Infant Restore: Efficacy of Microbiome Analysis and Education
Launched by SEEDING, INC DBA TINY HEALTH · May 21, 2024
Trial Information
Current as of February 12, 2025
Active, not recruiting
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Infants are qualified for this study if they are 0 to 3 months of age at time of enrollment.
- • Infant was delivered via Cesarean delivery (C-section).
- Exclusion Criteria:
- • Infants cannot 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 must be full term or no less than 36-weeks gestation at delivery.
- • Infants must be residents of the United States with US postal service.
- * Infants cannot have the following existing health conditions:
- • Pre-existing gut conditions (Hirschsprung disease, eosinophilic gastrointestinal disorders (EGID) such as 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)
- • Infants are excluded if they or any of their immediate family members have received results from an at-home microbiome stool test in the past. This does not include clinical workup such as culture or pathogen testing.
Trial Officials
Kimberley Sukhum, PhD
Principal Investigator
Seeding INC
About Seeding, Inc Dba Tiny Health
Seeding, Inc., operating under the brand name Tiny Health, is an innovative clinical trial sponsor dedicated to advancing research in the field of microbiome health and its impact on human wellness. With a focus on harnessing cutting-edge technology and data analytics, Tiny Health aims to develop individualized health solutions through rigorous scientific inquiry and collaboration. The organization is committed to improving patient outcomes by facilitating robust clinical trials that explore the intricate relationships between gut health, immune function, and overall health, paving the way for personalized therapeutic interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fredericksburg, Texas, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0