Use case · Microbiome studiesUpdated October 11, 2026

Microbiome clinical study data capture

A microbiome study is only as interpretable as its metadata. Antibiotics, diet, stool form, symptoms and exact sample timing all change the sequencing result. Capture records them next to the clinical outcome in one study with one audit trail. Test it free, no credit card.

  • Sample collection records
  • Antibiotic and diet metadata
  • Stool and symptom diaries

Free sandbox · No credit card · 21 CFR Part 11 aligned

Sample metadata completeness (demo cohort)

Samples logged

96

Metadata complete

91%

  • Collection date and time recorded96 of 96
  • Antibiotic exposure confirmed94 of 96
  • Diet questionnaire within window88 of 96
  • Stool form recorded90 of 96
  • Storage step documented5 queries open
Demo data only. Missing items become queries, so gaps are chased before sequencing.

What a microbiome study needs from its data capture

  • The clinical record next to the sample: the sample identifier, collection date and time, and the clinical context belong in one system, so a sequencing result can be linked back to a participant visit.
  • Confounders recorded, not assumed: recent antibiotics, probiotics, diet, bowel habits and medicines all shift the microbiome and are routinely collected as metadata.
  • Participant-collected samples: many studies send kits home, so the participant records when and how the sample was taken.
  • Diet and stool diaries between visits: a short phone diary captures food, stool form and symptoms near the time of sampling.
  • A clean hand-off to bioinformatics: the sequencing and analysis happen elsewhere, so a clear identifier and exportable metadata are the contract.

The study data

What microbiome studies collect, and where the data goes wrong

Microbiome studies run from observational cohorts to randomised trials of probiotics, prebiotics, diets, fecal microbiota transplantation and live biotherapeutic products. Their outcomes mix a laboratory readout, such as taxonomic composition from 16S or shotgun sequencing, with clinical outcomes such as symptom scores, stool frequency or disease activity. The analysis then asks whether the community changed, and whether the change tracks the clinical result. Neither question can be answered without careful metadata. Published work shows how much is at stake: observational studies record current and previous antibiotic use for a year or more before sampling, adjust for demographics and other exposures, and trial protocols track stool frequency and form through participant diaries alongside 16S profiling.

The failure mode is missing or late metadata. Antibiotic history is hard to reconstruct afterwards, and one study that profiled stool chemistry found medicines that the records had never listed. A diet questionnaire done a month after sampling describes a different diet. In Capture, each of these is a structured form with required fields, a window around the sample date and edit checks that raise an automatic query when a value is missing or out of range. The audit trail records who entered what, the old value, the new value and the reason for any change, which matters when metadata is corrected after the first look at the sequence data.

Microbiome studies also tend to be small to medium, often run by biotech startups, academic groups or nutrition teams without a large data management group. The self-serve build, where you can upload a protocol and let the AI study builder draft visits and forms for you to review, suits that setting; see clinical trial software for nutrition research and clinical trial software for biotech founders.

Sample records and the hand-off to the lab

Capture is an electronic data capture system, not a laboratory information system. Record the sample identifier, collection date and time, who collected it, whether it was participant or staff collected, the kit used, any deviation from the instructions and the storage step you want documented, as fields on a visit form with a repeating row for each sample. Sequencing, freezer inventory and bioinformatics stay in your lab systems; the shared key is the sample identifier. Exports are available as CSV and Excel with an automatic data dictionary, and as CDISC SDTM datasets in SAS XPT format with Define-XML where your submission needs them; see CDISC SDTM export and exporting EDC data to R, SAS and SPSS.

Stool sample collection record (demo)
Participant 001-0042 · Visit 2 (Week 4)Draft

Sample

Sample ID

SAMPID
S-0042-02

Collected by

COLBY
Participant at homeSite staff

Collection date and time

COLDTC
2026-10-02 07:40

Antibiotics in the past 30 days

ABX
NoYes

Yes: record drug, start and stop dates

Stool form

STOOLFORM
1234567
Demo data only. Fake IDs.Save
Conditional logic opens the antibiotic detail fields only when the answer is Yes.

Protocol to build

Microbiome study elements and how they map to Capture

Protocol elementWhat the data looks likeWhere it lives in Capture
Eligibility and exclusionsRecent antibiotics, GI disease, diet restrictionsEligibility screening template with skip logic
Antibiotics and medicinesDrug, start and stop dates, indicationConcomitant medications template
Sample collectionID, date and time, collector, deviationsRepeating-row visit form; sample ID is the key for the lab
Stool formSeven-category type per stoolBristol stool scale template
DietRecall or frequency questionnaire24-hour recall form, food frequency form
SymptomsGI symptom ratings between visitsGI symptoms diary on the phone
Product useDoses taken, doses returnedMedication adherence and pill count
Adverse eventsOnset, severity, seriousness, relationshipAdverse event form

Scale and questionnaire wording is yours to supply. Licensed instruments stay with your study documents; Capture does not supply or verify instrument licences.

Build your sample record and metadata forms in the sandbox

Describe the form or upload the protocol, let the AI draft it for you to review, and enter sample data. Free sandbox, no credit card.

Build your microbiome study free

Design variants

Cohorts, supplements, GI disease and biobanking

Probiotic and dietary supplement trials emphasise adherence and product accountability alongside the sample. Tablets or sachets taken, doses returned and any deviation from the dosing instructions are recorded on a form, and the nutraceutical trials and supplement trials pages cover the pattern. For investigational products, the IMP inventory and drug accountability page describes how dispensing and returns are tracked.

Gastrointestinal disease programmes link the microbiome to a clinical endpoint. EDC for IBS clinical trials and EDC for gastroenterology and IBD trials describe the symptom diaries and scores that sit beside stool samples. In those designs the sample is one data stream among several, and keeping it in the same study as the symptom score avoids a spreadsheet merge at the end.

Where samples or data may be reused beyond the original study, consent matters. eConsent templates for biobank and repository and genomic research show the structure for broader use; the wording must be approved by your ethics committee. Because Capture supports a participant signature with email one-time code and investigator countersignature, with each signature linked to the exact document, the consent record travels with the study data. Roles and PII segregation mean the lab sees coded IDs and sample numbers, not participant names; see the product page for eConsent.

Build sequence

From microbiome protocol to a live study

A practical order of work for a biotech or academic team.

  1. 1

    List the confounders

    Decide which exposures you must record and the look-back period for each, such as antibiotics and probiotics.

  2. 2

    Draft visits and forms

    Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose visits and forms. Nothing is saved until a person reviews it.

  3. 3

    Build the sample form

    Sample ID, collection date and time, collector, kit, deviations and storage step, with required fields and edit checks.

  4. 4

    Add diaries

    Stool, diet and symptom diaries on the participant phone, with reminders and a completion window.

  5. 5

    Test the lab hand-off

    Export sample metadata keyed on sample ID and open it with the bioinformatics team.

  6. 6

    Approve and go live

    Approved forms lock for live use. Real participants start the paid live phase.

Before first participant

Microbiome study readiness checklist

Sample ID scheme agreed

One identifier format shared by the EDC, kit labels and the lab.

Metadata windows defined

How close to sampling diet and symptom data must be collected.

Antibiotic rule written

Exclusion window and how exposure after enrolment is recorded.

Consent scope approved

Sample reuse, sharing and storage wording reviewed by the ethics committee.

Export tested

CSV or Excel with the data dictionary opened by the analysts.

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

Does Capture store sequencing data?

No. Capture is an electronic data capture system for clinical and sample metadata. Sequencing files and bioinformatics stay in your lab systems, linked by the sample identifier.

Can participants record when they collected a sample?

Yes. A phone task or home-collected sample form can record date, time and deviations, with reminders and a completion window.

Can it track antibiotics and other medicines?

Yes. Use a concomitant medications form with start and stop dates and indication, plus conditional questions that ask for detail only when the answer is yes.

What export formats are available?

CSV and Excel with an automatic data dictionary, and CDISC SDTM datasets as SAS XPT files with Define-XML.

Is it suitable for a randomised probiotic trial?

Yes. Capture includes randomisation, blinded roles, adherence capture and adverse event reporting, and is suitable for Phase 1, 2 and 3 studies.

How much does it cost?

The sandbox is free with every feature, no credit card and no time limit. You pay only once you go live with real participants. Pricing is not published on the site, so ask for terms for your study via the demo page or the pricing page.

Start building your microbiome study free

Free sandbox with every feature. No credit card, and you pay only when you go live.

Build your microbiome study free