Cow's Milk AllergyNCT01809951
Isomil Post Marketing Observational Study
An observational study of Cow's Milk Allergy, run by Melva Louisa at 1 site in Indonesia.
Trial summary
The use of soy-isolate protein based formula for infants with cow's milk protein intolerance is common in Indonesia, however, there has not been any systematic collection of clinical data to determine the formula's gastrointestinal tolerance, and the parent's perceptions regarding the formula. Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- Cow's Milk Allergy
- How many people
- 534 participants
- Where
- 1 siteIndonesia
- Study dates
- Aug 2011to Jul 2013
- Phase
- Observational
- 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 6 to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants with symptoms suggestive adverse reactions to cow's milk protein
Who may be able to join
- infants of 6 - 12 months of age
- full term infants
- birth weight more than 2500 grams
- infants developed symptoms suggestive adverse reactions to cow's milk protein in the investigator's clinical judgements
- subject is prescribed a soy-based infant formula by physician
Who cannot join
- established/suspected hypersensitivity fo soy
- presence of adverse reactions to cow's milk caused by coincidental infections or other systemic disease
- history of blood group incompatibility, premature delivery, HIV infections, major congenital abnormalities, systemic diseases
- presence of severe gastrointestinal disorder
- subject is participating in any interventional clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-label, Post-marketing Observational Study to Document the Use of Soy-based Infant Formula With Low Chain Polyunsaturates (LCP) in Infants With Symptoms Suggestive to Cow's Milk Allergy
The use of soy-isolate protein based formula for infants with cow's milk protein intolerance is common in Indonesia, however, there has not been any systematic collection of clinical data to determine the formula's gastrointestinal tolerance, and the parent's perceptions regarding the formula.
- Conditions
- Cow's Milk Allergy
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Isomil Advance with LCP | 4 spoonful of Isomil Advance with LCP in 240 mL of water, 4 times a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent's acceptance in the feeding of a soy-based infant formula with LCP in infants with symptoms suggestive adverse reactions to cow milk protein
Measured: 4-week
Secondary outcomes (2)
percentage of infants with gastrointestinal adverse events
Measured: 4-week
percentage of infants with adverse events
Measured: 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startAug 2011
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melva Louisa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melva Louisa, Universitas Indonesia
- Investigators
- Zakiudin Munasir, MD, PhD, Principal investigator, Division of allergy and Immunology, Department of Child Health, Faculty of Medicine, Universitas IndonesiaSumadiono, MD, PhD, Study chair, RS Sardjito, Jl Kesehatan No 1 YogyakartaAnang Endaryanto, MD, PhD, Study chair, Allergy Immunology Working Unit, East Java Branch of Indonesian Pediatric SocietyDina Muktiarti, MD, Study chair, Sub Divisi Alergi Imunologi IKA FKUI, JakartaDewi Kumara Wati, MD, PhD, Study chair, RSUP Sanglah, Jl Kesehatan No 1-10 Denpasar BaliBudi Setiabudiawan, MD, PhD, Study chair, RS Hasan Sadikin Jl Pasteur No 38 Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809951
- Sponsor's protocol ID
- ANID-1101
- Status last verified
- Jun 2017
- First submitted
- 25 Jan 2013
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Post-marketing Observational Study to Document the Use of Soy-based Infant Formula With Low Chain Polyunsaturates (LCP) in Infants With Symptoms Suggestive to Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT01809951
- Acronym / sponsor ID
- ANID-1101
- Conditions
- Cow's Milk Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Melva LouisaUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Mar 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 use of soy-isolate protein based formula for infants with cow's milk protein intolerance is common in Indonesia, however, there has not been any systematic collection of clinical data to determine the formula's gastrointestinal tolerance, and the parent's perceptions regarding the formula.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isomil Advance with LCP | – | –4 spoonful of Isomil Advance with LCP in 240 mL of water, 4 times a day |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with symptoms suggestive adverse reactions to cow's milk protein
Key inclusion criteria (5 listed)
- infants of 6 - 12 months of age
- full term infants
- birth weight more than 2500 grams
- infants developed symptoms suggestive adverse reactions to cow's milk protein in the investigator's clinical judgements
- subject is prescribed a soy-based infant formula by physician
Key exclusion criteria (5 listed)
- established/suspected hypersensitivity fo soy
- presence of adverse reactions to cow's milk caused by coincidental infections or other systemic disease
- history of blood group incompatibility, premature delivery, HIV infections, major congenital abnormalities, systemic diseases
- presence of severe gastrointestinal disorder
- subject is participating in any interventional clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parent's acceptance in the feeding of a soy-based infant formula with LCP in infants with symptoms suggestive adverse reactions to cow milk protein
Time frame: 4-week
2 secondary outcomes
percentage of infants with gastrointestinal adverse events
Time frame: 4-week
percentage of infants with adverse events
Time frame: 4-week
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 16 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Cow's Milk Allergy
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Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
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Infant Formula in Infants and Children With Cow's Milk Allergy
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A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy
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TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)
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Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
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.
Zakiudin Munasir, MD, PhD principal investigator
Division of allergy and Immunology, Department of Child Health, Faculty of Medicine, Universitas Indonesia
Sumadiono, MD, PhD study chair
RS Sardjito, Jl Kesehatan No 1 Yogyakarta
Anang Endaryanto, MD, PhD study chair
Allergy Immunology Working Unit, East Java Branch of Indonesian Pediatric Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow's Milk Allergy, run by Melva Louisa at 1 site in Indonesia.
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 5 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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?
Parent's acceptance in the feeding of a soy-based infant formula with LCP in infants with symptoms suggestive adverse reactions to cow milk protein (time frame: 4-week). 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 16 Jun 2017.