Actively Recruiting
Biolizin for Improving Functional Poor Appetite in Children Aged 6 to 36 Months (CTBE2502)
Led by Haiphong University of Medicine and Pharmacy · Updated on 2026-01-30
110
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Biolizin for Improving Functional Poor Appetite in Children Aged 6 to 36 Months (CTBE2502)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 to 36 months at screening
- Functional poor appetite lasting at least 2 weeks with one or more of the following: clearly reduced food intake or fewer meals, prolonged meal duration over 30 minutes, refusal or avoidance of familiar foods, oppositional feeding behaviors such as turning away or crying
- No obvious medical cause of poor appetite like acute infection or metabolic disease
- Weight not below -2 standard deviations compared to WHO growth standards
- Parent or guardian provides written informed consent
You will not qualify if you...
- Acute or chronic illnesses affecting food intake or absorption, including infections, celiac disease, chronic liver or kidney disease, diabetes
- Neurodevelopmental or neurological conditions impairing feeding, such as cerebral palsy or autism spectrum disorder
- Current or recent use of medications that alter appetite or digestion, including systemic corticosteroids or antiepileptics
- Use of zinc products or appetite stimulants within 7 days before screening
- Known allergy to any ingredient of the study product
- Malabsorption disorders, severe malnutrition, or need for specialized nutrition plans like therapeutic formulas or tube feeding
- Caregiver not able to follow study procedures or high risk of loss to follow-up
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, Vietnam, 180000
Actively Recruiting
Research Team
P
Phuong Thi Thu Nguyen, MD, PhD
CONTACT
A
Anh Van Tran, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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