Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cow's Milk Protein Allergy Protein Intolerance Failure to Thrive

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study Population

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No