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

Recruiting now · Not applicable

Conditions studied: Feeding and Eating Disorders of Childhood, Appetite Disorders, Functional Poor Appetite

In brief

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 syrup) can improve eating behavior in children aged 6 to 36 months who have poor appetite without an identifiable medical cause. Participants are followed for 42 days with clinic visits at Day 0, Day 7, Day 21, and Day 42. Caregivers complete validated questionnaires about feeding difficulties and eating behavior; the child's weight and length/height are measured at each visit. Safety is assessed through review of adverse events and routine laboratory tests; serum zinc may be measured according to the protocol. The primary outcome is the change from baseline to Day 42 in the total score of a validated feeding-difficulty scale. Secondary outcomes include changes in Children's Eating Behaviour Questionnaire (CEBQ) subscales, WHO growth indices, serum zinc (if measured), and overall safety

Key facts

Study ID

NCT07153549

Run by

Haiphong University of Medicine and Pharmacy

People needed

110

Starts

2025-09-20

Expected to finish

2026-04-30

Last updated by the study team

2026-01-30

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Trial and Bioequivalence Center — Haiphong, Hai Phong, Vietnam (enrolling)

Full record on ClinicalTrials.gov

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