MicrobiotaNCT07333482
Flourish: Exploring the Early Infant Gut Microbiome
A study testing Tailored Recommendations, Consult Call and Educational Email Series in people with Microbiota and Gut Microbiome, run by Seeding Inc at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether microbiome analysis, education, and personalized recommendations can improve gut health and reduce early markers of immune-related conditions 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, Gut Microbiome, Eczema
- What is being tested?
- Tailored Recommendations, Consult Call and Educational Email Series
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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.
- Infants must have been delivered via Cesarean delivery (C-section), either scheduled or emergent.
- Infants must have been at least 36 weeks gestation at time of delivery.
- Infants and their caregivers must reside in the United States with a US mailing address.
Who cannot join
- Infants can not 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 cannot have the following existing health conditions:
- Gastrointestinal conditions: Hirschsprung disease, eosinophilic gastrointestinal disorders (EGID) including 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)
- Infant or any immediate family member has previously received results from an at-home microbiome stool test (excluding standard clinical diagnostic testing such as stool culture or pathogen testing)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Seeding Labs INC
Austin, Texas, 78749
Kim Sukhum, PhD, 502-437-9588, hello@seedinglabs.co
About this study
Official title: Flourish Study: A Randomized, Three-Arm Longitudinal Clinical Study of Microbiome-Guided Interventions in Cesarean-Born Infants
The goal of this clinical trial is to learn whether microbiome analysis, education, and personalized recommendations can improve gut health and reduce early markers of immune-related conditions in infants aged 0-3 months delivered via Cesarean section. The study aims to determine whether these interventions can increase beneficial bacteria, decrease C-section-associated microbiome signatures, reduce opportunistic pathogens, and improve functional potential for HMO digestion and SCFA production. The study also seeks to assess whether improvements in microbiome composition are associated with a reduced prevalence of early atopic symptoms.
Researchers will compare three groups: a full intervention arm that receives microbiome reports, coaching, personalized recommendations, and educational materials; a limited intervention arm that receives simplified reports and basic recommendations; and a control arm that receives no results until study completion. This design allows evaluation of both a comprehensive intervention and a more scalable, minimal-results model.
Read more
Participants will:
- Provide six microbiome stool samples over a 24-month period.
- Provide additional small stool samples at two timepoints for exploratory metabolomic analysis.
- Receive microbiome reports and guidance according to their assigned study arm.
- Complete surveys on infant health history, symptoms, diet, and environmental exposures.
- Participate in standardized eczema assessment(s) administered by a Nurse Practitioner and evaluated by a Pediatric Allergy Specialist if any symptoms are reported.
This study seeks to demonstrate that targeted microbiome support can positively shift gut microbial development in C-section infants and may reduce risks linked to the early stages of the atopic march. Findings may inform scalable strategies for delivering microbiome-based support in early life and improve long-term health outcomes for this high-risk population.
- Conditions
- Microbiota, Gut Microbiome, Eczema, Microbiome
- Being tested
- Tailored Recommendations, Consult Call, Educational 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
Recommendations are tailored to the infant's microbiome composition, functional gene profiles (e.g., HMO digestion and SCFA production pathways), age, feeding method, and reported symptoms.
Guidance may include evidence-based suggestions related to probiotic use, prebiotic intake, and age-appropriate nutritional strategies intended to support healthy gut microbiome development. All recommendations are educational in nature, optional, and provided for consideration by parents or caregivers. No supplements are provided directly as part of the study, and no supplementation is required for study participation.
Recommendations are updated over time as new microbiome data are collected and are delivered according to study arm assignment. The full intervention arm receives comprehensive, personalized recommendations with interpretive support, while the limited intervention arm receives probiotic recommendations only designed to model a scalable laboratory-developed test (LDT)-style approach.
Consult CallBehavioural
Participants assigned to the full intervention arm will receive scheduled consult calls with a trained microbiome specialist as part of the study intervention. These are conducted remotely and are designed to support participant understanding of microbiome reports, review educational content, and discuss microbiome-informed recommendations in the context of the infant's age, feeding practices, and reported symptoms.
For participants in the full intervention arm, consult calls may include discussion of microbiome-guided recommendations related to diet, supplementation, and lifestyle factors. Participants in the limited intervention arm may elect to receive a call with a licensed Nurse Practitioner for the purpose of interpreting their static microbiome report only; these calls do not include personalized recommendations or discussion of broader health symptoms. Participants in the control arm do not receive consult calls during the active study period.
Educational Email SeriesBehavioural
Participants assigned to the full intervention arm will receive a structured educational email series delivered longitudinally over the course of the study. The email series provides evidence-based education on early infant gut microbiome development and its relationship to immune and allergic health outcomes, with links to blog articles summarizing current peer-reviewed research.
Topics include Cesarean delivery and microbiome seeding, breastfeeding and human milk oligosaccharides, formula selection, probiotic use, antibiotic exposure, gut maturation, introduction of solid foods and allergens, eczema and the atopic march, food sensitivities, environmental microbial exposure, and general strategies to support infant gut health during early life.
The educational email series is informational only and does not include individualized medical advice. Participants in the limited intervention and control arms do not receive the educational email series during the active study period.
| Study group | Role | What they receive |
|---|---|---|
| Full Intervention | Experimental | Participants in the full intervention arm will receive interactive microbiome reports, coaching, personalized recommendations, and educational materials throughout the length of the study. Receives: Dietary Supplement: Tailored Recommendations; Behavioral: Consult Call; Behavioral: Educational Email Series |
| Limited Intervention Arm | Experimental | Participants in the limited intervention arm will receive simplified pdf reports with basic probiotic recommendations throughout the study. This arm has the option to participate in report interpretation calls with a Nurse Practitioner. Receives: Dietary Supplement: Tailored Recommendations; Behavioral: Consult Call |
| Control Arm | No intervention | Participants in the control arm will provide the same level of microbiome and survey data as the intervention arms but will not see their results until after the completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota Composition
Changes in gut microbiota composition, including relative abundance of beneficial bacterial taxa such as Bifidobacterium, assessed using shotgun metagenomic sequencing.
Measured: 24 months
C-Section-Associated Microbiome Signatures
Changes in the relative abundance of microbial taxa and signatures previously associated with Cesarean delivery, assessed longitudinally using shotgun metagenomic sequencing.
Measured: 24 months
Opportunistic and Potentially Pathogenic Microbial Abundance
Changes in the relative abundance of opportunistic and potentially pathogenic microbial taxa over time, assessed using shotgun metagenomic sequencing.
Measured: 24 months
Functional Microbiome Capacity
Changes in microbial functional gene pathways related to human milk oligosaccharide (HMO) digestion and short-chain fatty acid (SCFA) production, assessed using metagenomic functional profiling.
Measured: 24 months
Eczema Incidence / Atopic Symptoms
Incidence of eczema and other early atopic symptoms assessed via parent-reported surveys and standardized eczema assessment when symptoms are reported.
Measured: 24 months
Secondary outcomes (3)
HMO Digestion Functional Capacity
Changes in the abundance of microbial functional gene pathways involved in human milk oligosaccharide (HMO) digestion, assessed using shotgun metagenomic sequencing and functional gene annotation.
Unit of Measure:
Relative abundance of HMO digestion-related functional gene pathways
Measured: 24 months
SCFA Production Functional Capacity
Changes in the abundance of microbial functional gene pathways involved in short-chain fatty acid (SCFA) production, assessed using shotgun metagenomic sequencing and functional gene annotation.
Unit of Measure:
Relative abundance of SCFA production-related functional gene pathways
Measured: 24 months
Parent-Reported Infant Health Outcomes
Parent-reported infant health outcomes collected via longitudinal surveys, including gastrointestinal symptoms, infections, medication use, and feeding practices.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start31 Jan 2026
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seeding Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratory Corporation of America
- Responsible party
- Sponsor
- Investigators
- Qian Yuan, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333482
- Sponsor's protocol ID
- FLOURISH_14952
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31534227Galazzo 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 31958431Nieto 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flourish Study: A Randomized, Three-Arm Longitudinal Clinical Study of Microbiome-Guided Interventions in Cesarean-Born Infants
- ClinicalTrials.gov ID
- NCT07333482
- Acronym / sponsor ID
- FLOURISH_14952
- Conditions
- Microbiota, Gut Microbiome, Eczema, Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Seeding IncIndustry (pharma, biotech, devices)
- Collaborators
- Laboratory Corporation of America
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 12 Jan 2026 (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 whether microbiome analysis, education, and personalized recommendations can improve gut health and reduce early markers of immune-related conditions in infants aged 0-3 months delivered via Cesarean section. The study aims to determine whether these interventions can increase beneficial bacteria, decrease C-section-associated microbiome signatures, reduce opportunistic pathogens, and improve functional potential for HMO digestion and SCFA production. The study also seeks to assess whether improvements in microbiome composition are associated with a reduced prevalence of early atopic symptoms.
Researchers will compare three groups: a full intervention arm that receives microbiome reports, coaching, personalized recommendations, and educational materials; a limited intervention arm that receives simplified reports and basic recommendations; and a control arm that receives no results until study completion. This design allows evaluation of both a comprehensive intervention and a more scalable, minimal-results model.
Participants will:
- Provide six microbiome stool samples over a 24-month period.
- Provide additional small stool samples at two timepoints for exploratory metabolomic analysis.
- Receive microbiome reports and guidance according to their assigned study arm.
- Complete surveys on infant health history, symptoms, diet, and environmental exposures.
- Participate in standardized eczema assessment(s) administered by a Nurse Practitioner and evaluated by a Pediatric Allergy Specialist if any symptoms are reported.
This study seeks to demonstrate that targeted microbiome support can positively shift gut microbial development in C-section infants and may reduce risks linked to the early stages of the atopic march. Findings may inform scalable strategies for delivering microbiome-based support in early life and improve long-term health outcomes for this high-risk population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full Intervention | Experimental | Dietary Supplement: Tailored Recommendations, Behavioral: Consult Call, Behavioral: Educational Email SeriesParticipants in the full intervention arm will receive interactive microbiome reports, coaching, personalized recommendations, and educational materials throughout the length of the study. |
| Limited Intervention Arm | Experimental | Dietary Supplement: Tailored Recommendations, Behavioral: Consult CallParticipants in the limited intervention arm will receive simplified pdf reports with basic probiotic recommendations throughout the study. This arm has the option to participate in report interpretation calls with a Nurse Practitioner. |
| Control Arm | No intervention | –Participants in the control arm will provide the same level of microbiome and survey data as the intervention arms but will not see their results until after the completion of the study. |
Who may qualify
- Ages
- 0 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants are qualified for this study if they are 0 to 3 months of age at time of enrollment.
- Infants must have been delivered via Cesarean delivery (C-section), either scheduled or emergent.
- Infants must have been at least 36 weeks gestation at time of delivery.
- Infants and their caregivers must reside in the United States with a US mailing address.
Key exclusion criteria (8 listed)
- Infants can not 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 cannot have the following existing health conditions:
- Gastrointestinal conditions: Hirschsprung disease, eosinophilic gastrointestinal disorders (EGID) including 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
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 RecommendationsRecommendations are tailored to the infant's microbiome composition, functional gene profiles (e.g., HMO digestion and SCFA production pathways), age, feeding method, and reported symptoms. Guidance may include evidence-based suggestions related to probiotic use, prebiotic intake, and age-appropriate nutritional strategies intended to support healthy gut microbiome development. All recommendations are educational in nature, optional, and provided for consideration by parents or caregivers. No supplements are provided directly as part of the study, and no supplementation is required for study participation. Recommendations are updated over time as new microbiome data are collected and are delivered according to study arm assignment. The full intervention arm receives comprehensive, personalized recommendations with interpretive support, while the limited intervention arm receives probiotic recommendations only designed to model a scalable laboratory-developed test (LDT)-style approach. | Dietary supplement | Full Intervention, Limited Intervention Arm |
| Consult CallParticipants assigned to the full intervention arm will receive scheduled consult calls with a trained microbiome specialist as part of the study intervention. These are conducted remotely and are designed to support participant understanding of microbiome reports, review educational content, and discuss microbiome-informed recommendations in the context of the infant's age, feeding practices, and reported symptoms. For participants in the full intervention arm, consult calls may include discussion of microbiome-guided recommendations related to diet, supplementation, and lifestyle factors. Participants in the limited intervention arm may elect to receive a call with a licensed Nurse Practitioner for the purpose of interpreting their static microbiome report only; these calls do not include personalized recommendations or discussion of broader health symptoms. Participants in the control arm do not receive consult calls during the active study period. | Behavioural | Full Intervention, Limited Intervention Arm |
| Educational Email SeriesParticipants assigned to the full intervention arm will receive a structured educational email series delivered longitudinally over the course of the study. The email series provides evidence-based education on early infant gut microbiome development and its relationship to immune and allergic health outcomes, with links to blog articles summarizing current peer-reviewed research. Topics include Cesarean delivery and microbiome seeding, breastfeeding and human milk oligosaccharides, formula selection, probiotic use, antibiotic exposure, gut maturation, introduction of solid foods and allergens, eczema and the atopic march, food sensitivities, environmental microbial exposure, and general strategies to support infant gut health during early life. The educational email series is informational only and does not include individualized medical advice. Participants in the limited intervention and control arms do not receive the educational email series during the active study period. | Behavioural | Full Intervention |
Primary outcome
Microbiota Composition
Time frame: 24 months
Changes in gut microbiota composition, including relative abundance of beneficial bacterial taxa such as Bifidobacterium, assessed using shotgun metagenomic sequencing.
C-Section-Associated Microbiome Signatures
Time frame: 24 months
Changes in the relative abundance of microbial taxa and signatures previously associated with Cesarean delivery, assessed longitudinally using shotgun metagenomic sequencing.
Opportunistic and Potentially Pathogenic Microbial Abundance
Time frame: 24 months
Changes in the relative abundance of opportunistic and potentially pathogenic microbial taxa over time, assessed using shotgun metagenomic sequencing.
Functional Microbiome Capacity
Time frame: 24 months
Changes in microbial functional gene pathways related to human milk oligosaccharide (HMO) digestion and short-chain fatty acid (SCFA) production, assessed using metagenomic functional profiling.
Eczema Incidence / Atopic Symptoms
Time frame: 24 months
Incidence of eczema and other early atopic symptoms assessed via parent-reported surveys and standardized eczema assessment when symptoms are reported.
3 secondary outcomes
HMO Digestion Functional Capacity
Time frame: 24 months
SCFA Production Functional Capacity
Time frame: 24 months
Parent-Reported Infant Health Outcomes
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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
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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.
Qian Yuan, MD principal investigator
Massachusetts General Hospital
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 Educational Email Series in people with Microbiota and Gut Microbiome, 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberley Sukhum, PhD (512-827-9765, hello@seedinglabs.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota Composition (time frame: 24 months). The study lists 5 primary outcomes in all. 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 NCT07333482, which also lists 3 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 24 Feb 2026.