Dietary Restriction Efficiency Assessment in CMPA

NCT07199023 | Not Yet Recruiting

• 1 other identifier: DREAM-CHINA
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cow's Milk Protein Allergy

Keywords

Amino Acid Formula; Extended Hydrolyzed Formula; Cow's milk protein allergy

Outcome Measures

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.

  2 weeks after enrolled

Secondary Outcomes (1)

• The number of days it takes for the child to achieve significant improvement in symptoms

  2 weeks after enrolled

Other Outcomes (2)

• CMPA diagnosis rate (OFC positive rate)

  2 weeks after enrolled

• Sensitivity and validity of CMPA score

  2 weeks after enrolled

Study Arms (2)

Amino Acid Formula Group (AAF Group)

ACTIVE COMPARATOR

Participants in this group will receive an amino acid-based formula (AAF) for at least 2 weeks during the elimination diet phase. If symptoms improve, participants will undergo an oral food challenge (OFC) to confirm the diagnosis of cow's milk protein allergy (CMPA). If symptoms do not improve after 4 weeks, CMPA will be ruled out.

Dietary Supplement: Amino Acid Formula (AAF)

Extensively Hydrolyzed Formula Group (eHF Group)

EXPERIMENTAL

Participants in this group will receive an extensively hydrolyzed formula (eHF) for at least 2 weeks during the elimination diet phase. If symptoms improve, OFC will be conducted to confirm CMPA diagnosis. If no improvement is observed, participants may switch to AAF for another 2 weeks of intervention.

Dietary Supplement: Extensively Hydrolyzed Formula (eHF)

Interventions

Amino Acid Formula (AAF) DIETARY_SUPPLEMENT

A 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).

Amino Acid Formula Group (AAF Group)

Extensively Hydrolyzed Formula (eHF) DIETARY_SUPPLEMENT

A 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).

Extensively Hydrolyzed Formula Group (eHF Group)

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 0-6 months; Diagnosed with suspected CMPA at the time of presentation; Artificially or mixed-feeding; Parents willing to sign a written informed consent and comply with the study protocol.

You may not qualify if:

• Infants currently receiving eHF or AAF formula; Mixed-feeding infants whose current daily formula intake is less than 50% of their total milk intake or less than 200 ml; Infants who have already started adding complementary foods; Infants who have experienced severe food allergy symptoms such as shock, severe vomiting, etc. after taking cow's milk protein; Infants with clinical manifestations of systemic allergic reaction or respiratory difficulties such as acute laryngeal edema or bronchial obstruction; Infants who have used prednisolone or anti-allergic drugs in the past 2 weeks; Infants with contraindications to eHF or AAF formula; Infants whose parents are unable to fully report the occurrence of possible symptoms (e.g., insufficient language skills); Infants with other serious diseases, including but not limited to growth retardation, metabolic disorders, kidney disease, congenital heart disease, medical conditions requiring hospitalization for more than 2 weeks, etc.; Infants whose mothers are unable to avoid necessary foods when mixed-feeding.

Sponsors & Collaborators

• Ruijin Hospital: lead
• 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

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Chundi Xu

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chundi Xu

CONTACT

600905 0086-021-64370045; chundixu55@163.com

Xinqiong Wang

CONTACT

wangxq1983@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either an amino acid formula (AAF) or an extensively hydrolyzed formula (eHF) during the diagnostic elimination diet phase. Both groups will follow at least 2 weeks of formula-based feeding. Infants in the eHF group who do not show symptom improvement may switch to AAF for another 2 weeks. Symptom improvement will be evaluated to determine eligibility for an oral food challenge (OFC) to confirm the diagnosis of cow's milk protein allergy (CMPA).

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-08