Dietary Restriction Efficiency Assessment in CMPA
ConditionCow's Milk Protein Allergy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-6
SponsorRuijin Hospital
About this trial
This clinical trial aims to evaluate and compare the efficacy of amino acid formula (AAF) and extensively hydrolyzed formula (eHF) in relieving symptoms in infants suspected of cow's milk protein allergy (CMPA) during the diagnostic elimination diet phase. The study will also assess treatment compliance, economic costs, and develop a CMPA screening score suitable for Chinese infants.
Eligible infants (0-6 months old) will be randomized to receive either AAF or eHF for at least 2 weeks. Symptom improvement will be evaluated, followed by an oral food challenge (OFC) to confirm CMPA diagnosis. Infants in the eHF group who do not improve may switch to AAF for further evaluation. The total duration of participation is approximately 6 to 8 weeks.
The study aims to provide evidence-based data to optimize diagnostic pathways and improve quality of life for infants with CMPA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Amino Acid Formula (AAF)
Dietary supplementA formula composed of 100% free amino acids with no intact cow's milk protein. Participants will be fed AAF ad libitum according to their nutritional needs. Daily intake and symptoms will be recorded through an electronic diary (eCOA).
Extensively Hydrolyzed Formula (eHF)
Dietary supplementA formula in which cow's milk proteins are broken down into small peptides through enzymatic hydrolysis, reducing allergenicity. Participants will be fed eHF ad libitum based on their nutritional needs. Intake and symptoms will be tracked through an electronic diary (eCOA).
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Amino Acid Formula Group (AAF Group)Active comparator 1 intervention
Group B: Extensively Hydrolyzed Formula Group (eHF Group)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The percentage of patients with significantly improved symptoms after EDA in the two groups
The criteria for improvement are: * A ≥50% reduction in the Diarrhea and Blood Stool Score. ② A ≥50% reduction in the CoMiSS Score. ③ Marked improvement or resolution of original gastrointestinal and skin symptoms, such as spit-up, vomiting, diarrhea, abdominal distension, abdominal pain, and reflux.
Time frame
2 weeks after enrolledSecondary outcomes
1
The number of days it takes for the child to achieve significant improvement in symptoms
The number of days from the start of the intervention until the child first meets the aforementioned 'marked symptom improvement' criteria.
Time frame
2 weeks after enrolledOther outcomes
1
CMPA diagnosis rate (OFC positive rate)
The proportion of cases with positive EDA results and positive OFC
Time frame
2 weeks after enrolled2
Sensitivity and validity of CMPA score
Compare the diagnostic performance of the CMPA scores in OFC-positive and OFC-negative groups.
Time frame
2 weeks after enrolledLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ruijin Hospital
Lead sponsor
Guangzhou Women and Children's Medical Center
Collaborator
Beijing Children's Hospital
Collaborator
Peking University Third Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Chengdu Women's and Children's Central Hospital
Collaborator
Guiyang Maternity and Child Health Care Hospital
Collaborator
Source ClinicalTrials.gov
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