Skip to content

A Multicenter Prospective Cohort Study using Spoonfulone Among High-Risk Infants for Food Allergy

A Multicenter Prospective Cohort Study using Spoonfulone Among High-Risk Infants for Food Allergy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200065215
Enrollment
Unknown
Registered
2022-10-31
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Food allergy

Interventions

SpoonfulONE group:None

Sponsors

Jinan Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.4 Years to 0.5 Years

Inclusion criteria

Inclusion criteria: 1)Infants at risk for allergies screened by the allergy risk scale; 2)Between 4 and 6 months of age; 3)Complementary foods have not been added; 4)Premature (corrected for age) or full-term; 5)Family informed and signed the consent form.

Exclusion criteria

Exclusion criteria: 1) Congenital malformation; 2)Severe organ disease; 3)Immune diseases, hematological diseases, rickets, neurological diseases, severe infection, malignancies, etc.; 4)Currently under treatment with immunosuppressive drugs, antihistamines, and glucocorticoids; 5)Gastro-oesophageal reflux disease (GERD); 6)Active eczema within two weeks or a history of moderate to severe eczema.

Design outcomes

Primary

MeasureTime frame
Tolerance to predefined food groups of interest including egg, milk, cod, sesame, shellfish, wheat, soy, peanut, tree nuts;Report of food allergy;

Secondary

MeasureTime frame
Survey of basic information of the infant;Survey of the intake information;Survey of Infant feeding and supplementation of complementary foods;Survey of the quality of life;Survey of a symptom within 2 hours of SpoonfulONE intake;Examination and development evaluation;Survey of parental stress index;

Countries

China

Contacts

Public ContactDongmei Zhao

Jinan Children's Hospital

jnzhaodongmei@163.com+86 13625419190

Outcome results

None listed

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