Clinical trial 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 study wants to see if checking gut bacteria and giving personalized advice can improve gut health and lower early signs of immune issues like eczema.
- Who it's for
- Babies aged 0 to 3 months who were born by Cesarean section (C-section).
- What's involved
- Parents will provide stool samples, receive gut health reports and coaching, and fill out surveys about the baby's health and diet.
- Time commitment
- The study lasts 24 months and requires providing six stool samples and completing health surveys.
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.
- Twin and multiple birth infants are not accepted in this study.
- 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...
- Blood disorders (sickle cell disease, thalassemia, hemophilia)
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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Austin, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.