Status:
NOT_YET_RECRUITING
Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula
Lead Sponsor:
Assiut University
Conditions:
Cow's Milk Protein Allergy Protein Intolerance Failure to Thrive
Eligibility:
All Genders
1-12 years
Brief Summary
This study aims to evaluate the growth parameters and nutritional status of infants who are receiving amino acid-based formula due to cow's milk protein allergy or other medical indications.
Detailed Description
This prospective observational study will assess infants who are exclusively fed amino acid-based formula. Participants will be followed over a period of 6 months, and anthropometric measurements (wei...
Eligibility Criteria
Inclusion
- Infants aged 1 to 12 months at the time of enrollment.
- Infants who are exclusevel or predominantly fed amino acid-based formula (AAF) in addition to elimination diet for at least 12 consecutive weeks.
- Infants who are diagnosed as CMPA by CoMiSS score ≥ 10 and confirmed by OFC test.
- Infants with informed parental or guardian consent to participate in the study.
Exclusion
- 1- Infants with congenital anomalies or syndromes affecting growth and development (e.g., trisomy 21, major cardiac defects).
- 2- Infants with chronic systemic illnesses unrelated to feeding (e.g., cystic fibrosis, chronic kidney disease).
- 3- Infants receiving additional specialized nutrition support (e.g., parenteral nutrition or tube feeding not involving AAF).
- 4- Infants with incomplete or insufficient medical records at the time of assessment.5- Infants who have been on AAF for less than 4 weeks or whose feeding regimen is not stable.
- 6- Infants whose parents or legal guardians decline or withdraw informed consent.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT07174999
Start Date
January 1 2026
End Date
December 30 2026
Last Update
September 16 2025
Active Locations (1)
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1
Assiut University
Asyut, Egypt