Flourish Study: A Randomized, Three-Arm Longitudinal Clinical Study of Microbiome-Guided Interventions in Cesarean-Born Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Microbiota Composition
研究概览
简要总结
The goal of this clinical trial is to learn whether microbiome analysis, education, and personalized recommendations can improve gut health and reduce early markers of immune-related conditions in infants aged 0-3 months delivered via Cesarean section. The study aims to determine whether these interventions can increase beneficial bacteria, decrease C-section-associated microbiome signatures, reduce opportunistic pathogens, and improve functional potential for HMO digestion and SCFA production. The study also seeks to assess whether improvements in microbiome composition are associated with a reduced prevalence of early atopic symptoms.
Researchers will compare three groups: a full intervention arm that receives microbiome reports, coaching, personalized recommendations, and educational materials; a limited intervention arm that receives simplified reports and basic recommendations; and a control arm that receives no results until study completion. This design allows evaluation of both a comprehensive intervention and a more scalable, minimal-results model.
Participants will:
- Provide six microbiome stool samples over a 24-month period.
- Provide additional small stool samples at two timepoints for exploratory metabolomic analysis.
- Receive microbiome reports and guidance according to their assigned study arm.
- Complete surveys on infant health history, symptoms, diet, and environmental exposures.
- Participate in standardized eczema assessment(s) administered by a Nurse Practitioner and evaluated by a Pediatric Allergy Specialist if any symptoms are reported.
This study seeks to demonstrate that targeted microbiome support can positively shift gut microbial development in C-section infants and may reduce risks linked to the early stages of the atopic march. Findings may inform scalable strategies for delivering microbiome-based support in early life and improve long-term health outcomes for this high-risk population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants are qualified for this study if they are 0 to 3 months of age at time of enrollment.
- •Infants must have been delivered via Cesarean delivery (C-section), either scheduled or emergent.
- •Infants must have been at least 36 weeks gestation at time of delivery.
- •Infants and their caregivers must reside in the United States with a US mailing address.
排除标准
- •Infants can not have been given probiotic supplements in their life at recruitment. This includes probiotic powder or supplements or formula with probiotic addition or multivitamin with probiotic addition.
- •Twin and multiple birth infants are not accepted in this study.
- •Infants cannot have the following existing health conditions:
- •Gastrointestinal conditions: Hirschsprung disease, eosinophilic gastrointestinal disorders (EGID) including eosinophilic esophagitis (EoE), necrotizing enterocolitis (NEC), short bowel syndrome (SBS)
- •Immune or auto-immune conditions: Severe Combined Immunodeficiency (SCID), human immunodeficiency virus (HIV)), excluding eczema and rashes
- •Congenital conditions: cleft lip or cleft palate, congenital heart disease, cerebral palsy, fragile X syndrome, down syndrome, spina bifida, cystic fibrosis, phenylketonuria (PKU), congenital hypothyroidism (CHT), galactosaemia)
- •Blood disorders (sickle cell disease, thalassemia, hemophilia)
- •Infant or any immediate family member has previously received results from an at-home microbiome stool test (excluding standard clinical diagnostic testing such as stool culture or pathogen testing)
研究组 & 干预措施
Full Intervention
Participants in the full intervention arm will receive interactive microbiome reports, coaching, personalized recommendations, and educational materials throughout the length of the study.
干预措施: Tailored Recommendations (Dietary Supplement)
Full Intervention
Participants in the full intervention arm will receive interactive microbiome reports, coaching, personalized recommendations, and educational materials throughout the length of the study.
干预措施: Consult Call (Behavioral)
Full Intervention
Participants in the full intervention arm will receive interactive microbiome reports, coaching, personalized recommendations, and educational materials throughout the length of the study.
干预措施: Educational Email Series (Behavioral)
Limited Intervention Arm
Participants in the limited intervention arm will receive simplified pdf reports with basic probiotic recommendations throughout the study. This arm has the option to participate in report interpretation calls with a Nurse Practitioner.
干预措施: Tailored Recommendations (Dietary Supplement)
Limited Intervention Arm
Participants in the limited intervention arm will receive simplified pdf reports with basic probiotic recommendations throughout the study. This arm has the option to participate in report interpretation calls with a Nurse Practitioner.
干预措施: Consult Call (Behavioral)
Control Arm
Participants in the control arm will provide the same level of microbiome and survey data as the intervention arms but will not see their results until after the completion of the study.
结局指标
主要结局
Microbiota Composition
时间窗: 24 months
Changes in gut microbiota composition, including relative abundance of beneficial bacterial taxa such as Bifidobacterium, assessed using shotgun metagenomic sequencing.
C-Section-Associated Microbiome Signatures
时间窗: 24 months
Changes in the relative abundance of microbial taxa and signatures previously associated with Cesarean delivery, assessed longitudinally using shotgun metagenomic sequencing.
Opportunistic and Potentially Pathogenic Microbial Abundance
时间窗: 24 months
Changes in the relative abundance of opportunistic and potentially pathogenic microbial taxa over time, assessed using shotgun metagenomic sequencing.
Functional Microbiome Capacity
时间窗: 24 months
Changes in microbial functional gene pathways related to human milk oligosaccharide (HMO) digestion and short-chain fatty acid (SCFA) production, assessed using metagenomic functional profiling.
Eczema Incidence / Atopic Symptoms
时间窗: 24 months
Incidence of eczema and other early atopic symptoms assessed via parent-reported surveys and standardized eczema assessment when symptoms are reported.
次要结局
- HMO Digestion Functional Capacity(24 months)
- Parent-Reported Infant Health Outcomes(24 months)
- SCFA Production Functional Capacity(24 months)