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The mechanism and clinical efficacy of Aunulife in preventing and treating of infant food allergy

The mechanism and clinical efficacy of Aunulife in preventing and treating of infant food allergy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069282
Enrollment
Unknown
Registered
2023-03-12
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant food allergy (FA)

Interventions

Non-CMPA observation group:Diet Avoidance + Small Orange Box (including MP108)
Non-CMPA control group:Diet Avoidance + Placebo
CMPA observation group:eHF+ Small Orange Box (including MP108)
CMPA control group:eHF+ Placebo

Sponsors

Zhuhai Maternal and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 2 Years

Inclusion criteria

Inclusion criteria: 1. Screening of infants suspected of FA: During the study, full-term infants suspected of FA who showed signs and symptoms related to FA for the first time and went to the child health department of the above hospital for treatment were aged no more than 24 months according to the recommendations on the diagnosis and treatment of food allergy and evidence-based guidelines. 2. Screening of infants suspected of CMA: During the study period, full-term infants suspected of CMA who showed signs and symptoms related to CMA for the first time and visited the outpatient department of child care in the above hospital were no more than 24 months old. The assessment of symptoms and signs associated with CMA was based on the Milk Associated Symptom Score (CoMiSS), with CoMiSS >= 10 classified as suspected CMA. 3. Criteria for the diagnosis of FA: Experimental dietary avoidance (EDA) was performed for 2 to 6 weeks, and then experimental dietary avoidance (EDA) OFC was performed for the children with FA diagnosis. 4. Criteria for diagnosis of CMA: Children with suspected CMA were enrolled, who underwent EDA in milk or milk products for 2 to 6 weeks, and then underwent OFC, and those with EDA-OFC positive were confirmed as children with CMA.

Exclusion criteria

Exclusion criteria: 1. Infants with serious diseases of heart, lung, brain and other important organs; 2. Infants with genetic metabolic diseases, chromosomal abnormalities and other congenital diseases; 3. Skin prick test was strongly positive; sIgE is greater than 95% positive predictive value; Deformity; Severe reaction (anaphylaxis); Severe eczema; Moderate to severe malnutrition; Congenital dermatosis; 4. Take probiotics, prebiotics, Biostime, or any deep or amino acid formula 4 weeks before the visit.

Design outcomes

Primary

MeasureTime frame
Immunologic function;Scoring System for Symptoms Associated with Milk Protein (COMISS) Score;

Countries

China

Contacts

Public ContactMa Fei

Zhuhai Maternal and Child Health Care Hospital

mafei5@mail3.sysu.edu.cn+86 15012929438

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026