MicrobiotaNCT06424691
Infant Restore: Efficacy of Microbiome Analysis and Education
A study testing Tailored Recommendations, Consult Call and Email Series in people with Microbiota and Eczema, run by Seeding Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Microbiota, Eczema, Microbiome
- What is being tested?
- Tailored Recommendations, Consult Call and Email Series
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2023to 14 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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))
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Microbiota, Eczema, Microbiome, Gut Microbiome
- Being tested
- Tailored Recommendations, Consult Call, Email Series
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored RecommendationsDietary supplement
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.
Consult CallBehavioural
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.
Email SeriesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention arm will receive comprehensive support to improve their infant's gut health over six months. Receives: Dietary Supplement: Tailored Recommendations; Behavioral: Consult Call; Behavioral: Email Series |
| Control | No intervention | Participants in the control arm will serve as a comparison group and will not receive the intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
C-section signature
Detect signature shifts from a C-section signature to a vaginally born signature
Measured: 6 months
Atopic march signature
Compare atopic march signatures of intervention arm versus control subjects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start4 May 2023
- Primary completion14 Apr 2025 (estimated)
- Study completion14 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seeding Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberley Sukhum, PhD, Principal investigator, Seeding Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424691
- Sponsor's protocol ID
- IR-001
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31958431Shao 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.
PubMed 31534227O'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.
PubMed 33525778Roswall 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.
PubMed 33794185Vandenplas Y, De Greef E, Veereman G. Prebiotics in infant formula. Gut Microbes. 2014;5(6):681-7. doi: 10.4161/19490976.2014.972237.
PubMed 25535999Nieto PA, Nakama C, Trachsel J, Goad D, Soderborg TK, Tan DS, Orlandi A, Yuan Q, Song E, Mueller NT, Mars RA, Hoy CS, Sukhum KV. Improving immune-related health outcomes post-cesarean birth with a gut microbiome-based program: A randomized controlled trial. Pediatr Allergy Immunol. 2025 Sep;36(9):e70182. doi: 10.1111/pai.70182.
PubMed 40898384
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Restore: Investigating the Efficacy of a Microbiome Analysis, Education, and Recommendation Program in Improving Infant Gut Health
- ClinicalTrials.gov ID
- NCT06424691
- Acronym / sponsor ID
- IR-001
- Conditions
- Microbiota, Eczema, Microbiome, Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seeding IncIndustry (pharma, biotech, devices)
- Study start
- 4 May 2023 (actual)
- Primary completion
- 14 Apr 2025 (estimated)
- Study completion
- 14 Apr 2025 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Tailored Recommendations, Behavioral: Consult Call, Behavioral: Email SeriesParticipants in the intervention arm will receive comprehensive support to improve their infant's gut health over six months. |
| Control | No intervention | –Participants in the control arm will serve as a comparison group and will not receive the intervention during the study period. |
Who may qualify
- Ages
- 0 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored RecommendationsBased 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. | Dietary supplement | Intervention |
| Consult CallParticipants 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. | Behavioural | Intervention |
| Email SeriesParents 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. | Behavioural | Intervention |
Primary outcome
Microbiota composition
Time frame: 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.
2 secondary outcomes
C-section signature
Time frame: 6 months
Atopic march signature
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 31958431Galazzo 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.
- Background: PubMed 31534227Shao 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.
- Background: PubMed 33525778O'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.
- Background: PubMed 33794185Roswall 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.
- Results publication: PubMed 25535999Vandenplas Y, De Greef E, Veereman G. Prebiotics in infant formula. Gut Microbes. 2014;5(6):681-7. doi: 10.4161/19490976.2014.972237.
- Derived from this study: PubMed 40898384Nieto PA, Nakama C, Trachsel J, Goad D, Soderborg TK, Tan DS, Orlandi A, Yuan Q, Song E, Mueller NT, Mars RA, Hoy CS, Sukhum KV. Improving immune-related health outcomes post-cesarean birth with a gut microbiome-based program: A randomized controlled trial. Pediatr Allergy Immunol. 2025 Sep;36(9):e70182. doi: 10.1111/pai.70182.
- Individual participant dataSharing planned: No
Related trials for Microbiota
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Active, not recruitingPhase 2
Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
Multi-Drug Resistant Organism Colonization
Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
RecruitingObservational study
Westlake Aging Cohort (WeAC)
Aging, Cognition Improvement
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberley Sukhum, PhD principal investigator
Seeding Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Recommendations, Consult Call and Email Series in people with Microbiota and Eczema, run by Seeding Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota composition (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06424691, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.