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New treatment option for Microbiota
Official title Flourish: Exploring the Early Infant Gut Microbiome
ClinicalTrials.gov ID: NCT07333482
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 3. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- Infants can not have been given probiotic supplements in their life at recruitment. This includes probiotic powder or supplements or formula with...
- 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)...
- 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...
See the full eligibility 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.
- 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)...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Austin, Texas, United States
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, 0 months to 3 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austin, Texas, United States. 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.