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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	7 Months - 3 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Artificially fed infants whether exclusively or complementary. 2. Confirmed diagnosis of CMPA based on clinical symptoms and signs and followed by withdrawal open re-challenge test.

Exclusion Criteria:

1. Exclusively breast-fed infants. 2. Anaphylactic type. 3. Multiple food Allergies.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06130085
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ain Shams University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cow's Milk Protein Allergy

Additional Details

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.

Arms & Interventions

Arms

No Intervention: Infants Continuing on amino acid based formula after 6 months elimination

Active Comparator: Infants receiving partially hydrolyzed formula after 6 months of elimination diet

Interventions

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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