Status:
NOT_YET_RECRUITING
Biolizin for Improving Functional Poor Appetite in Children Aged 6 to 36 Months (CTBE2502)
Lead Sponsor:
Haiphong University of Medicine and Pharmacy
Conditions:
Feeding and Eating Disorders of Childhood
Appetite Disorders
Eligibility:
All Genders
6-36 years
Phase:
NA
Brief Summary
Functional poor appetite is common in young children and may be linked to suboptimal micronutrient intake and feeding behavior. This study evaluates whether a zinc-containing oral supplement (Biolizin...
Detailed Description
Poor appetite in toddlers often reflects a combination of nutritional and behavioral factors. Zinc is an essential trace element that contributes to taste perception, mucosal integrity, and appetite r...
Eligibility Criteria
Inclusion
- 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 meals per 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
- Ongoing acute or chronic illnesses that can affect intake or absorption, including but not limited to:
- Acute infections (e.g., tonsillitis, pneumonia, otitis media, viral febrile illness, 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., cerebral palsy, 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 before screening.
- 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 lactose intolerance, 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 for cow's milk protein allergy, severe malnutrition, tube feeding, or individualized nutrition regimens beyond usual diet).
- Nonadherent caregiver or high risk of loss to follow-up as judged by the investigator.
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07153549
Start Date
September 20 2025
End Date
April 30 2026
Last Update
September 4 2025
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