Cow's Milk Protein Allergy Protein Intolerance Failure to ThriveNCT07174999
Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula
An observational study of Cow's Milk Protein Allergy Protein Intolerance Failure to Thrive, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Cow's Milk Protein Allergy Protein Intolerance Failure to Thrive
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: The study population will include infants aged 1 to 12 months who are exclusively or predominantly receiving amino acid-based formula (AAF) as part of their routine medical care due to established clinical indications.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Observational Study for Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula at Assiut University Children's Hospital
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.
Read the detailed 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.
- Keywords
- Amino Acid-Based Formula Infant Nutrition Growth Assessment Food Allergy Nutritional Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Infants receiving amino acid-based formula who are evaluated at the Nutrition and Gastroenterology Departments, Assiut University Children's Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean anthropometric z-scores (WAZ, LAZ, WLZ)
Mean weight-for-age, length-for-age, and weight-for-length z-scores for the study population compared to WHO reference.
Measured: Single assessment at enrollment.
Weight-for-Age Z-score (WAZ) - prevalence of underweight
Prevalence of underweight (weight-for-age z-score < -2) among infants receiving amino acid-based formula, calculated according to WHO growth standards.
Measured: Single assessment at enrollment.
Nutritional Status (Weight-for-Age Z-sco
Assessment of weight-for-age z-score in infants receiving amino acid-based formula compared to WHO growth standards.
Measured: At the time of enrollment (single assessment).
Secondary outcomes (3)
Length-for-Age Z-score
Measurement of length-for-age z-score according to WHO growth standards.
Measured: At the time of enrollment.
Head Circumference-for-Age Z-score
Measurement of head circumference-for-age z-score according to WHO growth standards.
Measured: At the time of enrollment.
Gastrointestinal Symptoms
Assessment of gastrointestinal tolerance including vomiting, diarrhea, and constipation
Measured: At the time of enrollment (parental report).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cow's Milk Protein Allergy Protein Intolerance Failure to ThriveStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Emeel Fahmy Abd Elmalak, Assiut University
- Investigators
- Rehab Ibrahim Hassan, prof, Principal investigator, Assiut UniversityOsama Mahmoud Elasheer, prof, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174999
- Sponsor's protocol ID
- AA-Formula-Study-2025
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fiocchi A, Brozek J, Schunemann H, Bahna SL, von Berg A, Beyer K, Bozzola M, Bradsher J, Compalati E, Ebisawa M, Guzman MA, Li H, Heine RG, Keith P, Lack G, Landi M, Martelli A, Rance F, Sampson H, Stein A, Terracciano L, Vieths S. World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) Guidelines. World Allergy Organ J. 2010 Apr;3(4):57-161. doi: 10.1097/WOX.0b013e3181defeb9. Epub 2010 Apr 23. No abstract available.
PubMed 23268426Koletzko S, Niggemann B, Arato A, Dias JA, Heuschkel R, Husby S, Mearin ML, Papadopoulou A, Ruemmele FM, Staiano A, Schappi MG, Vandenplas Y; European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Diagnostic approach and management of cow's-milk protein allergy in infants and children: ESPGHAN GI Committee practical guidelines. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):221-9. doi: 10.1097/MPG.0b013e31825c9482.
PubMed 22569527
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study for Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula at Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT07174999
- Acronym / sponsor ID
- AA-Formula-Study-2025
- Keywords
- Amino Acid-Based Formula Infant Nutrition Growth Assessment Food Allergy Nutritional Evaluation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | –Infants receiving amino acid-based formula who are evaluated at the Nutrition and Gastroenterology Departments, Assiut University Children's Hospital. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will include infants aged 1 to 12 months who are exclusively or predominantly receiving amino acid-based formula (AAF) as part of their routine medical care due to established clinical indications.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
3 secondary outcomes
Length-for-Age Z-score
Time frame: At the time of enrollment.
Head Circumference-for-Age Z-score
Time frame: At the time of enrollment.
Gastrointestinal Symptoms
Time frame: At the time of enrollment (parental report).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Results publication: PubMed 23268426Fiocchi A, Brozek J, Schunemann H, Bahna SL, von Berg A, Beyer K, Bozzola M, Bradsher J, Compalati E, Ebisawa M, Guzman MA, Li H, Heine RG, Keith P, Lack G, Landi M, Martelli A, Rance F, Sampson H, Stein A, Terracciano L, Vieths S. World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) Guidelines. World Allergy Organ J. 2010 Apr;3(4):57-161. doi: 10.1097/WOX.0b013e3181defeb9. Epub 2010 Apr 23. No abstract available.
- Results publication: PubMed 22569527Koletzko S, Niggemann B, Arato A, Dias JA, Heuschkel R, Husby S, Mearin ML, Papadopoulou A, Ruemmele FM, Staiano A, Schappi MG, Vandenplas Y; European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Diagnostic approach and management of cow's-milk protein allergy in infants and children: ESPGHAN GI Committee practical guidelines. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):221-9. doi: 10.1097/MPG.0b013e31825c9482.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rehab Ibrahim Hassan, prof principal investigator
Assiut University
Osama Mahmoud Elasheer, prof principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow's Milk Protein Allergy Protein Intolerance Failure to Thrive, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merna Emeel Fahmy, MBBCh, Pediatric Resident (01202626579, Merna.17289584@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean anthropometric z-scores (WAZ, LAZ, WLZ) (time frame: Single assessment at enrollment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07174999, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.