Cow's Milk Protein AllergyNCT06130085
Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination
A study testing Partially hydrolyzed formula in people with Cow's Milk Protein Allergy, run by Ain Shams University at 1 site in Egypt.
Trial summary
For Patients diagnosed as cow milk protein allergy: Elimination of cow's milk products (CMPs) for 6 months. All infants were supplemented with Amino Acid-based Formula (AAF) (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet. Read more about this study
- Who is it for?
- Ages 7 months to 3 years
- Conditions the study is for
- Cow's Milk Protein Allergy
- What is being tested?
- Partially hydrolyzed formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Artificially fed infants whether exclusively or complementary.
- Confirmed diagnosis of CMPA based on clinical symptoms and signs and followed by withdrawal open re-challenge test
Who cannot join
- Exclusively breast-fed infants.
- Anaphylactic type.
- Multiple food Allergies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Labeled Randomized Clinical Trial of Introduction of a Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination Protocol
For Patients diagnosed as cow milk protein allergy: Elimination of cow's milk products (CMPs) for 6 months.
All infants were supplemented with Amino Acid-based Formula (AAF) (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet.
Read more
For mixed milk fed infants (still receiving breast milk with the formula), mothers were encouraged to continue breast-feeding while avoiding all milk and milk products from their own diet.
Intervention after completing 6 months of eliminating CMPs. The included patients were randomly assigned to one of (2 groups).
- Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months.
- Group II (pHF group) n= 50 Infants in this group were shifted gradually to Partially-hydrolyzed whey formula (pHF) (Liptomil Plus HA infant formula. for another 6 months with continuation of elimination of cow's milk products.
They were followed up for manifestations of intolerance to pHF. Infant who showed manifestations of intolerance were returned to AAF and continued for 6 months with AAF.
Final step: Reintoduction of CMPs After 12 months of elimination of CMPs, evaluation of tolerance to whole CMPs was done by oral food challenge (OFC).
For infants who were still non-tolerant to CMPs after 12 months of elimination were followed up and re-challenged after 6 months.
Read the detailed description
Phase Ⅰ:Initial assessment at enrollment i. Full medical history taking: with emphasis on: Personal History: Age- Sex- Order of birth- Consanguinity-Residence
Main presenting symptoms:
A- Gastrointestinal symptoms: at initial diagnosis According to the clinical presentations, following clinical diagnoses were identified GERD, FPIAP, FPIES, FPE, constipation and combination of symptoms as shown in the following table.
B- Associated systemic allergic manifestations: at initial diagnosis C- CoMiSS: Cow's Milk-related Symptom Score (CoMiSS) at presentation. CMPA diagnosis was confirmed by an elimination diet followed by an oral food challenge.
D- Course of the disease:
E- Dietary and nutritional history:
- Breast Feeding: If Yes exclusive for how long?
- Artificial feeding: Age of start, type of formula, Indication.
- Weaning: Time of start, Type of food given (each food and time of introduction especially cow's milk and CMPs), Any problems during weaning (gastrointestinal, respiratory or skin allergies) and eliciting dose of milk products that caused symptoms.
- Accidental intake of raw or heated milk during elimination period and its consequences.
- Past history: mode of delivery
- Family history: atopy, siblings with CMPA
- Medication history: Antireflux medications, laxatives, probiotics. ii. Clinical examination:
- Anthropometric measurements: (weight \&height on Z score, Wt/Ht ratio) using WHO 2006 Growth charts to those aged ≤ 2 years \& CDC Growth charts 2000 if >2 years old
- Signs of allergy: (atopic dermatitis- allergic rhinitis-wheezy chest)
- Abdomen:(Distension- Tenderness- organomegaly)
- Perineal area: (Perianal inflammation, napkin rash)
Phase 2: Elimination of CMPs for 6 months. All infants were supplemented with Amino Acid-based Formula (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet. Cow's-milk-based formula and supplementary foods containing CMPs, other animal milk proteins (eg, goat's milk, sheep's milk) were strictly avoided due to cross reactivity.
For mixed milk fed infants (still receiving breast milk with the formula), mothers were encouraged to continue breast-feeding while avoiding all milk and milk products from their own diet Breast feeding mothers excluding cow's milk were prescribed a supplement of 1000 mg of calcium \& 10 µg (400 IU) of vitamin D every day
Phase III: Intervention after completing 6 months of eliminating CMPs
- The included patients were randomly assigned to one of (2 groups).
- Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months.
- Group II (pHF group) n= 50 Infants in this group were shifted gradually the same way as OFC (from Amino Acid-based Formula; to Partially-hydrolyzed whey formula (Liptomil Plus HA infant formula; for another 6 months with continuation of elimination of CMPs.
They were followed up for manifestations of intolerance to pHF. Infant who showed manifestations of intolerance were returned to AAF and continued for 6 months with AAF.
Phase IV: Reintroduction of CMPs After 12 months of elimination of CMPs, evaluation of tolerance to whole CMPs was done by OFC. Tolerance was established by a negative challenge followed by regular ingestion of age-appropriate quantities of cow's milk at home without symptoms, where patients were followed up again for one month to detect any symptoms of intolerance after regular ingestion of milk products
For infants who were still non-tolerant to CMPs after 12 months of elimination were followed up and re-challenged after 6 months.
- Conditions
- Cow's Milk Protein Allergy
- Being tested
- Partially hydrolyzed formula
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially hydrolyzed formulaDietary supplement
Partially hydrolyzed formula given as the milk supplement for cow milk allergy patients after 6 months of strict elimination diet
| Study group | Role | What they receive |
|---|---|---|
| Infants Continuing on amino acid based formula after 6 months elimination | No intervention | Not described |
| Infants receiving partially hydrolyzed formula after 6 months of elimination diet | Active comparator | Not described Receives: Dietary Supplement: Partially hydrolyzed formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the rate of tolerance to cow milk products among patients allocated to partially hydrolyzed formula after 6 months of milk free diet compared to those who completed 1 year of elimination
Questionnaire done to assess occurrence of following symptoms Vomiting, Hematemesis, Diarrhea (using BRISTOL scale), Constipation, Eczema, Skin rash, Perianal inflammation, weight loss in kilograms or failure to gain weight in kilograms, (Colic, Straining and marked Abdominal distension), skin rash, angioedema, and recurrent respiratory symptoms within two months of following up after milk reintroduction. If any of the previous items is present, then the patient is considered intolerant to milk. All items should be answered by (no) in order to consider the patient tolerant to milk
Measured: At the month 13 for both groups and for extra more 30 days of regular ingestion of cow's milk products
Secondary outcomes (1)
Tolerance to pHF after 6 months elimination diet
To assess tolerance to partially hydrolsed milk formula in the group assigned to ingest pHF via a Questionnaire done to assess occurrence of following symptoms Vomiting, Hematemesis, Diarrhea (using BRISTOL scale), Constipation, Eczema, Skin rash, Perianal inflammation, weight loss in kilograms or failure to gain weight in kilograms, (Colic, Straining and marked Abdominal distension), skin rash, angioedema, and recurrent respiratory symptoms within two months of following up after milk reintroduction. If any of the previous items is present, then the patient is considered intolerant to milk. All items should be answered by (no) in order to consider the patient tolerant to pHF.
Measured: At the seventh month in the group allocated to receive pHF after six months of elimination diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start15 Jan 2024
- Primary completion15 Jan 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cow's Milk Protein AllergyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130085
- Sponsor's protocol ID
- MD444/2017
- Status last verified
- Apr 2025
- First submitted
- 15 Jul 2023
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vandenplas Y, Dupont C, Eigenmann P, Host A, Kuitunen M, Ribes-Koninckx C, Shah N, Shamir R, Staiano A, Szajewska H, Von Berg A. A workshop report on the development of the Cow's Milk-related Symptom Score awareness tool for young children. Acta Paediatr. 2015 Apr;104(4):334-9. doi: 10.1111/apa.12902. Epub 2015 Jan 29.
PubMed 25557474Nowak-Wegrzyn A, Chehade M, Groetch ME, Spergel JM, Wood RA, Allen K, Atkins D, Bahna S, Barad AV, Berin C, Brown Whitehorn T, Burks AW, Caubet JC, Cianferoni A, Conte M, Davis C, Fiocchi A, Grimshaw K, Gupta R, Hofmeister B, Hwang JB, Katz Y, Konstantinou GN, Leonard SA, Lightdale J, McGhee S, Mehr S, Sopo SM, Monti G, Muraro A, Noel SK, Nomura I, Noone S, Sampson HA, Schultz F, Sicherer SH, Thompson CC, Turner PJ, Venter C, Westcott-Chavez AA, Greenhawt M. International consensus guidelines for the diagnosis and management of food protein-induced enterocolitis syndrome: Executive summary-Workgroup Report of the Adverse Reactions to Foods Committee, American Academy of Allergy, Asthma & Immunology. J Allergy Clin Immunol. 2017 Apr;139(4):1111-1126.e4. doi: 10.1016/j.jaci.2016.12.966. Epub 2017 Feb 4.
PubMed 28167094Mehta NM, Corkins MR, Lyman B, Malone A, Goday PS, Carney LN, Monczka JL, Plogsted SW, Schwenk WF; American Society for Parenteral and Enteral Nutrition Board of Directors. Defining pediatric malnutrition: a paradigm shift toward etiology-related definitions. JPEN J Parenter Enteral Nutr. 2013 Jul;37(4):460-81. doi: 10.1177/0148607113479972. Epub 2013 Mar 25.
PubMed 23528324Luyt D, Ball H, Makwana N, Green MR, Bravin K, Nasser SM, Clark AT; Standards of Care Committee (SOCC) of the British Society for Allergy and Clinical Immunology (BSACI). BSACI guideline for the diagnosis and management of cow's milk allergy. Clin Exp Allergy. 2014;44(5):642-72. doi: 10.1111/cea.12302.
PubMed 24588904Ludman S, Shah N, Fox AT. Managing cows' milk allergy in children. BMJ. 2013 Sep 16;347:f5424. doi: 10.1136/bmj.f5424. No abstract available.
PubMed 24041704Lightdale JR, Gremse DA; Section on Gastroenterology, Hepatology, and Nutrition. Gastroesophageal reflux: management guidance for the pediatrician. Pediatrics. 2013 May;131(5):e1684-95. doi: 10.1542/peds.2013-0421. Epub 2013 Apr 29.
PubMed 23629618
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Labeled Randomized Clinical Trial of Introduction of a Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination Protocol
- ClinicalTrials.gov ID
- NCT06130085
- Acronym / sponsor ID
- MD444/2017
- Conditions
- Cow's Milk Protein Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 13 Nov 2023 (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.
For Patients diagnosed as cow milk protein allergy: Elimination of cow's milk products (CMPs) for 6 months.
All infants were supplemented with Amino Acid-based Formula (AAF) (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet.
For mixed milk fed infants (still receiving breast milk with the formula), mothers were encouraged to continue breast-feeding while avoiding all milk and milk products from their own diet.
Intervention after completing 6 months of eliminating CMPs. The included patients were randomly assigned to one of (2 groups).
- Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months.
- Group II (pHF group) n= 50 Infants in this group were shifted gradually to Partially-hydrolyzed whey formula (pHF) (Liptomil Plus HA infant formula. for another 6 months with continuation of elimination of cow's milk products.
They were followed up for manifestations of intolerance to pHF. Infant who showed manifestations of intolerance were returned to AAF and continued for 6 months with AAF.
Final step: Reintoduction of CMPs After 12 months of elimination of CMPs, evaluation of tolerance to whole CMPs was done by oral food challenge (OFC).
For infants who were still non-tolerant to CMPs after 12 months of elimination were followed up and re-challenged after 6 months.
Detailed description
Phase Ⅰ:Initial assessment at enrollment i. Full medical history taking: with emphasis on: Personal History: Age- Sex- Order of birth- Consanguinity-Residence
Main presenting symptoms:
A- Gastrointestinal symptoms: at initial diagnosis According to the clinical presentations, following clinical diagnoses were identified GERD, FPIAP, FPIES, FPE, constipation and combination of symptoms as shown in the following table.
B- Associated systemic allergic manifestations: at initial diagnosis C- CoMiSS: Cow's Milk-related Symptom Score (CoMiSS) at presentation. CMPA diagnosis was confirmed by an elimination diet followed by an oral food challenge.
D- Course of the disease:
E- Dietary and nutritional history:
- Breast Feeding: If Yes exclusive for how long?
- Artificial feeding: Age of start, type of formula, Indication.
- Weaning: Time of start, Type of food given (each food and time of introduction especially cow's milk and CMPs), Any problems during weaning (gastrointestinal, respiratory or skin allergies) and eliciting dose of milk products that caused symptoms.
- Accidental intake of raw or heated milk during elimination period and its consequences.
- Past history: mode of delivery
- Family history: atopy, siblings with CMPA
- Medication history: Antireflux medications, laxatives, probiotics. ii. Clinical examination:
- Anthropometric measurements: (weight \&height on Z score, Wt/Ht ratio) using WHO 2006 Growth charts to those aged ≤ 2 years \& CDC Growth charts 2000 if >2 years old
- Signs of allergy: (atopic dermatitis- allergic rhinitis-wheezy chest)
- Abdomen:(Distension- Tenderness- organomegaly)
- Perineal area: (Perianal inflammation, napkin rash)
Phase 2: Elimination of CMPs for 6 months. All infants were supplemented with Amino Acid-based Formula (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet. Cow's-milk-based formula and supplementary foods containing CMPs, other animal milk proteins (eg, goat's milk, sheep's milk) were strictly avoided due to cross reactivity.
For mixed milk fed infants (still receiving breast milk with the formula), mothers were encouraged to continue breast-feeding while avoiding all milk and milk products from their own diet Breast feeding mothers excluding cow's milk were prescribed a supplement of 1000 mg of calcium \& 10 µg (400 IU) of vitamin D every day
Phase III: Intervention after completing 6 months of eliminating CMPs
- The included patients were randomly assigned to one of (2 groups).
- Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months.
- Group II (pHF group) n= 50 Infants in this group were shifted gradually the same way as OFC (from Amino Acid-based Formula; to Partially-hydrolyzed whey formula (Liptomil Plus HA infant formula; for another 6 months with continuation of elimination of CMPs.
They were followed up for manifestations of intolerance to pHF. Infant who showed manifestations of intolerance were returned to AAF and continued for 6 months with AAF.
Phase IV: Reintroduction of CMPs After 12 months of elimination of CMPs, evaluation of tolerance to whole CMPs was done by OFC. Tolerance was established by a negative challenge followed by regular ingestion of age-appropriate quantities of cow's milk at home without symptoms, where patients were followed up again for one month to detect any symptoms of intolerance after regular ingestion of milk products
For infants who were still non-tolerant to CMPs after 12 months of elimination were followed up and re-challenged after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants Continuing on amino acid based formula after 6 months elimination | No intervention | – |
| Infants receiving partially hydrolyzed formula after 6 months of elimination diet | Active comparator | Dietary Supplement: Partially hydrolyzed formula |
Who may qualify
- Ages
- 7 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Artificially fed infants whether exclusively or complementary.
- Confirmed diagnosis of CMPA based on clinical symptoms and signs and followed by withdrawal open re-challenge test
Key exclusion criteria (3 listed)
- Exclusively breast-fed infants.
- Anaphylactic type.
- Multiple food Allergies.
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 hydrolyzed formulaPartially hydrolyzed formula given as the milk supplement for cow milk allergy patients after 6 months of strict elimination diet | Dietary supplement | Infants receiving partially hydrolyzed formula after 6 months of elimination diet |
Primary outcome
compare the rate of tolerance to cow milk products among patients allocated to partially hydrolyzed formula after 6 months of milk free diet compared to those who completed 1 year of elimination
Time frame: At the month 13 for both groups and for extra more 30 days of regular ingestion of cow's milk products
Questionnaire done to assess occurrence of following symptoms Vomiting, Hematemesis, Diarrhea (using BRISTOL scale), Constipation, Eczema, Skin rash, Perianal inflammation, weight loss in kilograms or failure to gain weight in kilograms, (Colic, Straining and marked Abdominal distension), skin rash, angioedema, and recurrent respiratory symptoms within two months of following up after milk reintroduction. If any of the previous items is present, then the patient is considered intolerant to milk. All items should be answered by (no) in order to consider the patient tolerant to milk
1 secondary outcome
Tolerance to pHF after 6 months elimination diet
Time frame: At the seventh month in the group allocated to receive pHF after six months of elimination diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Background: PubMed 25557474Vandenplas Y, Dupont C, Eigenmann P, Host A, Kuitunen M, Ribes-Koninckx C, Shah N, Shamir R, Staiano A, Szajewska H, Von Berg A. A workshop report on the development of the Cow's Milk-related Symptom Score awareness tool for young children. Acta Paediatr. 2015 Apr;104(4):334-9. doi: 10.1111/apa.12902. Epub 2015 Jan 29.
- Background: PubMed 28167094Nowak-Wegrzyn A, Chehade M, Groetch ME, Spergel JM, Wood RA, Allen K, Atkins D, Bahna S, Barad AV, Berin C, Brown Whitehorn T, Burks AW, Caubet JC, Cianferoni A, Conte M, Davis C, Fiocchi A, Grimshaw K, Gupta R, Hofmeister B, Hwang JB, Katz Y, Konstantinou GN, Leonard SA, Lightdale J, McGhee S, Mehr S, Sopo SM, Monti G, Muraro A, Noel SK, Nomura I, Noone S, Sampson HA, Schultz F, Sicherer SH, Thompson CC, Turner PJ, Venter C, Westcott-Chavez AA, Greenhawt M. International consensus guidelines for the diagnosis and management of food protein-induced enterocolitis syndrome: Executive summary-Workgroup Report of the Adverse Reactions to Foods Committee, American Academy of Allergy, Asthma & Immunology. J Allergy Clin Immunol. 2017 Apr;139(4):1111-1126.e4. doi: 10.1016/j.jaci.2016.12.966. Epub 2017 Feb 4.
- Background: PubMed 23528324Mehta NM, Corkins MR, Lyman B, Malone A, Goday PS, Carney LN, Monczka JL, Plogsted SW, Schwenk WF; American Society for Parenteral and Enteral Nutrition Board of Directors. Defining pediatric malnutrition: a paradigm shift toward etiology-related definitions. JPEN J Parenter Enteral Nutr. 2013 Jul;37(4):460-81. doi: 10.1177/0148607113479972. Epub 2013 Mar 25.
- Background: PubMed 24588904Luyt D, Ball H, Makwana N, Green MR, Bravin K, Nasser SM, Clark AT; Standards of Care Committee (SOCC) of the British Society for Allergy and Clinical Immunology (BSACI). BSACI guideline for the diagnosis and management of cow's milk allergy. Clin Exp Allergy. 2014;44(5):642-72. doi: 10.1111/cea.12302.
- Background: PubMed 24041704Ludman S, Shah N, Fox AT. Managing cows' milk allergy in children. BMJ. 2013 Sep 16;347:f5424. doi: 10.1136/bmj.f5424. No abstract available.
- Background: PubMed 23629618Lightdale JR, Gremse DA; Section on Gastroenterology, Hepatology, and Nutrition. Gastroesophageal reflux: management guidance for the pediatrician. Pediatrics. 2013 May;131(5):e1684-95. doi: 10.1542/peds.2013-0421. Epub 2013 Apr 29.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 hydrolyzed formula in people with Cow's Milk Protein Allergy, 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 7 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the rate of tolerance to cow milk products among patients allocated to partially hydrolyzed formula after 6 months of milk free diet compared to those who completed 1 year of elimination (time frame: At the month 13 for both groups and for extra more 30 days of regular ingestion of cow's milk products). 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 NCT06130085, which also lists 6 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 7 May 2025.