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

NCT07153549 | Recruiting

• 2 other identifiers: CTBE.25.02Protocol No.: CTBE.25.02
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Feeding and Eating Disorders of Childhood; Appetite Disorders; Functional Poor Appetite

Keywords

functional poor appetite; pediatric feeding problems; feeding difficulty; loss of appetite; eating/feeding behavior; Children's Eating Behaviour Questionnaire; toddler; infants; zinc supplement; dietary supplement; Biolizin

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline to Day 42

• 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.

  Baseline to Day 42

• 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.

  Baseline to Day 42

• 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).

  Day 42

Secondary Outcomes (8)

• Change in Hoang Thi Bach Yen Anorexia Scale (Vietnamese Caregiver-Reported Pediatric Anorexia Scale) Total Score from Baseline to Day 42

  Baseline to Day 42

• Change in Body Weight from Baseline to Day 42

  Baseline to Day 42

• Change in Number of Daily Meals from Baseline to Day 42

  Baseline to Day 42

• Change in Mean Meal Duration from Baseline to Day 42

  Baseline to Day 42

• Change in Caregiver-Rated Cooperation During Meals Scale Score from Baseline to Day 42

  Baseline to Day 42

Study Arms (2)

Biolizin Syrup + Standardized Caregiver Counseling

EXPERIMENTAL

Children receive an oral zinc-containing dietary supplement (Biolizin syrup) for 42 days, dosed by age per protocol, together with standardized caregiver counseling on responsive feeding at each study visit (Day 0, Day 7, Day 21, Day 42). Adherence is monitored with dosing diaries and returned bottle counts. Use of other zinc-containing products or appetite stimulants is not permitted. Outcomes (feeding-difficulty score, CEBQ subscales, anthropometrics, and safety labs) are collected per schedule

Dietary Supplement: Biolizin; Behavioral: Standardized caregiver counseling on responsive feeding

Counseling Only (Standardized Feeding-Behavior Counseling)

ACTIVE COMPARATOR

Children receive the same standardized caregiver counseling on responsive feeding at each study visit (Day 0, Day 7, Day 21, Day 42) without Biolizin or any other zinc-containing supplement. Education materials, visit frequency, and assessments match the experimental arm. Concomitant appetite stimulants or zinc products are not allowed. Outcomes are collected per the same schedule.

Behavioral: Standardized caregiver counseling on responsive feeding

Interventions

Biolizin DIETARY_SUPPLEMENT

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.

Biolizin Syrup + Standardized Caregiver Counseling

Standardized caregiver counseling on responsive feeding BEHAVIORAL

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.

Biolizin Syrup + Standardized Caregiver Counseling; Counseling Only (Standardized Feeding-Behavior Counseling)

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haiphong University of Medicine and Pharmacy: lead

Study Sites (1)

Clinical Trial and Bioequivalence Center

Haiphong, Hai Phong, 180000, Vietnam

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders of Childhood; Feeding and Eating Disorders; Anorexia; Feeding Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Central Study Contacts

Phuong Thi Thu Nguyen, MD, PhD

CONTACT

+84936685007; nttphuong@hpmu.edu.vn

Anh Van Tran, MSc

CONTACT

0343035492; tvanh@hpmu.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable (open-label)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups: zinc-containing oral supplement (Biolizin) plus standardized caregiver counseling versus counseling only; follow-up for 42 days; age-stratified randomization (6-12 vs 13-36 months)

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 4, 2025
• Study Start: September 20, 2025
• Primary Completion: April 25, 2026
• Study Completion: April 30, 2026
• Last Updated: January 30, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting documents will be available beginning \~6-12 months after publication of the primary results and for 36 months thereafter. If no publication occurs, availability will begin within 24 months after last patient last visit and continue for 36 months.
• Access Criteria: Qualified researchers from academic, non-profit, or health-care institutions may request access by submitting a methodologically sound proposal and analysis plan to the Sponsor/PI (see Contacts). Requests require IRB/ethics determination or waiver and a signed Data Use Agreement. Upon approval, de-identified data and documents will be provided via secure, access-controlled repository or encrypted file transfer. Re-identification attempts and onward sharing are prohibited; use is limited to the approved objectives.

Locations

VN (1)