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Flourish: Exploring the Early Infant Gut Microbiome

S

Seeding, Inc DBA Tiny Health

Status

Not yet enrolling

Conditions

Gut Microbiome
Microbiome
Eczema
Microbiota

Treatments

Behavioral: Educational Email Series
Behavioral: Consult Call
Dietary Supplement: Tailored Recommendations

Study type

Interventional

Funder types

Industry

Identifiers

NCT07333482
FLOURISH_14952

Details and patient eligibility

About

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:

  1. Provide six microbiome stool samples over a 24-month period.
  2. Provide additional small stool samples at two timepoints for exploratory metabolomic analysis.
  3. Receive microbiome reports and guidance according to their assigned study arm.
  4. Complete surveys on infant health history, symptoms, diet, and environmental exposures.
  5. 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.

Enrollment

250 estimated patients

Sex

All

Ages

Under 3 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 3 patient groups

Full Intervention
Experimental group
Description:
Participants in the full intervention arm will receive interactive microbiome reports, coaching, personalized recommendations, and educational materials throughout the length of the study.
Treatment:
Dietary Supplement: Tailored Recommendations
Behavioral: Educational Email Series
Behavioral: Consult Call
Limited Intervention Arm
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Tailored Recommendations
Behavioral: Consult Call
Control Arm
No Intervention group
Description:
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.

Trial contacts and locations

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Central trial contact

Kimberley Sukham, PhD; Claudia Nakama, MPH

Data sourced from clinicaltrials.gov

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