Mineral Status Ininfants With Cow's Milk Protein Allergy

NCT04327297 | Unknown

• 1 other identifier: Msoiwcmpabaaraabf
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cow Milk Allergy

Keywords

Mineral status

Outcome Measures

Primary Outcomes (1)

• 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)

  1year

Interventions

Amino acid-based formula DIETARY_SUPPLEMENT

Amino acid based formula is formula which is used as dietary supplement instead of dairy products in cow's milk allergic infants

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants from 1 month to six months

You may qualify if:

• Infants 1 to 6 months old.
• Diagnosed as cow's milk protein allergic infants according to Cow's Milk-related-Symptom-Score(CoMiSS)(14).

You may not qualify if:

• Age: more than 3 month old infants.
• Previously diagnosed to have any gastrointestinal or systemic disease other than CMPA.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 28604516 RESULT

• Koletzko 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.

  PMID: 22569527 RESULT

• Maslin 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.

  PMID: 27257475 RESULT

• Martorell-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.

  PMID: 25800671 RESULT

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Jaafar I. Mohamad, Professor

CONTACT

01020627864; Gafaribrahim@yahoo.com

Amir M. Ano El-gheit, Lecturer

CONTACT

01065742277; Amircle76@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 31, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2021
• Last Updated: March 31, 2020

Record last verified: 2019-09