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NCT Number: NCT07174999

Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula

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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Key information

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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.

Treatment and study plan

Primary outcomes

  1. Mean anthropometric z-scores (WAZ, LAZ, WLZ)

    Time frame: Single assessment at enrollment.

    Mean weight-for-age, length-for-age, and weight-for-length z-scores for the study population compared to WHO reference.

  2. Weight-for-Age Z-score (WAZ) - prevalence of underweight

    Time frame: Single assessment at enrollment.

    Prevalence of underweight (weight-for-age z-score < -2) among infants receiving amino acid-based formula, calculated according to WHO growth standards.

  3. Nutritional Status (Weight-for-Age Z-sco

    Time frame: At the time of enrollment (single assessment).

    Assessment of weight-for-age z-score in infants receiving amino acid-based formula compared to WHO growth standards.

Secondary outcomes

  1. Length-for-Age Z-score

    Time frame: At the time of enrollment.

    Measurement of length-for-age z-score according to WHO growth standards.

  2. Head Circumference-for-Age Z-score

    Time frame: At the time of enrollment.

    Measurement of head circumference-for-age z-score according to WHO growth standards.

  3. Gastrointestinal Symptoms

    Time frame: At the time of enrollment (parental report).

    Assessment of gastrointestinal tolerance including vomiting, diarrhea, and constipation

Study contacts

Contact information is provided by the study sponsor or research team.

Merna Emeel Fahmy, MBBCh, Pediatric Resident

CONTACT

[email protected]

01202626579

Osama Mahmoud Elasheer, prof

CONTACT

[email protected]

01001348864

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Prospective Observational Study for Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula at Assiut University Children's Hospital

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.