Evaluation of the Efficacy and Safety of the Multistrain Probiotic "BioAmicus Complete" in Improving Gastrointestinal Symptoms in Children Aged 0-24 Months: A Randomized, Open-Label, Parallel-Group, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change from Baseline in Infant Gastrointestinal Symptom Questionnaire (IGSQ) Total Score at Day 42
研究概览
简要总结
Infants often experience functional gastrointestinal symptoms (e.g., colic, excessive gas, regurgitation, constipation, or loose stools) that distress families and may reflect an imbalance of the gut microbiome. This study evaluates whether the multistrain probiotic BioAmicus Complete can improve caregiver-reported gastrointestinal symptoms in infants 0-24 months and is safe for use in this population.
The primary assessment is the change in the Infant Gastrointestinal Symptom Questionnaire (IGSQ) total score from the start to the end of the study period. Secondary assessments include symptom domains (colic/regurgitation, stool frequency and consistency), caregiver quality of life, growth parameters (weight and length), health care utilization and antibiotic exposure, and overall safety/tolerability (adverse events and serious adverse events). Stool samples will be analyzed to explore changes in the gut microbiome.
详细描述
caregiver burden and health care visits. Modulating the developing gut microbiome with probiotics may alleviate these symptoms. BioAmicus Complete is a multistrain probiotic designed to support a healthy intestinal microbiota; systematic clinical evaluation is warranted to determine its efficacy and safety in infants.
Objectives:
Primary: Determine whether BioAmicus Complete improves overall gastrointestinal symptoms versus usual care, measured by change in IGSQ total score between baseline and study end.
Exploratory (microbiome): Characterize changes in stool microbiome composition and diversity across the study period.
Secondary: Compare groups on symptom domain scores (e.g., colic, regurgitation, stooling patterns), caregiver burden/quality of life, health care utilization and antibiotic exposure, growth parameters, and safety outcomes (adverse events, serious adverse events, and product-related events).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-24 months at enrollment.
- •Infant has clinician-assessed functional gastrointestinal symptoms (e.g., colic/irritability, regurgitation, constipation, loose stools), judged suitable for study participation.
- •Parent or legal guardian provides written informed consent and agrees to comply with study procedures (questionnaires/diaries and sample collection, if applicable).
- •Caregivers agree to avoid other probiotic products during the study period, except as directed by the study team.
排除标准
- •Major congenital gastrointestinal anomalies or known chronic gastrointestinal diseases requiring ongoing prescription therapy (e.g., Hirschsprung disease, inflammatory bowel disease, short-bowel syndrome).
- •Clinically unstable condition or severe/critical illness that could interfere with participation or safety in the opinion of the investigator.
- •Known or suspected primary or secondary immunodeficiency, or current immunosuppressive therapy.
- •History of severe allergy or hypersensitivity to components of the investigational product.
- •Recent use of systemic antibiotics within 14 days prior to baseline, or use of probiotic supplements within 14 days prior to baseline (per protocol).
- •Participation in another interventional clinical trial within 30 days prior to enrollment or during the study.
- •Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or confound outcome assessments.
研究组 & 干预措施
BioAmicus Complete + Usual Care
Participants receive BioAmicus Complete (multistrain probiotic) oral drops in addition to usual care for infant functional GI symptoms. Product is administered by caregivers per protocol/label for 42 days; adherence is recorded. No other probiotic products are permitted during the study. Concomitant medications and routine management are allowed at the investigator's discretion.
干预措施: BioAmicus Complete (Dietary Supplement)
BioAmicus Complete + Usual Care
Participants receive BioAmicus Complete (multistrain probiotic) oral drops in addition to usual care for infant functional GI symptoms. Product is administered by caregivers per protocol/label for 42 days; adherence is recorded. No other probiotic products are permitted during the study. Concomitant medications and routine management are allowed at the investigator's discretion.
干预措施: Usual Care (No Probiotic) (Other)
Usual Care Alone
Participants receive standard clinical management per local practice for infant functional gastrointestinal symptoms. No probiotic supplementation is provided (participants are asked to avoid other probiotic products during the study). Concomitant medications and supportive care may be used as clinically indicated at the investigator's discretion.
干预措施: Usual Care (No Probiotic) (Other)
结局指标
主要结局
Change from Baseline in Infant Gastrointestinal Symptom Questionnaire (IGSQ) Total Score at Day 42
时间窗: Baseline to Day 42
IGSQ is a 13-item, caregiver-reported questionnaire (total score 13-65; higher scores indicate worse symptoms). Change is calculated as Day 42 minus baseline; a negative change indicates improvement
Stool Microbiome - Change in Alpha Diversity (Shannon, Chao1)
时间窗: Baseline to Day 42
16S rRNA gene sequencing of stool at baseline and Day 42; alpha diversity indices computed and change analyzed within and between groups.
次要结局
- Change in Stool Frequency Based on Infant & Toddler GI Symptom Questionnaire from Baseline to Day 42(Baseline to Day 42)
- Change in Stool Consistency Using the Brussels Infant and Toddler Stool Scale (BITSS) from Baseline to Day 42(Up to Day 42)
- Stool Microbiome - Between-Group Difference in Beta Diversity (PERMANOVA)(Day 42)
- Change in Frequency of Regurgitation and Vomiting Episodes from Baseline to Day 42(Baseline to Day 42)
- Change in Colic Symptoms Based on Infant & Toddler GI Symptom Questionnaire from Baseline to Day 42(Baseline to Day 42)