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RECRUITING

NCT07153549

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

Sponsor: Haiphong University of Medicine and Pharmacy

View on ClinicalTrials.gov

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 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

Official title: 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

Key Details

Gender

All

Age Range

6 Months - 36 Months

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2025-09-20

Completion Date

2026-04-30

Last Updated

2026-01-30

Healthy Volunteers

Conditions

Feeding and Eating Disorders of Childhood Appetite Disorders Functional Poor Appetite

Interventions

DIETARY_SUPPLEMENT

Biolizin

Oral zinc-containing syrup taken per age-based dosing specified in the protocol, once or twice daily for 42 consecutive days. Product is dispensed at baseline (with refill if needed); batch and expiry are recorded. Caregivers receive instructions for use and complete dosing diaries; adherence is checked by diary review and returned bottle counts. Concomitant zinc products or pharmacologic appetite stimulants are not allowed. Safety is monitored through adverse event review and routine laboratory tests at baseline and Day 42.

BEHAVIORAL

Standardized caregiver counseling on responsive feeding

Structured counseling delivered to caregivers at each clinic visit (Day 0, Day 7, Day 21, Day 42). Content includes mealtime routines, recognizing hunger/satiety cues, age-appropriate portions and textures, repeated exposure to diverse foods, and strategies to manage refusal or prolonged meals. A brief checklist guides delivery to ensure consistency across visits. No dietary supplement is provided in this intervention.

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.

Locations (1)

Clinical Trial and Bioequivalence Center

Haiphong, Hai Phong, Vietnam