## Protocol Section
### Identification Module
**NCT ID:** NCT06424691

**Brief Title:** Infant Restore: Efficacy of Microbiome Analysis and Education

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

#### Organization Study ID Info
**ID:** IR-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Seeding, Inc DBA Tiny Health
### Status Module
#### Completion Date
**Date:** 2025-04-14

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2025-04-14

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-05-04

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Seeding, Inc DBA Tiny Health

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Microbiota

- Eczema

- Microbiome

- Gut Microbiome

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants in the intervention arm will receive comprehensive support to improve their infant's gut health over six months.

**Intervention Names:**

- Dietary Supplement: Tailored Recommendations

- Behavioral: Consult Call

- Behavioral: Email Series

**Label:** Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants in the control arm will serve as a comparison group and will not receive the intervention during the study period.

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

**Description:** 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.

**Name:** Tailored Recommendations

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Intervention

**Description:** 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.

**Name:** Consult Call

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Intervention

**Description:** 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.

**Name:** Email Series

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** Asses parental understanding and engagement in gut health.

**Measure:** Educational

**Time Frame:** 6 months

**Description:** Measure changes in newborn symptoms known to be influenced by gut microbiome e.g. colic, GI upset, sleep issues, eczema.

**Measure:** Gut reacted symptoms

**Time Frame:** 6 months

#### Primary Outcomes

**Description:** 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.

**Measure:** Microbiota composition

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** Detect signature shifts from a C-section signature to a vaginally born signature

**Measure:** C-section signature

**Time Frame:** 6 months

**Description:** Compare atopic march signatures of intervention arm versus control subjects

**Measure:** Atopic march signature

**Time Frame:** 6 months

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 3 Months

**Minimum Age:** 0 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Fredericksburg

**Country:** United States

**Facility:** Seeding INC

**State:** Texas

**Zip:** 78749

#### Overall Officials

**Official 1:**

**Affiliation:** Seeding INC

**Name:** Kimberley Sukhum, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**PMID:** 31958431

**Citation:** 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.

**PMID:** 31534227

**Citation:** 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.

**PMID:** 33525778

**Citation:** 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.

**PMID:** 33794185

**Citation:** Vandenplas Y, De Greef E, Veereman G. Prebiotics in infant formula. Gut Microbes. 2014;5(6):681-7. doi: 10.4161/19490976.2014.972237.

**PMID:** 25535999

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003872

- Term: Dermatitis

- ID: D000012871

- Term: Skin Diseases

- ID: D000017443

- Term: Skin Diseases, Eczematous

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7655

- Name: Eczema

- Relevance: HIGH

- As Found: Eczema

- ID: M7067

- Name: Dermatitis

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19712

- Name: Skin Diseases, Eczematous

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004485

- Term: Eczema

### Misc Info Module

- Version Holder: 2024-05-31
