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Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 1 Month - 12 Months
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07174999
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assiut University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rehab Ibrahim Hassan, profOsama Mahmoud Elasheer, prof
Principal Investigator Affiliation Assiut UniversityAssiut University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Egypt
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cow's Milk Protein Allergy Protein Intolerance Failure to Thrive
Additional Details

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.

Arms & Interventions

Arms

: Study Population

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

Interventions

Contact a Trial Team

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International Sites

Assiut University, Asyut 359783, Egypt

Status

Address

Assiut University

Asyut 359783, ,

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