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Discovery

Westlake Frequent-sampling Cohort 2

Hypothesis
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Editor's note
Distinguishing which microbiome changes matter clinically requires knowing what stability actually looks like in individuals over years—not weeks. This prospective follow-up directly addresses a foundational gap: whether the short-term variability patterns we observe persist or dampen, and where a true "core" microbiome ends and noise begins. Gastroenterologists, microbiome researchers, and FMT practitioners should track this study's longitudinal architecture, as it will calibrate how we interpret dysbiosis and engraftment trajectories in clinical populations.

Source: ctgov · Westlake University · RECRUITING · 2026-05-26

URL: https://clinicaltrials.gov/study/NCT07606885

AI rationale (4/5, tier: emerging): Longitudinal cohort tracking gut microbiome stability/dynamics over multiple timescales; matches INCLUDE priority for longitudinal human cohorts and colonisation dynamics.


This observational follow-up study extends a previously completed 15-day intensive longitudinal study (WeF) of the gut microbiome in healthy adults. The objective of WeF2 is to characterize the long-term stability and dynamics of the gut and oral microbiota in the same cohort across multiple timescales, and to determine whether the day-to-day variability patterns observed at baseline persist over months and years. Participants who completed the WeF baseline protocol will be invited to attend periodic follow-up visits for low-frequency biospecimen collection and to repeat the original 15-day high-frequency sampling protocol at planned intervals, beginning approximately six months after the WeF baseline and continuing at extended intervals thereafter. By combining sparse routine sampling with recurring high-density sampling windows, the study aims to distinguish the stable core microbiome from transient and seasonal fluctuations, to track gradual community shifts under free-living condit

🔬 Deep dive

Plain-language summary

The Westlake Frequent-sampling Cohort 2 (WeF2) is an observational follow-up study that re-enrolls healthy adults who previously completed a 15-day intensive gut microbiome sampling study (WeF) at Westlake University in China. The core idea is to understand not just what your gut microbiome looks like on any given day, but how stable or variable it is across months and years of normal life. Participants will return for periodic low-frequency sample collections and will also repeat the intensive 15-day daily-sampling protocol at intervals beginning roughly six months after the original baseline. By layering sparse routine sampling on top of recurring high-density windows, the study can tease apart the 'stable core' microbiome from fluctuations driven by season, diet, illness, or other life events. This design is methodologically important because most microbiome studies take just one or two snapshots, making it impossible to know whether an observed community is typical for that person or a transient state. WeF2 aims to determine whether short-term day-to-day variability patterns identified at baseline are reproducible features of an individual's microbiome years later. If they are, it would validate short intensive sampling bursts as a reliable 'fingerprint' of personal microbiome dynamics—a finding with broad implications for clinical microbiome testing and research design.

Key findings

  • No results are yet available — the study is actively recruiting as of May 2026; all findings below reflect study objectives, not outcomes.
  • Primary objective: determine whether day-to-day gut microbiome variability patterns observed during the original 15-day WeF protocol persist and are reproducible over multi-year follow-up under free-living conditions.
  • Secondary objective: distinguish a stable 'core' personal microbiome from transient or seasonally driven community fluctuations by combining sparse longitudinal sampling with repeated high-density 15-day sampling windows.

Methods + cohort

WeF2 is a prospective observational longitudinal cohort study enrolling adults who completed the prior WeF baseline protocol (15 consecutive days of daily stool and oral biospecimen collection). Follow-up visits are designed at extended intervals (starting ~6 months post-baseline and continuing thereafter), with each interval including both sparse routine biospecimen collection and a repeat of the full 15-day intensive daily-sampling protocol. No intervention is administered; participants continue free-living conditions throughout. Sample size and exact visit schedule are not disclosed in the available registration metadata, and the study is currently in the recruiting phase with an estimated completion horizon extending to at least 2026.

Limitations + open questions

Because this is an observational study of a single previously assembled healthy-adult cohort, findings may not generalise to other populations, age groups, or disease states. Retention bias is a significant concern in multi-year longitudinal designs: participants who remain in the study through repeated intensive sampling windows may differ systematically from those lost to follow-up, potentially inflating estimates of microbiome stability. The study cannot establish causality between microbiome dynamics and any health outcome, nor can it determine whether identified stability patterns are driven by host genetics, diet, geography, or their interaction. A natural next experiment would pair WeF2's observational trajectory data with a controlled dietary or antibiotic perturbation to test whether the stable core microbiome is resilient or merely quiescent.

How this fits the corpus

WeF2 directly extends the methodological framework interrogated in [§100], which argues that human microbiome research needs ecological and causal longitudinal designs to move beyond cross-sectional snapshots—WeF2's repeated high-density sampling windows represent a practical implementation of that framework. It parallels [§75], which also tracks gut microbial colonisation dynamics over time but in a very different population (infants rather than healthy adults), making the two studies jointly informative about the timescales over which microbiome stability is established and maintained across the lifespan. The study also runs parallel to [§72], which characterises microbiota remodelling trajectories in obese patients after bariatric surgery; comparing those procedure-induced community shifts against the natural free-living drift captured in WeF2 will help calibrate what magnitude of change is clinically meaningful versus within normal individual variation. Finally, WeF2's oral microbiota component offers a point of comparison with [§86], where integrated metagenomic signatures are linked to cognitive outcomes, since oral-gut microbial co-dynamics remain poorly characterised in healthy longitudinal cohorts.

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AI-generated summary using claude-sonnet-4-6 on 2026-07-06. Information, not medical advice.
Published 2026-05-28 · Last kit-update 2026-05-28