group. Treating cow's milk protein allergy: a double-blind randomized trial comparing two extensively hydrolysed formulas with probiotics. Acta Paediatr. 2013 Oct;102(10):990-8. doi: 10.1111/apa.12349. Epub 2013 Aug 5.
PubMed 23837862
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Extensively Hydrolyzed Formulas for the Treatment of Children With Cow's Milk Intolerance
- ClinicalTrials.gov ID
- NCT01727115
- Acronym / sponsor ID
- 06.04.INF
- Conditions
- Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Nov 2012 (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 primary objective of this study is to demonstrate that ALTHERA® is equal or superior in efficacy than NUTRAMIGEN®
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NUTRAMIGEN® | Active comparator | Other: Infant Formula FeedingSubjects are orally fed ad libitum (following guidelines printed on the labels). Subjects will receive the Nutramigen® formula for a 4 week period Then depending of the result of the challenge test we have the following possibilities: * If the test is positive: The children continue the formula Nutramigen® * If the test is negative: A Follow up formula is given * (Nan pro2) if child > 6 months * (Nan pro1) if child < 6 months |
| ALTHERA® | Experimental | Other: Infant Formula FeedingSubjects are orally fed ad libitum (following guidelines printed on the labels). Subjects will receive the Althera® formula for a 4 week period Then depending of the result of the challenge test we have the following possibilities: * If the test is positive: The children continue the formula Althera® * If the test is negative: A Follow up formula is given * (Nan pro2) if child > 6 months * (Nan pro1) if child < 6 months |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants from few days of life until 6 months of age
- Birth weight : between 2.500g and 4.500g
- Full term: gestational age between 37 and 42 weeks
- Singleton birth
- Suspicion of a mild/moderate Cow's Milk Proteins Intolerance (CMPI)
Key exclusion criteria (11 listed)
- Exclusive breastfeeding at time of enrolment
- Having been treated before enrolment with an extensively hydrolysed formula
- Disease impairing a normal gut transit (like pyloric stenosis)
- Intolerance to lactose (if already known)
- Receiving an antibiotic treatment 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 FeedingAssigned formula (Althera® or Nutramigen®) for a 4 weeks period. * If the challenge is positive: The children continue the assigned formula * If the challenge is negative: A Follow up formula is given * (Nan pro2) if child > 6 months * (Nan pro1) if child < 6 months | Other | ALTHERA®, NUTRAMIGEN® |
Primary outcome
The primary outcome are regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms after 4 weeks of treatment.
Time frame: 4 weeks
regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms
1 secondary outcome
To assess whether the 2 groups have comparable changes in weight, length and head circumference
Time frame: 1 year
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 15 Nov 2012.
- Derived from this study: PubMed 23837862Vandenplas Y, Steenhout P, Planoudis Y, Grathwohl D; Althera Study Group. Treating cow's milk protein allergy: a double-blind randomized trial comparing two extensively hydrolysed formulas with probiotics. Acta Paediatr. 2013 Oct;102(10):990-8. doi: 10.1111/apa.12349. Epub 2013 Aug 5.
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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.
Yvan Vandenplas, Professor principal investigator
AZ-Kinderen V.U.B.
Bruno Hauser, Doctor principal investigator
AZ-Kinderen V.U.B.
Thierry Devreker, Doctor principal investigator
AZ-Kinderen V.U.B.
14 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 Feeding in people with Allergy, run by Société des Produits Nestlé (SPN) at 14 sites in Belgium.
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 11 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 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Belgium. 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?
The primary outcome are regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms after 4 weeks of treatment. (time frame: 4 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 NCT01727115, 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 15 Nov 2012.