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New treatment option for Feeding and Eating Disorders of Childhood
Official title Biolizin for Improving Functional Poor Appetite in Children Aged 6 to 36 Months (CTBE2502)
ClinicalTrials.gov ID: NCT07153549
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 36
You may be able to join 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;
You likely can't join 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...
- 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...
- Use of zinc-containing products or other appetite stimulants within 7 days before screening.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Haiphong, Hai Phong, Vietnam
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 36 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haiphong, Hai Phong, Vietnam. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.