Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination

NCT06130085 | Completed

• 1 other identifier: MD444/2017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

For Patients diagnosed as cow milk protein allergy: Elimination of cow's milk products (CMPs) for 6 months. All infants were supplemented with Amino Acid-based Formula (AAF) (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet. For mixed milk fed infants (still receiving breast milk with the formula), mothers were encouraged to continue breast-feeding while avoiding all milk and milk products from their own diet. Intervention after completing 6 months of eliminating CMPs. The included patients were randomly assigned to one of (2 groups).

1. 1.Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months.
2. 2.Group II (pHF group) n= 50 Infants in this group were shifted gradually to Partially-hydrolyzed whey formula (pHF) (Liptomil Plus HA infant formula. for another 6 months with continuation of elimination of cow's milk products.

Conditions

Cow's Milk Protein Allergy

Outcome Measures

Primary Outcomes (1)

• compare the rate of tolerance to cow milk products among patients allocated to partially hydrolyzed formula after 6 months of milk free diet compared to those who completed 1 year of elimination

  Questionnaire done to assess occurrence of following symptoms Vomiting, Hematemesis, Diarrhea (using BRISTOL scale), Constipation, Eczema, Skin rash, Perianal inflammation, weight loss in kilograms or failure to gain weight in kilograms, (Colic, Straining and marked Abdominal distension), skin rash, angioedema, and recurrent respiratory symptoms within two months of following up after milk reintroduction. If any of the previous items is present, then the patient is considered intolerant to milk. All items should be answered by (no) in order to consider the patient tolerant to milk

  At the month 13 for both groups and for extra more 30 days of regular ingestion of cow's milk products

Secondary Outcomes (1)

• Tolerance to pHF after 6 months elimination diet

  At the seventh month in the group allocated to receive pHF after six months of elimination diet

Study Arms (2)

Infants Continuing on amino acid based formula after 6 months elimination

NO INTERVENTION

Infants receiving partially hydrolyzed formula after 6 months of elimination diet

ACTIVE COMPARATOR

Dietary Supplement: Partially hydrolyzed formula

Interventions

Partially hydrolyzed formula DIETARY_SUPPLEMENT

Partially hydrolyzed formula given as the milk supplement for cow milk allergy patients after 6 months of strict elimination diet

Infants receiving partially hydrolyzed formula after 6 months of elimination diet

Eligibility Criteria

• Age: 7 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Artificially fed infants whether exclusively or complementary.
• Confirmed diagnosis of CMPA based on clinical symptoms and signs and followed by withdrawal open re-challenge test

You may not qualify if:

• Exclusively breast-fed infants.
• Anaphylactic type.
• Multiple food Allergies.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (6)

• Vandenplas Y, Dupont C, Eigenmann P, Host A, Kuitunen M, Ribes-Koninckx C, Shah N, Shamir R, Staiano A, Szajewska H, Von Berg A. A workshop report on the development of the Cow's Milk-related Symptom Score awareness tool for young children. Acta Paediatr. 2015 Apr;104(4):334-9. doi: 10.1111/apa.12902. Epub 2015 Jan 29.

  PMID: 25557474 BACKGROUND

• Nowak-Wegrzyn A, Chehade M, Groetch ME, Spergel JM, Wood RA, Allen K, Atkins D, Bahna S, Barad AV, Berin C, Brown Whitehorn T, Burks AW, Caubet JC, Cianferoni A, Conte M, Davis C, Fiocchi A, Grimshaw K, Gupta R, Hofmeister B, Hwang JB, Katz Y, Konstantinou GN, Leonard SA, Lightdale J, McGhee S, Mehr S, Sopo SM, Monti G, Muraro A, Noel SK, Nomura I, Noone S, Sampson HA, Schultz F, Sicherer SH, Thompson CC, Turner PJ, Venter C, Westcott-Chavez AA, Greenhawt M. International consensus guidelines for the diagnosis and management of food protein-induced enterocolitis syndrome: Executive summary-Workgroup Report of the Adverse Reactions to Foods Committee, American Academy of Allergy, Asthma & Immunology. J Allergy Clin Immunol. 2017 Apr;139(4):1111-1126.e4. doi: 10.1016/j.jaci.2016.12.966. Epub 2017 Feb 4.

  PMID: 28167094 BACKGROUND

• Mehta NM, Corkins MR, Lyman B, Malone A, Goday PS, Carney LN, Monczka JL, Plogsted SW, Schwenk WF; American Society for Parenteral and Enteral Nutrition Board of Directors. Defining pediatric malnutrition: a paradigm shift toward etiology-related definitions. JPEN J Parenter Enteral Nutr. 2013 Jul;37(4):460-81. doi: 10.1177/0148607113479972. Epub 2013 Mar 25.

  PMID: 23528324 BACKGROUND

• Luyt D, Ball H, Makwana N, Green MR, Bravin K, Nasser SM, Clark AT; Standards of Care Committee (SOCC) of the British Society for Allergy and Clinical Immunology (BSACI). BSACI guideline for the diagnosis and management of cow's milk allergy. Clin Exp Allergy. 2014;44(5):642-72. doi: 10.1111/cea.12302.

  PMID: 24588904 BACKGROUND

• Ludman S, Shah N, Fox AT. Managing cows' milk allergy in children. BMJ. 2013 Sep 16;347:f5424. doi: 10.1136/bmj.f5424. No abstract available.

  PMID: 24041704 BACKGROUND

• Lightdale JR, Gremse DA; Section on Gastroenterology, Hepatology, and Nutrition. Gastroesophageal reflux: management guidance for the pediatrician. Pediatrics. 2013 May;131(5):e1684-95. doi: 10.1542/peds.2013-0421. Epub 2013 Apr 29.

  PMID: 23629618 BACKGROUND

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: November 13, 2023
• Study Start: January 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: March 28, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

EG (1)