Not Yet RecruitingNot Applicable

Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula

Egypt160 participantsStarted 2026-01-01

Plain-language 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.

Who can participate

Age range1 Month – 12 Months

SexALL

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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.

What they're measuring

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

Timeframe: Single assessment at enrollment.

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

Timeframe: Single assessment at enrollment.

Nutritional Status (Weight-for-Age Z-sco

Timeframe: At the time of enrollment (single assessment).

Trial details

NCT IDNCT07174999

SponsorAssiut University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-30

Contact for this trial

Merna Emeel Fahmy, MBBCh, Pediatric Resident

01202626579 Merna.17289584@med.aun.edu.eg

View on ClinicalTrials.gov More Cow's Milk Protein Allergy Protein Intolerance Failure to Thrive trials