Biolizin to improve functional poor appetite in toddlers 6–36 months

A Parallel-Group, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of a Zinc-Containing Dietary Supplement (Biolizin) in Improving Functional Poor Appetite in Children Aged 6 to 36 Months

This trial will test whether a zinc syrup (Biolizin), given with caregiver responsive-feeding counseling, helps children 6–36 months old who have persistent poor appetite without a medical cause.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 6 Months to 36 Months
• Sex: All
• Sponsor: Haiphong University of Medicine and Pharmacy (Academic / other)
• Locations: 1 site (Haiphong, Hai Phong)
• Trial ID: NCT07153549 on ClinicalTrials.gov

What this trial studies

Children aged 6 to 36 months with functional poor appetite receive age-based dosing of an oral zinc supplement (Biolizin) together with standardized caregiver counseling and are followed for 42 days with clinic visits at Day 0, 7, 21, and 42. Caregivers complete a validated Vietnamese feeding-difficulty scale and the Children's Eating Behaviour Questionnaire at each visit while clinicians record weight/length and review concomitant treatments. Safety is monitored by adverse event reporting and routine labs, with serum zinc measured per protocol when indicated. The primary outcome is the change from baseline to Day 42 in the total score of the validated feeding-difficulty scale; secondary outcomes include CEBQ subscales, WHO growth indices, serum zinc (if obtained), and overall safety.

Who should consider this trial

Good fit: Children 6–36 months with at least two weeks of functional poor appetite (reduced intake, prolonged meals, food refusal or oppositional feeding behaviors) without an identifiable organic cause and with weight above −2 SD are ideal candidates.

Not a fit: Children whose poor appetite is caused by an acute infection, chronic gastrointestinal or metabolic disease, or who have weight below −2 SD are excluded and unlikely to benefit from this intervention alone.

Why it matters

Potential benefit: If successful, the supplement plus caregiver counseling could improve eating behavior and intake in young children with functional poor appetite, potentially supporting healthier growth and easier mealtimes for families.

How similar studies have performed: Previous research indicates zinc supplementation can improve appetite in zinc-deficient or malnourished children, but using a zinc syrup together with standardized responsive-feeding counseling in otherwise healthy toddlers with functional poor appetite is a relatively novel approach.

Eligibility criteria

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 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 Criteria:

* 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 this trial is running

Haiphong, Hai Phong

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

Study contacts

• Study coordinator: Phuong Thi Thu Nguyen, MD, PhD

Conditions Feeding and Eating Disorders of Childhood; Appetite Disorders; Functional Poor Appetite; functional poor appetite; pediatric feeding problems; feeding difficulty; loss of appetite; eating/feeding behavior