Dietary Restriction Efficiency Assessment in CMPA

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

Interventions

DIETARY_SUPPLEMENT

Amino Acid Formula (AAF)

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).

DIETARY_SUPPLEMENT

Extensively Hydrolyzed Formula (eHF)

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).

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center

  collaborator OTHER

• Beijing Children's Hospital

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Chengdu Women's and Children's Central Hospital

  collaborator OTHER

• Guiyang Maternity and Child Health Care Hospital

  collaborator OTHER

• Ruijin Hospital

  lead OTHER

Principal Investigators

• Chundi Xu · Ruijin Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Months

Max Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2027-12-31

Completion

2027-12-31