Biolizin for Improving Functional Poor Appetite in Children Aged 6 to 36 Months (CTBE2502)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-36
SponsorHaiphong University of Medicine and Pharmacy
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 6 to 36 months at screening.
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;
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Biolizin
Dietary supplementOral 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.
Standardized caregiver counseling on responsive feeding
BehavioralStructured 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Biolizin Syrup + Standardized Caregiver CounselingExperimental treatment 2 interventions
Group B: Counseling Only (Standardized Feeding-Behavior Counseling)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Children's Eating Behaviour Questionnaire (CEBQ) Composite Total Score from Baseline to Day 42
The CEBQ is a validated parent-reported questionnaire assessing eating behaviors in children. Each item is scored from 1 (never) to 5 (always). The composite total score is derived from multiple domains (range: 1-5). Higher scores indicate more adverse eating behaviors (worse outcome). A negative change (Day 42 - Baseline \< 0) indicates improvement.
Time frame
Baseline to Day 422
Change in Children's Eating Behaviour Questionnaire (CEBQ) Food Approach Behaviors from Baseline to Day 42
The Children's Eating Behaviour Questionnaire (CEBQ) is a validated parent-reported questionnaire assessing eating behaviors in children. The "food approach" score is the mean of four subscales: Enjoyment of Food, Food Responsiveness, Emotional Overeating, and Desire to Drink. Each item is scored from 1 (never) to 5 (always). Subscale scores range from 1-5, with higher values indicating greater food approach behaviors (worse outcome). A negative change indicates improvement.
Time frame
Baseline to Day 423
Change in Children's Eating Behaviour Questionnaire (CEBQ) Food Avoidant Behaviors from Baseline to Day 42
Mean change in Children's Eating Behaviour Questionnaire (CEBQ) "food avoidant" subscales (Satiety Responsiveness, Slowness in Eating, Food Fussiness, Emotional Undereating). Lower scores indicate less avoidance; negative change denotes improvement.
Time frame
Baseline to Day 424
Responder Rate on Children's Eating Behaviour Questionnaire (CEBQ) (≥30% Improvement) at Day 42
Proportion of participants achieving ≥30% decrease from baseline in the pre-specified Children's Eating Behaviour Questionnaire (CEBQ) adverse-behavior composite (per SAP).
Time frame
Day 42Secondary outcomes
1
Change in Hoang Thi Bach Yen Anorexia Scale (Vietnamese Caregiver-Reported Pediatric Anorexia Scale) Total Score from Baseline to Day 42
The Hoang Thi Bach Yen Anorexia Scale (2020) is a validated Vietnamese caregiver-reported instrument to assess poor appetite in children. It includes 8 items covering mealtime characteristics (duration, amount of food intake) and eating behaviors (oppositional behavior, avoidance, food selectivity, food refusal). Each item is scored from 0 to 3 (0 = no symptom, 3 = severe symptom). The total score ranges from 0 to 24. Higher scores indicate worse appetite (more severe anorexia). Lower scores indicate better appetite. A negative change (Day 42 - Baseline \< 0) reflects clinical improvement.
Time frame
Baseline to Day 422
Change in Body Weight from Baseline to Day 42
Body weight will be measured in kilograms (kg) at baseline and Day 42. The outcome is the mean change (Day 42 - Baseline). Weight-for-age Z-scores based on WHO growth standards may also be summarized descriptively.
Time frame
Baseline to Day 423
Change in Number of Daily Meals from Baseline to Day 42
Caregiver-reported average number of meals per day over the prior week; outcome is change (Day 42 - Baseline).
Time frame
Baseline to Day 424
Change in Mean Meal Duration from Baseline to Day 42
Caregiver-reported average minutes per meal over the prior week; outcome is change (Day 42 - Baseline).
Time frame
Baseline to Day 42Sponsors and contacts
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Source ClinicalTrials.gov