Cow Milk Protein AllergyNCT07687797
Partially Hydrolysed Whey Based Formula in Differentiation Between Non IgE Gastrointestinal Cow's Milk Protein Allergy and Milk Intolerance
A study testing partially hydrolysed whey based formula and amino acid based formula in people with Cow Milk Protein Allergy and Cow Milk Intolerance, run by Ain Shams University at 1 site in Egypt.
Trial summary
Partially hydrolysed whey based formula in differentiation between non IgE gastrointestinal cow's milk protein allergy and milk intolerance Read more about this study
- Who is it for?
- Ages 1 month to 6 months
- Conditions the study is for
- Cow Milk Protein Allergy, Cow Milk Intolerance
- What is being tested?
- partially hydrolysed whey based formula and amino acid based formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2026to Dec 2027
- Phase
- Interventional
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-6 months of age
- formula fed infants
- CoMiSS score above 10
- Repeated body mucoid stool
Who cannot join
- IgE mediated disease
- Skin allergy
- Respiratory symptoms
- Exclusive or mixed breast feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medicine Ain Shams University
Cairo, 11566
Fatma Ebeid, 01095569596, dr.fatma_ebeid@yahoo.com
About this study
Partially hydrolysed whey based formula in differentiation between non IgE gastrointestinal cow's milk protein allergy and milk intolerance
- Conditions
- Cow Milk Protein Allergy, Cow Milk Intolerance
- Being tested
- partially hydrolysed whey based formula, amino acid based formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partially hydrolysed whey based formulaDietary supplement
partially hydrolysed whey based formula
amino acid based formulaDietary supplement
classic pathway of cow milk protein intolerance
| Study group | Role | What they receive |
|---|---|---|
| classic algorithm pathway receiving amino acid based formula | Active comparator | study pathway receiving partially hydrolyzed whey based formula Receives: Dietary Supplement: amino acid based formula |
| study pathway receiving partially hydrolyzed whey based formula | Experimental | Not described Receives: Dietary Supplement: partially hydrolysed whey based formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
determining the frequency of cow milk intolerance diagnosis among patients suspected for cow milk protein allergy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk Protein AllergyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Elhodhod, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687797
- Sponsor's protocol ID
- FMASU R115/2026
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partially Hydrolysed Whey Based Formula in Differentiation Between Non IgE Gastrointestinal Cow's Milk Protein Allergy and Milk Intolerance
- ClinicalTrials.gov ID
- NCT07687797
- Acronym / sponsor ID
- FMASU R115/2026
- Conditions
- Cow Milk Protein Allergy, Cow Milk Intolerance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Jul 2026 (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.
Partially hydrolysed whey based formula in differentiation between non IgE gastrointestinal cow's milk protein allergy and milk intolerance
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classic algorithm pathway receiving amino acid based formula | Active comparator | Dietary Supplement: amino acid based formulastudy pathway receiving partially hydrolyzed whey based formula |
| study pathway receiving partially hydrolyzed whey based formula | Experimental | Dietary Supplement: partially hydrolysed whey based formula |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1-6 months of age
- formula fed infants
- CoMiSS score above 10
- Repeated body mucoid stool
Key exclusion criteria (4 listed)
- IgE mediated disease
- Skin allergy
- Respiratory symptoms
- Exclusive or mixed breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| partially hydrolysed whey based formulapartially hydrolysed whey based formula | Dietary supplement | study pathway receiving partially hydrolyzed whey based formula |
| amino acid based formulaclassic pathway of cow milk protein intolerance | Dietary supplement | classic algorithm pathway receiving amino acid based formula |
Primary outcome
determining the frequency of cow milk intolerance diagnosis among patients suspected for cow milk protein allergy
Time frame: 12 weeks
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partially hydrolysed whey based formula and amino acid based formula in people with Cow Milk Protein Allergy and Cow Milk Intolerance, run by Ain Shams 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 4 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 7 Jul 2026. 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 Mostafa Elhodhod (+2010065541445, moshodhod@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determining the frequency of cow milk intolerance diagnosis among patients suspected for cow milk protein allergy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.