Biolizin for Improving Functional Poor Appetite in Children Aged 6 to 36 Months (CTBE2502)

Inclusion Criteria:

• Age 6 to 36 months at screening.

• Functional poor appetite for ≥2 weeks with at least one of the following:

• Clearly reduced intake versus usual (lower amount of food and/or fewer mealsper day);

• Prolonged meal duration (>30 minutes per meal);

• Refusal or avoidance of familiar foods previously accepted;

• Oppositional feeding behaviors (turning away, crying, gagging/retching,prolonged food holding, lack of cooperation during meals).

• No obvious organic cause of poor appetite (e.g., acute infection,gastrointestinal/metabolic disease).

• Weight not below -2 SD compared with WHO growth standards.

• Parent/guardian provides written informed consent.

Exclusion Criteria:

• Ongoing acute or chronic illnesses that can affect intake or absorption, includingbut not limited to:

• Acute infections (e.g., tonsillitis, pneumonia, otitis media, viral febrileillness, acute diarrhea);

• Chronic conditions affecting digestion or metabolism (e.g., celiac disease,malabsorption syndromes, chronic liver disease, chronic kidney disease,diabetes).

• Neurodevelopmental or neurological conditions that impair feeding (e.g., cerebralpalsy, autism spectrum disorder, global developmental delay).

• Current or recent use of medications known to alter appetite or digestion/absorption (e.g., systemic corticosteroids, antiepileptics, prolonged antibiotics).

• Use of zinc-containing products or other appetite stimulants within 7 days beforescreening.

• Known hypersensitivity to any component of the study product.

• Malabsorption, severe malnutrition, or requirement for specialized nutrition,including:

• Confirmed or suspected malabsorption (e.g., celiac disease, severe lactoseintolerance, short bowel syndrome, inflammatory bowel disease);

• Severe malnutrition per WHO criteria (e.g., weight-for-length Z-score < -3 SD,nutritional edema, marked loss of subcutaneous fat/muscle);

• Physician-prescribed specialized nutrition plans (therapeutic formulas forcow's milk protein allergy, severe malnutrition, tube feeding, orindividualized nutrition regimens beyond usual diet).

• Nonadherent caregiver or high risk of loss to follow-up as judged by theinvestigator.