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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Phuong Thi Thu Nguyen, MD, PhD
• Email: nttphuong@hpmu.edu.vn
• Phone: +84936685007

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.