Infant Restore: Efficacy of Microbiome Analysis and Education

Infant Restore: Investigating the Efficacy of a Microbiome Analysis, Education, and Recommendation Program in Improving Infant Gut Health

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Eczema; Microbiota; Microbiome; Gut Microbiome
• Intervention / Treatment: Dietary supplement: Tailored Recommendations; Behavioral: Consult Call; Behavioral: Email Series

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fredericksburg, Texas, United States, 78749
      • Seeding Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants in the intervention arm will receive comprehensive support to improve their infant's gut health over six months.	Dietary supplement: Tailored Recommendations; Based on the microbiome analysis, participants will receive personalized action plans. These plans include dietary, lifestyle, and supplemental suggestions to improve their infant's gut health.; Behavioral: Consult Call; Participants will have seven consult calls with a Gut Health Coach over the course of the study. These calls will provide guidance on the gut health reports, action plans, and any questions or concerns parents may have.; Behavioral: Email Series; Parents will receive a series of educational emails covering topics such as the importance of gut health, breastfeeding benefits, the impact of C-section delivery on the microbiome, and tips for introducing solid foods.
No Intervention: Control; Participants in the control arm will serve as a comparison group and will not receive the intervention during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota composition	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.	6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Educational	Asses parental understanding and engagement in gut health.	6 months
Gut reacted symptoms	Measure changes in newborn symptoms known to be influenced by gut microbiome e.g. colic, GI upset, sleep issues, eczema.	6 months

Collaborators and Investigators

• Sponsor: Seeding, Inc DBA Tiny Health
• Investigators: Principal Investigator: Kimberley Sukhum, PhD, Seeding Inc

Publications and helpful links

General Publications

• Shao Y, Forster SC, Tsaliki E, Vervier K, Strang A, Simpson N, Kumar N, Stares MD, Rodger A, Brocklehurst P, Field N, Lawley TD. Stunted microbiota and opportunistic pathogen colonization in caesarean-section birth. Nature. 2019 Oct;574(7776):117-121. doi: 10.1038/s41586-019-1560-1. Epub 2019 Sep 18.
• Galazzo G, van Best N, Bervoets L, Dapaah IO, Savelkoul PH, Hornef MW; GI-MDH consortium; Lau S, Hamelmann E, Penders J. Development of the Microbiota and Associations With Birth Mode, Diet, and Atopic Disorders in a Longitudinal Analysis of Stool Samples, Collected From Infancy Through Early Childhood. Gastroenterology. 2020 May;158(6):1584-1596. doi: 10.1053/j.gastro.2020.01.024. Epub 2020 Jan 18.
• O'Neill I, Schofield Z, Hall LJ. Exploring the role of the microbiota member Bifidobacterium in modulating immune-linked diseases. Emerg Top Life Sci. 2017 Nov 30;1(4):333-349. doi: 10.1042/ETLS20170058.
• Roswall J, Olsson LM, Kovatcheva-Datchary P, Nilsson S, Tremaroli V, Simon MC, Kiilerich P, Akrami R, Kramer M, Uhlen M, Gummesson A, Kristiansen K, Dahlgren J, Backhed F. Developmental trajectory of the healthy human gut microbiota during the first 5 years of life. Cell Host Microbe. 2021 May 12;29(5):765-776.e3. doi: 10.1016/j.chom.2021.02.021. Epub 2021 Mar 31.
• Vandenplas Y, De Greef E, Veereman G. Prebiotics in infant formula. Gut Microbes. 2014;5(6):681-7. doi: 10.4161/19490976.2014.972237.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Estimated): April 14, 2025
• Study Completion (Estimated): April 14, 2025

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: IR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No