Cow Milk AllergyNCT04327297
Mineral Status Ininfants With Cow's Milk Protein Allergy
An observational study of Cow Milk Allergy, run by Assiut University.
Trial summary
This study evaluate the mineral status of infants with cow's milk protein allergy which is affected due to the elimination of milk , and the change in this mineral status after receiving amino acid - based formula for 12 weeks. Read more about this study
- Who is it for?
- Ages 1 month to 6 months
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- Amino acid-based formula
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Nov 2021
- 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 1 month to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants from 1 month to six months
Who may be able to join
- Infants 1 to 6 months old.
- Diagnosed as cow's milk protein allergic infants according to Cow's Milk-related-Symptom-Score(CoMiSS)(14).
Who cannot join
- Age: more than 3 month old infants.
- Previously diagnosed to have any gastrointestinal or systemic disease other than CMPA.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mineral Status in Infants With Cow's Milk Protein Allergy Before and After Receiving Amino Acid-based Formula (AAF)
This study evaluate the mineral status of infants with cow's milk protein allergy which is affected due to the elimination of milk , and the change in this mineral status after receiving amino acid - based formula for 12 weeks.
Read the detailed description
Introduction Food allergy is defined as an adverse health effect arising from a specific Immune response that occurs following ingestion of a given food . Cow's milk protein (CMP) is the leading cause of food allergy in infants and young children younger than 3 years .Cow's milk contains at least 25 different proteins , all of which may act as antigens .
Prevelance Cow's milk protein allergy (CMPA) does seem to peak in the first year of life, with a prevalence of approximately 2% to 3% in the Infant population . This prevalence then falls to <1% in children 6 years of age and older . A few exclusively breast-fed infants may also develop clinically significant CMPA via dairy protein transfer into human breast milk .
Clinical presentation Manifestations of CMPA may involve many different organ systems mostly the skin and the gastrointestinal and respiratory tract . Skin: Urticaria, Atopic dermatitis. Gastrointestinal: perioral swelling , vomiting, regurgitation, early Satiety, diarrhea (+/-malabsorption or protein loss enteropathy) , failure to thrive, abdominal colic and persistent constipation . Respiratory: runny nose, wheezing and chronic cough. General manifestation: anaphylaxis leading to death in sensitized patient .
Diagnostic procedures Thorough medical history and physical examination. Skin prick test (SPT) and the determination of specific Ig-E in a blood sample. Allergen elimination and controlled challenge procedure. Cow's Milk-related-Symptom-Score (CoMiSS).
A Cow's Milk-related Symptom-Score (CoMiSS) is a score that considers general manifestations ,dermatological and respiratory symptoms.It was developed to be used as an awareness tool for cow's milk related symptoms. It also can be used to evaluate and quantify the evolution of symptoms during therapeutic interventions.
Mineral elements in milk and their nutritional importance There is a sufficient evidence that minerals, both independently or in proper balance with other minerals, have structural, biochemical and nutritional functions that are very important for overall human health, both mental and physical . Furthermore, they act as catalysts for many biological reactions in the body, including muscle contraction, transmission of nerve impulses and utilization of nutrients from food .Many mineral elements are essential in human nutrition: sodium, potassium, chloride, calcium, manganese, selenium, iodine, cobalt .All essential mineral elements can be found in milk because by definition it contains the nutrients required for growth of the young .
Cow milk protein allergy and mineral status
Adequate nutritional intake in infancy is essential to ensure appropriate physiological and mental development .Exclusion diets, in particular cows' milk exclusion diets, have been associated with poor growth in childhood ; as eliminating dairy products in diets of CMP allergic infants ,as well as, coexisting feeding problems ,can result in removing a substantial source of minerals which are involved in essential body functions .This avoidance should ideally be supported by input from an allergy dietitian to monitor and optimise the nutritional content of the diet and to maintain potential growth .
The following treatment options are available for infants with CMPA
- Hypoallergenic extensively hydrolyzed formulas (eHF) of cow's milk proteins,theses formulas are of choice in patients with CMPA, however, allergic reactions have been reported in children extremely sensitive to cow's milk .
- Milk derived from purified soya proteins. However, the use of soya is not recommended as a substitute in infants with CMPA under 6 months of age .
- Milk derived from partial rice protein hydrolysis formulas; they have scant sensitising capacity and do not produce adverse reactions .
- Free amino acid -based formulas (AAF). Amino acid-based formulas (AAF) Formula containing free amino acids as the only nitrogen source. An (eHF) is recommended for infants with mild to moderate CMA, whereas initiation with an (AAF) is recommended for more severe or complex allergy or when symptom-resolution with (eHF) fails or when (eHF)s are rejected by the patients due to playability problems . Dietary management of CMA with an AAF has been proven to be well-tolerated, effective, and safe; adequate infant growth on an AAF has widely been reported .
- Conditions
- Cow Milk Allergy
- Being tested
- Amino acid-based formula
- Keywords
- Mineral status
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acid-based formulaDietary supplement
Amino acid based formula is formula which is used as dietary supplement instead of dairy products in cow's milk allergic infants
What is being measured
The primary outcome is the main question the study is designed to answer.
blood sample
blood sample will be taken to assess/measure the mineral status(including:sodium,potassium,chloride,phosphorus,calcium,magnesium) of infants aged (1-6 months ) diagnosed as cow's milk protein allergy before receiving amino acid - based formula (at start of the study) and after receiving amino acid based formula (for 12 weeks)
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cow Milk AllergyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, israa hosni, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327297
- Sponsor's protocol ID
- Msoiwcmpabaaraabf
- Status last verified
- Sep 2019
- First submitted
- 10 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Harvey BM, Eussen SRBM, Harthoorn LF, Burks AW. Mineral Intake and Status of Cow's Milk Allergic Infants Consuming an Amino Acid-based Formula. J Pediatr Gastroenterol Nutr. 2017 Sep;65(3):346-349. doi: 10.1097/MPG.0000000000001655.
PubMed 28604516Koletzko S, Niggemann B, Arato A, Dias JA, Heuschkel R, Husby S, Mearin ML, Papadopoulou A, Ruemmele FM, Staiano A, Schappi MG, Vandenplas Y; European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Diagnostic approach and management of cow's-milk protein allergy in infants and children: ESPGHAN GI Committee practical guidelines. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):221-9. doi: 10.1097/MPG.0b013e31825c9482.
PubMed 22569527Maslin K, Oliver EM, Scally KS, Atkinson J, Foote K, Venter C, Roberts G, Grimshaw KE. Nutritional adequacy of a cows' milk exclusion diet in infancy. Clin Transl Allergy. 2016 Jun 2;6:20. doi: 10.1186/s13601-016-0109-8. eCollection 2016.
PubMed 27257475Martorell-Aragones A, Echeverria-Zudaire L, Alonso-Lebrero E, Bone-Calvo J, Martin-Munoz MF, Nevot-Falco S, Piquer-Gibert M, Valdesoiro-Navarrete L; Food allergy committee of SEICAP (Spanish Society of Pediatric Allergy, Asthma and Clinical Immunology). Position document: IgE-mediated cow's milk allergy. Allergol Immunopathol (Madr). 2015 Sep-Oct;43(5):507-26. doi: 10.1016/j.aller.2015.01.003. Epub 2015 Mar 20.
PubMed 25800671
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mineral Status in Infants With Cow's Milk Protein Allergy Before and After Receiving Amino Acid-based Formula (AAF)
- ClinicalTrials.gov ID
- NCT04327297
- Acronym / sponsor ID
- Msoiwcmpabaaraabf
- Conditions
- Cow Milk Allergy
- Keywords
- Mineral status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 31 Mar 2020 (actual)
- 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.
This study evaluate the mineral status of infants with cow's milk protein allergy which is affected due to the elimination of milk , and the change in this mineral status after receiving amino acid - based formula for 12 weeks.
Detailed description
Introduction Food allergy is defined as an adverse health effect arising from a specific Immune response that occurs following ingestion of a given food . Cow's milk protein (CMP) is the leading cause of food allergy in infants and young children younger than 3 years .Cow's milk contains at least 25 different proteins , all of which may act as antigens .
Prevelance Cow's milk protein allergy (CMPA) does seem to peak in the first year of life, with a prevalence of approximately 2% to 3% in the Infant population . This prevalence then falls to <1% in children 6 years of age and older . A few exclusively breast-fed infants may also develop clinically significant CMPA via dairy protein transfer into human breast milk .
Clinical presentation Manifestations of CMPA may involve many different organ systems mostly the skin and the gastrointestinal and respiratory tract . Skin: Urticaria, Atopic dermatitis. Gastrointestinal: perioral swelling , vomiting, regurgitation, early Satiety, diarrhea (+/-malabsorption or protein loss enteropathy) , failure to thrive, abdominal colic and persistent constipation . Respiratory: runny nose, wheezing and chronic cough. General manifestation: anaphylaxis leading to death in sensitized patient .
Diagnostic procedures Thorough medical history and physical examination. Skin prick test (SPT) and the determination of specific Ig-E in a blood sample. Allergen elimination and controlled challenge procedure. Cow's Milk-related-Symptom-Score (CoMiSS).
A Cow's Milk-related Symptom-Score (CoMiSS) is a score that considers general manifestations ,dermatological and respiratory symptoms.It was developed to be used as an awareness tool for cow's milk related symptoms. It also can be used to evaluate and quantify the evolution of symptoms during therapeutic interventions.
Mineral elements in milk and their nutritional importance There is a sufficient evidence that minerals, both independently or in proper balance with other minerals, have structural, biochemical and nutritional functions that are very important for overall human health, both mental and physical . Furthermore, they act as catalysts for many biological reactions in the body, including muscle contraction, transmission of nerve impulses and utilization of nutrients from food .Many mineral elements are essential in human nutrition: sodium, potassium, chloride, calcium, manganese, selenium, iodine, cobalt .All essential mineral elements can be found in milk because by definition it contains the nutrients required for growth of the young .
Cow milk protein allergy and mineral status
Adequate nutritional intake in infancy is essential to ensure appropriate physiological and mental development .Exclusion diets, in particular cows' milk exclusion diets, have been associated with poor growth in childhood ; as eliminating dairy products in diets of CMP allergic infants ,as well as, coexisting feeding problems ,can result in removing a substantial source of minerals which are involved in essential body functions .This avoidance should ideally be supported by input from an allergy dietitian to monitor and optimise the nutritional content of the diet and to maintain potential growth .
The following treatment options are available for infants with CMPA
- Hypoallergenic extensively hydrolyzed formulas (eHF) of cow's milk proteins,theses formulas are of choice in patients with CMPA, however, allergic reactions have been reported in children extremely sensitive to cow's milk .
- Milk derived from purified soya proteins. However, the use of soya is not recommended as a substitute in infants with CMPA under 6 months of age .
- Milk derived from partial rice protein hydrolysis formulas; they have scant sensitising capacity and do not produce adverse reactions .
- Free amino acid -based formulas (AAF). Amino acid-based formulas (AAF) Formula containing free amino acids as the only nitrogen source. An (eHF) is recommended for infants with mild to moderate CMA, whereas initiation with an (AAF) is recommended for more severe or complex allergy or when symptom-resolution with (eHF) fails or when (eHF)s are rejected by the patients due to playability problems . Dietary management of CMA with an AAF has been proven to be well-tolerated, effective, and safe; adequate infant growth on an AAF has widely been reported .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants from 1 month to six months
Key inclusion criteria (2 listed)
- Infants 1 to 6 months old.
- Diagnosed as cow's milk protein allergic infants according to Cow's Milk-related-Symptom-Score(CoMiSS)(14).
Key exclusion criteria (2 listed)
- Age: more than 3 month old infants.
- Previously diagnosed to have any gastrointestinal or systemic disease other than CMPA.
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 |
|---|---|---|
| Amino acid-based formulaAmino acid based formula is formula which is used as dietary supplement instead of dairy products in cow's milk allergic infants | Dietary supplement | – |
Primary outcome
blood sample
Time frame: 1year
blood sample will be taken to assess/measure the mineral status(including:sodium,potassium,chloride,phosphorus,calcium,magnesium) of infants aged (1-6 months ) diagnosed as cow's milk protein allergy before receiving amino acid - based formula (at start of the study) and after receiving amino acid based formula (for 12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Results publication: PubMed 28604516Harvey BM, Eussen SRBM, Harthoorn LF, Burks AW. Mineral Intake and Status of Cow's Milk Allergic Infants Consuming an Amino Acid-based Formula. J Pediatr Gastroenterol Nutr. 2017 Sep;65(3):346-349. doi: 10.1097/MPG.0000000000001655.
- Results publication: PubMed 22569527Koletzko S, Niggemann B, Arato A, Dias JA, Heuschkel R, Husby S, Mearin ML, Papadopoulou A, Ruemmele FM, Staiano A, Schappi MG, Vandenplas Y; European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Diagnostic approach and management of cow's-milk protein allergy in infants and children: ESPGHAN GI Committee practical guidelines. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):221-9. doi: 10.1097/MPG.0b013e31825c9482.
- Results publication: PubMed 27257475Maslin K, Oliver EM, Scally KS, Atkinson J, Foote K, Venter C, Roberts G, Grimshaw KE. Nutritional adequacy of a cows' milk exclusion diet in infancy. Clin Transl Allergy. 2016 Jun 2;6:20. doi: 10.1186/s13601-016-0109-8. eCollection 2016.
- Results publication: PubMed 25800671Martorell-Aragones A, Echeverria-Zudaire L, Alonso-Lebrero E, Bone-Calvo J, Martin-Munoz MF, Nevot-Falco S, Piquer-Gibert M, Valdesoiro-Navarrete L; Food allergy committee of SEICAP (Spanish Society of Pediatric Allergy, Asthma and Clinical Immunology). Position document: IgE-mediated cow's milk allergy. Allergol Immunopathol (Madr). 2015 Sep-Oct;43(5):507-26. doi: 10.1016/j.aller.2015.01.003. Epub 2015 Mar 20.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow Milk Allergy, run by Assiut University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaafar I. Mohamad, Professor (01020627864, Gafaribrahim@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood sample (time frame: 1year). 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 NCT04327297, which also lists 4 linked publications.
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 31 Mar 2020.