An interventional study of Partially hydrolyzed formula in Cow's Milk Protein Allergy, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 7 Months to 3 Years. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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).
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.
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:
Accidental intake of raw or heated milk during elimination period and its consequences.
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).
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.
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's enrollment of 100 is above the median of 68 across 95 interventional studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
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Exclusion Criteria:
Dietary Supplement: Partially hydrolyzed formula
Partially hydrolyzed formula given as the milk supplement for cow milk allergy patients after 6 months of strict elimination diet
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
Time frame: At the month 13 for both groups and for extra more 30 days of regular ingestion of cow's milk products
Tolerance to pHF after 6 months elimination diet
To assess tolerance to partially hydrolsed milk formula in the group assigned to ingest pHF via a 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 pHF.
Time frame: At the seventh month in the group allocated to receive pHF after six months of elimination diet
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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