Trials
Search / Trial NCT06424691

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.

Locations

Fredericksburg, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0