Gut Microbiome

PREVENT 1, a nationwide Swedish infant cohort for longitudinal gut microbiome profiling and early-life health outcomes: cohort profile.

TL;DR

PREVENT 1 is a nationwide prospective Swedish infant cohort established to characterise gut microbiome development during the first 2 years of life and relate microbial trajectories to feeding, infections, growth and everyday well-being, successfully recruiting 253 infants with high retention through three phases of data collection completed in December 2024.

Key Findings

PREVENT 1 successfully enrolled 253 infants nationwide in Sweden from September 2023 through targeted digital channels.

  • Eligible participants were term-born infants residing in Sweden and aged less than 1 year at enrolment
  • Recruitment occurred nationwide through targeted digital channels
  • Baseline questionnaire data and stool samples were collected from all 253 infants
  • Three-phase sample and questionnaire data collection was completed in December 2024

The cohort demonstrated high retention across all three data collection phases.

  • 248 families completing at least one follow-up questionnaire at Phase 2
  • 243 families completing at least one follow-up questionnaire at Phase 3
  • 250 infants provided at least two stool samples
  • 241 infants provided all three stool samples

At enrolment, 42.3% of infants were older than 7 months of age.

  • This reflects the age distribution at time of enrolment into the cohort
  • Infants were eligible if aged less than 1 year at enrolment
  • Data were collected at three approximately 3-month intervals for each infant

At enrolment, 73.9% of infants had weight-for-length z-scores in the normal range.

  • Weight-for-length z-scores were used as the growth metric at baseline
  • The cohort profile includes growth as one of the key health outcomes to be related to microbial trajectories

Exclusive breastfeeding at 4 months was reported for 58.9% of enrolled infants.

  • Feeding practices were captured through parental questionnaires
  • Feeding is one of the key exposures to be examined in relation to gut microbiome development
  • Parental questionnaires covered postnatal factors including infant feeding and growth

The study design integrates repeated infant stool sampling with shotgun metagenomics analysis alongside aligned parental questionnaires, stool photographs, and infant cry recordings.

  • Data collection occurred at three approximately 3-month intervals for each infant
  • Shotgun metagenomics was used for microbiome profiling
  • Questionnaires covered socio-demographic characteristics and health, pregnancy and delivery, postnatal factors, infant environment, feeding and growth, infections and other health outcomes, gastrointestinal symptoms and everyday well-being
  • Stool photographs and infant cry recordings were collected as additional data streams

Future analyses are planned to examine microbiome features, resistome profiles and functional pathways in relation to antibiotic exposure, feeding, growth and infant health outcomes.

  • Resistome profiling is included as a planned analytical component
  • Antibiotic exposure is a key planned exposure of interest
  • Subject to ethical approval and participant consent, follow-up may include further stool collection and Swedish register linkage
  • The cohort is registered under NCT06285630

What This Means

This research describes the setup and baseline characteristics of PREVENT 1, a large Swedish study tracking how bacteria in babies' guts develop during the first two years of life. Researchers recruited 253 babies from across Sweden and collected poop samples along with detailed questionnaires from parents at three time points spaced roughly three months apart. The study also gathered stool photographs and recordings of babies crying. Analysis of the poop samples uses advanced DNA sequencing to identify all the microorganisms present, not just specific ones. Nearly all families who enrolled stayed in the study through all three collection phases, which is considered very high retention for this type of research. At the start of the study, the researchers recorded that about 59% of babies had been exclusively breastfed up to 4 months of age, and about 74% had normal weight-for-length measurements. Parents answered detailed questions about pregnancy, birth, feeding, infections, gut symptoms, and general well-being. These baseline characteristics help describe who is in the study and will allow future researchers to account for differences between families when analyzing results. This research matters because the community of microorganisms living in a baby's gut during early life may have lasting effects on health, including risk of infections, growth, and well-being. By following a large group of babies over time and combining microbiome data with detailed health information, this cohort will help scientists understand how factors like breastfeeding, antibiotic use, and diet shape the gut microbiome — and how those microbial patterns connect to health outcomes. The researchers also plan to link study data to Swedish national health registers and to analyze antibiotic resistance genes found in the babies' gut bacteria, which could have broader public health relevance.

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Citation

Orwa S, Vlajic M, Cavani E, Devall A, Hugerth L, Brusselaers N, et al.. (2026). PREVENT 1, a nationwide Swedish infant cohort for longitudinal gut microbiome profiling and early-life health outcomes: cohort profile.. BMJ open. https://doi.org/10.1136/bmjopen-2026-118233