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

Cow's Milk Protein Allergy Clinical Trial

Official title: Open Labeled Randomized Clinical Trial of Introduction of a Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination Protocol

Status Not yet recruiting

Clinical Trial 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. Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months.

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.

They were followed up for manifestations of intolerance to pHF. Infant who showed manifestations of intolerance were returned to AAF and continued for 6 months with AAF.

Final step: Reintoduction of CMPs After 12 months of elimination of CMPs, evaluation of tolerance to whole CMPs was done by oral food challenge (OFC).

For infants who were still non-tolerant to CMPs after 12 months of elimination were followed up and re-challenged after 6 months.

Clinical Trial Description

Phase Ⅰ:Initial assessment at enrollment i. Full medical history taking: with emphasis on:

Personal History: Age- Sex- Order of birth- Consanguinity-Residence

Main presenting symptoms:

A- Gastrointestinal symptoms: at initial diagnosis According to the clinical presentations, following clinical diagnoses were identified GERD, FPIAP, FPIES, FPE, constipation and combination of symptoms as shown in the following table.

B- Associated systemic allergic manifestations: at initial diagnosis C- CoMiSS: Cow's Milk-related Symptom Score (CoMiSS) at presentation. CMPA diagnosis was confirmed by an elimination diet followed by an oral food challenge.

D- Course of the disease:

E- Dietary and nutritional history:

1. Breast Feeding: If Yes exclusive for how long?

2. Artificial feeding: Age of start, type of formula, Indication.

3. Weaning: Time of start, Type of food given (each food and time of introduction especially cow's milk and CMPs), Any problems during weaning (gastrointestinal, respiratory or skin allergies) and eliciting dose of milk products that caused symptoms.

4. Accidental intake of raw or heated milk during elimination period and its consequences.

• Past history: mode of delivery

• Family history: atopy, siblings with CMPA

• Medication history: Antireflux medications, laxatives, probiotics. ii. Clinical examination:

• Anthropometric measurements: (weight &height on Z score, Wt/Ht ratio) using WHO 2006 Growth charts to those aged ≤ 2 years & CDC Growth charts 2000 if >2 years old

• Signs of allergy: (atopic dermatitis- allergic rhinitis-wheezy chest)

• Abdomen:(Distension- Tenderness- organomegaly)

• Perineal area: (Perianal inflammation, napkin rash)

Phase 2: Elimination of CMPs for 6 months. All infants were supplemented with Amino Acid-based Formula (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet. Cow's-milk-based formula and supplementary foods containing CMPs, other animal milk proteins (eg, goat's milk, sheep's milk) were strictly avoided due to cross reactivity.

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 Breast feeding mothers excluding cow's milk were prescribed a supplement of 1000 mg of calcium & 10 µg (400 IU) of vitamin D every day

Phase III: Intervention after completing 6 months of eliminating CMPs

o The included patients were randomly assigned to one of (2 groups).

1. Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months.

2. Group II (pHF group) n= 50 Infants in this group were shifted gradually the same way as OFC (from Amino Acid-based Formula; to Partially-hydrolyzed whey formula (Liptomil Plus HA infant formula; for another 6 months with continuation of elimination of CMPs.

They were followed up for manifestations of intolerance to pHF. Infant who showed manifestations of intolerance were returned to AAF and continued for 6 months with AAF.

Phase IV: Reintroduction of CMPs After 12 months of elimination of CMPs, evaluation of tolerance to whole CMPs was done by OFC. Tolerance was established by a negative challenge followed by regular ingestion of age-appropriate quantities of cow's milk at home without symptoms, where patients were followed up again for one month to detect any symptoms of intolerance after regular ingestion of milk products

For infants who were still non-tolerant to CMPs after 12 months of elimination were followed up and re-challenged after 6 months. ;

Related Conditions & MeSH terms

• Cow's Milk Protein Allergy
• Food Hypersensitivity
• Hypersensitivity
• Milk Hypersensitivity

• NCT number: NCT06130085
• Study type: Interventional
• Source: Ain Shams University
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Completion date: December 2024