Feeding and Eating Disorders of ChildhoodCTBE2502NCT07153549
Biolizin for Improving Functional Poor Appetite in Children Aged 6 to 36 Months (CTBE2502)
A study testing Biolizin and Standardized caregiver counseling on responsive feeding in people with Feeding and Eating Disorders of Childhood and Appetite Disorders, run by Haiphong University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Feeding and Eating Disorders of Childhood, Appetite Disorders, Functional Poor Appetite
- What is being tested?
- Biolizin and Standardized caregiver counseling on responsive feeding
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, 180000
Van Anh Tran, MSc.Pharm, 0343035492, tvanh@hpmu.edu.vn
Phuong Thi Thu Nguyen, MD, PhD, nttphuong@hpmu.edu.vn
About this study
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
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
Read the detailed description
Poor appetite in toddlers often reflects a combination of nutritional and behavioral factors. Zinc is an essential trace element that contributes to taste perception, mucosal integrity, and appetite regulation; suboptimal zinc status may exacerbate reduced intake and feeding problems. Biolizin is an oral zinc-containing supplement intended to support appetite and healthy feeding behavior in young children. The study aims to determine whether the supplement, provided together with standardized caregiver counseling on responsive feeding practices, improves caregiver-reported feeding difficulty and eating behavior over 42 days. After consent and screening, eligible children attend visits at Day 0, Day 7 (±2), Day 21 (±3), and Day 42 (±4). At each visit, clinicians review medical history and concomitant treatments, record anthropometrics, and caregivers complete a validated Vietnamese feeding-difficulty scale (0-24, higher scores indicate worse difficulty) and the CEBQ subscales. The study product is taken orally per age-based dosing specified in the protocol; adherence is checked using dosing diaries and returned bottle counts where applicable. Safety laboratories (e.g., complete blood count, liver and renal chemistry) are planned at baseline and Day 42; serum zinc may be obtained according to protocol. Adverse events are collected from consent through Day 42 and are managed according to clinical judgment; expected reactions are generally mild (for example, gastrointestinal discomfort, taste changes, or rash). Source data are recorded in case report forms and entered into a secure database with audit trails, and only de-identified data are used for analysis or sharing. The study has ethics approval and written informed consent is obtained from caregivers before any procedures.
- Being tested
- Biolizin, Standardized caregiver counseling on responsive feeding
- 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
- Medical subject headings
- Feeding and Eating Disorders of Childhood, Feeding and Eating Disorders, Anorexia, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiolizinDietary 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.
Standardized caregiver counseling on responsive feedingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Standardized caregiver counseling on responsive feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
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.
Measured: Baseline to Day 42
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.
Measured: Baseline to Day 42
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).
Measured: Baseline to Day 42
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).
Measured: Baseline to Day 42
Change in Caregiver-Rated Cooperation During Meals Scale Score from Baseline to Day 42
Caregiver-Rated Cooperation During Meals Scale is a study-specific, caregiver-reported measure of mealtime cooperation. The instrument uses a 5-point Likert scale ranging from 1 (very uncooperative) to 5 (very cooperative). Higher scores indicate better cooperation (favorable outcome). A positive change (Day 42 - Baseline > 0) reflects improvement.
Measured: Baseline to Day 42
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Number and proportion of participants with ≥1 TEAE; events characterized by system organ class/preferred term and graded by CTCAE v5.0. Collected using the study's standard ADR form.
Measured: From first dose to Day 42
Change in Serum Zinc Concentration from Baseline to Day 42
Serum zinc (µg/dL) measured per site laboratory procedures; outcome is change (Day 42 - Baseline).
Measured: Baseline to Day 42
Change in Body Length/Height from Baseline to Day 42
Body length (for children <24 months) or standing height (for children ≥24 months) will be measured in centimeters (cm) at baseline and Day 42. The outcome is the mean change (Day 42 - Baseline). Length/height-for-age Z-scores based on WHO growth standards may also be summarized descriptively.
Measured: Baseline to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start20 Sep 2025
- Primary completion25 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating Disorders of ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haiphong University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153549
- Sponsor's protocol ID
- CTBE.25.02
- Other IDs
- Protocol No.: CTBE.25.02
- Acronym
- CTBE2502
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the primary and secondary outcomes will be shared, including: baseline demographics/clinical characteristics; CEBQ item- and subscale-level scores and the prespecified composite; Hoang Thi Bach Yen anorexia scale scores; anthropometrics and WHO Z-scores; serum zinc and laboratory safety values; adverse events; concomitant medications; intervention assignment and adherence. A data dictionary/codebook will accompany the dataset. Direct identifiers will be removed and indirect identifiers minimized per protocol and institutional policy.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07153549
- Acronym / sponsor ID
- CTBE2502 / CTBE.25.02
- Keywords
- functional poor appetite, pediatric feeding problems, feeding difficulty, loss of appetite, eating/feeding behavior, Children's Eating Behaviour Questionnaire, toddler, infants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Haiphong University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Poor appetite in toddlers often reflects a combination of nutritional and behavioral factors. Zinc is an essential trace element that contributes to taste perception, mucosal integrity, and appetite regulation; suboptimal zinc status may exacerbate reduced intake and feeding problems. Biolizin is an oral zinc-containing supplement intended to support appetite and healthy feeding behavior in young children. The study aims to determine whether the supplement, provided together with standardized caregiver counseling on responsive feeding practices, improves caregiver-reported feeding difficulty and eating behavior over 42 days. After consent and screening, eligible children attend visits at Day 0, Day 7 (±2), Day 21 (±3), and Day 42 (±4). At each visit, clinicians review medical history and concomitant treatments, record anthropometrics, and caregivers complete a validated Vietnamese feeding-difficulty scale (0-24, higher scores indicate worse difficulty) and the CEBQ subscales. The study product is taken orally per age-based dosing specified in the protocol; adherence is checked using dosing diaries and returned bottle counts where applicable. Safety laboratories (e.g., complete blood count, liver and renal chemistry) are planned at baseline and Day 42; serum zinc may be obtained according to protocol. Adverse events are collected from consent through Day 42 and are managed according to clinical judgment; expected reactions are generally mild (for example, gastrointestinal discomfort, taste changes, or rash). Source data are recorded in case report forms and entered into a secure database with audit trails, and only de-identified data are used for analysis or sharing. The study has ethics approval and written informed consent is obtained from caregivers before any procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Biolizin Syrup + Standardized Caregiver Counseling | Experimental | Dietary Supplement: Biolizin, Behavioral: Standardized caregiver counseling on responsive feedingChildren 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 |
| Counseling Only (Standardized Feeding-Behavior Counseling) | Active comparator | Behavioral: Standardized caregiver counseling on responsive feedingChildren 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. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age 6 to 36 months at screening.
- Functional poor appetite for ≥2 weeks with at least one of the following:
- 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.
Key exclusion criteria (12 listed)
- Ongoing acute or chronic illnesses that can affect intake or absorption, including but not limited to:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiolizinOral 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. | Dietary supplement | Biolizin Syrup + Standardized Caregiver Counseling |
| Standardized caregiver counseling on responsive feedingStructured 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. | Behavioural | Biolizin Syrup + Standardized Caregiver Counseling, Counseling Only (Standardized Feeding-Behavior Counseling) |
Primary outcome
Change in Children's Eating Behaviour Questionnaire (CEBQ) Composite Total Score from Baseline to Day 42
Time frame: 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.
Change in Children's Eating Behaviour Questionnaire (CEBQ) Food Approach Behaviors from Baseline to Day 42
Time frame: 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.
Change in Children's Eating Behaviour Questionnaire (CEBQ) Food Avoidant Behaviors from Baseline to Day 42
Time frame: 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.
Responder Rate on Children's Eating Behaviour Questionnaire (CEBQ) (≥30% Improvement) at Day 42
Time frame: 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).
8 secondary outcomes
Change in Hoang Thi Bach Yen Anorexia Scale (Vietnamese Caregiver-Reported Pediatric Anorexia Scale) Total Score from Baseline to Day 42
Time frame: Baseline to Day 42
Change in Body Weight from Baseline to Day 42
Time frame: Baseline to Day 42
Change in Number of Daily Meals from Baseline to Day 42
Time frame: Baseline to Day 42
Change in Mean Meal Duration from Baseline to Day 42
Time frame: Baseline to Day 42
Change in Caregiver-Rated Cooperation During Meals Scale Score from Baseline to Day 42
Time frame: Baseline to Day 42
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose to Day 42
Change in Serum Zinc Concentration from Baseline to Day 42
Time frame: Baseline to Day 42
Change in Body Length/Height from Baseline to Day 42
Time frame: Baseline to Day 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the primary and secondary outcomes will be shared, including: baseline demographics/clinical characteristics; CEBQ item- and subscale-level scores and the prespecified composite; Hoang Thi Bach Yen anorexia scale scores; anthropometrics and WHO Z-scores; serum zinc and laboratory safety values; adverse events; concomitant medications; intervention assignment and adherence. A data dictionary/codebook will accompany the dataset. Direct identifiers will be removed and indirect identifiers minimized per protocol and institutional policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biolizin and Standardized caregiver counseling on responsive feeding in people with Feeding and Eating Disorders of Childhood and Appetite Disorders, run by Haiphong University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phuong Thi Thu Nguyen, MD, PhD (+84936685007, nttphuong@hpmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Children's Eating Behaviour Questionnaire (CEBQ) Composite Total Score from Baseline to Day 42 (time frame: Baseline to Day 42). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.