Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula

Assiut University

Status: Not yet enrolling

Conditions: Cow's Milk Protein Allergy Protein Intolerance Failure to Thrive

Study type: Observational

Funder types: Other

Identifiers

NCT07174999

AA-Formula-Study-2025

Details and patient eligibility

About

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.

Full 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 (weight, length, head circumference) will be recorded monthly. Growth velocity and nutritional status will be analyzed and compared with WHO growth standards.

Enrollment: 160 estimated patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Infants aged 1 to 12 months at the time of enrollment.
2. Infants who are exclusevel or predominantly fed amino acid-based formula (AAF) in addition to elimination diet for at least 12 consecutive weeks.
3. Infants who are diagnosed as CMPA by CoMiSS score ≥ 10 and confirmed by OFC test.
4. Infants with informed parental or guardian consent to participate in the study.

Exclusion criteria

• 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.

Trial design

160 participants in 1 patient group

Study Population

Description:

Infants receiving amino acid-based formula who are evaluated at the Nutrition and Gastroenterology Departments, Assiut University Children's Hospital.