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Condition / disease
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Status: Not yet recruiting

TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)

This study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed formula in young children aged 1\~3 years with diagnosed with or highly suspected CMPA in a real-world clinical practice setting. The study will also evaluate the growth parameters, stool frequency and consistency, formula intake volume, gastrointestinal tolerance (including fussiness, flatulence, colic) and sleep disturbances, and any adverse events that may arise during the intervention period. This is a prospective, single-arm study including 50 young children at 1 hospital in China. Each participant will be followed for 90 days.

Participants needed: 50
Trial details
Age: 12-36Biological sex: AllType: InterventionalSponsor: Shanghai Teyi Yinuo Health Technology Co., Ltd.Updated: Oct 2, 2026Locations: 1
Eligibility criteria

12 months≤ Age <36 months at enrollment. [+6]

History of severe cows-milk-induced allergic reaction, such as anaphylactic shoc... [+7]