Infant Restore: Efficacy of Microbiome Analysis and Education

Not Applicable

Active, not recruiting

• Conditions: Microbiota; Microbiome; Eczema; Gut Microbiome
• Interventions: Dietary Supplement: Tailored Recommendations; Behavioral: Consult Call; Behavioral: Email Series

• Registration Number: NCT06424691
• Lead Sponsor: Seeding, Inc DBA Tiny Health

Brief Summary

The goal of this clinical trial is to learn if a microbiome analysis, education, and recommendation program can improve gut health, reduce future health risks, and empower parents in their children's health in infants aged 0-3 months delivered via Cesarean section. The main questions it aims to answer are: Will the intervention increase bacteria considered beneficial, decrease the C- section microbiome signatures, promote a reduction in opportunistic pathogens, and improved functional potential for HMO digestion and SCFA production Will the intervention decrease microbiome signatures associated with atopic march conditions.

Researchers will compare participants in the intervention arm, who will receive microbiome reports, personalized action plans, and educational materials, to participants in the control arm, who will receive microbiome results and educational materials after the study's completion, to see if the intervention leads to improved gut health and reduced risk of health conditions.

Participants will:

* Provide two microbiome stool samples three months apart.

* Receive detailed infant gut health reports via the Tiny Health app.

* Receive personalized action plans tailored to their infant's gut health needs.

* Engage in gut health coaching sessions with a microbiome expert.

* Receive an educational email series on infant gut health.

* Complete a series of surveys/questionnaires on health history, symptoms, and diet.

This study seeks to demonstrate that targeted microbiome interventions can significantly improve early infant gut health, leading to potential long-term health benefits. These benefits may include reduced healthcare costs by lowering the incidence of related chronic conditions. By establishing a foundation for mitigating these conditions, the intervention could consequently result in fewer doctor visits, reduced need for medications, and a lower incidence of hospitalizations over the first 3-4 years of the infant's life.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-04
• Status Verified: 2024-05
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Primary Completion: 2025-04-14
• Study Completion: 2025-04-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Consult Call	Participants in the intervention arm will receive comprehensive support to improve their infant's gut health over six months.
Intervention	Email Series	Participants in the intervention arm will receive comprehensive support to improve their infant's gut health over six months.
Intervention	Tailored Recommendations	Participants in the intervention arm will receive comprehensive support to improve their infant's gut health over six months.

Primary Outcome Measures

Name	Time	Method
Microbiota composition	6 months	Assess changes in beneficial bacteria (Bifidobacterium) and C-section microbiome signatures. Detect levels of opportunistic pathogens, and changes in functional potential for HMO digestion and SCFA production.

Secondary Outcome Measures

Name	Time	Method
C-section signature	6 months	Detect signature shifts from a C-section signature to a vaginally born signature
Atopic march signature	6 months	Compare atopic march signatures of intervention arm versus control subjects

Trial Locations

Locations (1)

Seeding INC; 🇺🇸 Fredericksburg, Texas, United States