Evidence map›Paper›PMID 40898384›Full record

Trial reportPediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology2025

Improving immune-related health outcomes post-cesarean birth with a gut microbiome-based program: A randomized controlled trial.

Pamela A Nieto, Claudia Nakama, Julian Trachsel, David Goad, Taylor K Soderborg, Danielle Shea Tan, Amy Orlandi, Qian Yuan, Elisa Song, Noel T Mueller and 3 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06424691 naunknown statusnot on this map

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

TypeinterventionalSponsorSeeding IncRan2023 to 2025Enrolled100ConditionsMicrobiota, Eczema, Microbiome, Gut MicrobiomeArmsTailored Recommendations, Consult Call, Email Series
NCT07333482 narecruitingnot on this mapstarted 2026, after this paper: background citation

Flourish Study: A Randomized, Three-Arm Longitudinal Clinical Study of Microbiome-Guided Interventions in Cesarean-Born Infants

TypeinterventionalSponsorSeeding IncRan2026 to 2028Enrolled250ConditionsMicrobiota, Gut Microbiome, Eczema, MicrobiomeArmsTailored Recommendations, Consult Call, Educational Email Series
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Improving immune-related health outcomes post-cesarean birth with a gut microbiome-based program: A randomized controlled trial.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2025
    Trial
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Pamela A NietoSeeding Inc, Doing Business as Tiny Health, Austin, Texas, USA.ORCID https://orcid.org/0009-0003-2157-0272
Claudia NakamaSeeding Inc, Doing Business as Tiny Health, Austin, Texas, USA.
Julian TrachselSeeding Inc, Doing Business as Tiny Health, Austin, Texas, USA.ORCID https://orcid.org/0000-0003-2357-7737
David GoadSeeding Inc, Doing Business as Tiny Health, Austin, Texas, USA.
Taylor K SoderborgSeeding Inc, Doing Business as Tiny Health, Austin, Texas, USA.
Danielle Shea TanSeeding Inc, Doing Business as Tiny Health, Austin, Texas, USA.
Amy OrlandiSeeding Inc, Doing Business as Tiny Health, Austin, Texas, USA.
Qian YuanFood Allergy Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-8639-835X
Elisa SongWhole Family Wellness, Belmont, California, USA.
Noel T MuellerDepartment of Pediatrics, Section of Nutrition, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Ruben A MarsSeeding Inc, Doing Business as Tiny Health, Austin, Texas, USA.
Cheryl Sew HoySeeding Inc, Doing Business as Tiny Health, Austin, Texas, USA.
Kimberley V SukhumSeeding Inc, Doing Business as Tiny Health, Austin, Texas, USA.

Funding

Seeding Inc. DBA Tiny Health
6 · The paper itself

Abstract

backgroundInfants born via Cesarean section (C-section) often have a distinct gut microbiome and higher risks of atopic and immune-related conditions than vaginally delivered infants. We evaluated whether a microbiome-based program could shift gut microbiome composition and improve microbiome-associated health outcomes in C-section born infants.

methodsThis open-label, randomized, controlled trial included full-term C-section-born infants aged 0-3 months, randomized to an intervention (n = 25) or control arm (n = 29). Over 6 months, the intervention arm received two microbiome reports, personalized recommendations based on their microbiome, educational materials, and coaching calls focused on microbiome health. Parents reported health conditions via surveys. PRIMARY OUTCOME: Difference between study arms in relative abundance of key gut microbiome taxa and functional genes. Other outcomes: Changes in a C-section index-a taxonomy-based metric comparing C-section-associated taxa to vaginally-associated taxa-and prevalence of atopic conditions.

resultsCompared to controls, the intervention arm had higher Bifidobacterium (p = .025, q = .121) and higher abundance of genes associated with human milk oligosaccharide degradation (e.g., α-L-fucosidase, p = .019, q = .046) at timepoint 2. In the intervention arm, the C-section index decreased to a level similar to vaginally born infants (p = .807, q = .807). At the end of the intervention, atopic dermatitis prevalence was lower in the intervention arm than in controls (odds ratio, 0.17 [95% CI, 0.023-0.723], p = .031).

conclusionA personalized microbiome-based program can modulate the gut microbiome of C-section-born infants and may reduce the risk of atopic conditions (ClinicalTrials.gov: NCT06424691).

Indexed as

Cesarean SectionGastrointestinal MicrobiomeFemaleHumansInfantInfant, NewbornMalePregnancyatopic dermatitisbifidobacteriumcesarean sectiongutinfant gutmicrobiome

Identifiers

PMID40898384
PMCPMC12405607

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.