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NCT06130085
Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination
NA trial testing Partially hydrolyzed formula in Cow's Milk Protein Allergy in 100 participants. Completed in 28 March 2025.
15 January 2025
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 15 January 2024 |
| Primary completion | 15 January 2025 |
| Estimated completion | 28 March 2025 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Partially hydrolyzed formula
Conditions studied
- Cow's Milk Protein Allergy — all drugs for Cow's Milk Protein Allergy →
Sponsor
Ain Shams University
Who can join
Adults 7 Months to 3, any sex, with Cow's Milk Protein Allergy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06130085
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Related trials
Other recruiting trials for Cow's Milk Protein Allergy
Currently open trials in the same condition.
- NCT07448740 — Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk Allergy Observational · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06130085 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
- Last refreshed: 7 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06130085.
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