IBD endpoints combine what participants record at home, such as stool frequency and bleeding, with endoscopy read centrally. Capture runs the daily diary on participants' phones and keeps visit, endoscopy and lab data in the same study.
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Daily bowel diary
Monday · Day 5 of 7 before Week 8 visit
Number of stools today
Blood in stool
Worst abdominal pain today
What matters in GI and IBD trials
Study design
Mayo stool frequency and rectal bleeding subscores, CDAI and PRO2 are calculated from daily diary entries over a defined number of days before a visit, often the three most recent valid days out of the seven before the visit, excluding days affected by bowel preparation or endoscopy. If participants forget to fill in the diary, or fill it in retrospectively, the visit score is unreliable or missing.
That makes the diary schedule as important as the visit schedule. Daily entries with completion windows, reminders and a clear view of which participants are missing days before an upcoming visit let sites intervene in time. The stool frequency subscore is also relative to each participant's normal frequency, which must be recorded at baseline.
Record the procedure date, preparation quality and local read on a site form, and the central read result when it arrives. Keeping local and central reads as separate variables shows where they disagree and makes it clear which one the endpoint uses.
| Assessment | Scr | BL | W2 | W4 | W8 | W12 |
|---|---|---|---|---|---|---|
| Daily diary | D | D | D | D | D | D |
| Endoscopy (central read) | ||||||
| Physician global assessment | ||||||
| Labs (CRP, faecal calprotectin) | ||||||
| IBD quality of life |
D = daily diary entries
Daily diary
Participants complete a short diary each evening from a secure link on their phone, with no app. Completion windows stop back-filling, a reminder ladder prompts missed entries while respecting quiet hours, and the dashboard flags at-risk participants so sites can call before diary days are lost.
When due
18:00
Your evening diary is open
Next day
18:00
Reminder: your diary is still open
Final notice
21:30
Last chance before the window closes
Quiet hours
22:00 to 08:00 in the participant's time zone
Stops
As soon as the task is completed
Try the diary on your phone in the free sandbox.
Endpoints
| Condition | Endpoint | Components |
|---|---|---|
| Ulcerative colitis | Modified Mayo score, clinical remission | Stool frequency and rectal bleeding (diary), endoscopic subscore (central read) |
| Ulcerative colitis | Histological and endoscopic improvement | Biopsy histology scores and endoscopy |
| Crohn's disease | PRO2 remission and endoscopic response | Stool frequency and abdominal pain (diary), SES-CD (central read) |
| Crohn's disease | CDAI | Seven-day diary items, clinical findings, haematocrit, body weight |
| IBS | Weekly composite responder | Daily abdominal pain and stool consistency or bowel movements |
Definitions vary by protocol and regulator. Write the exact derivation rules in the analysis plan.
Biomarkers and safety
Faecal calprotectin and C-reactive protein track inflammation between endoscopies and are common secondary endpoints. Record them with units, sample dates and the laboratory, because calprotectin assays differ. Stool testing for infection, particularly Clostridioides difficile, is usually required at screening and during flares, since infection can mimic a flare.
Immunosuppressive treatments also need safety labs and infection monitoring. A lab table with reference ranges and range checks keeps repeated values consistent across sites. See the lab results eCRF template.
Study build
Which days count, exclusions for bowel preparation.
Recorded for the stool frequency subscore.
Local and central reads as separate variables.
Scheduled if part of the score.
Calprotectin and CRP with assay details.
Stool tests at screening and flares.
A score for ulcerative colitis made up of stool frequency, rectal bleeding and endoscopic subscores, each 0 to 3.
A patient-reported measure combining stool frequency and abdominal pain from daily diaries, used with endoscopic response as co-primary endpoints.
Key endpoints are calculated from diary entries in the days before each visit, so missing days affect the score.
Usually, by blinded central readers. Local and central reads should be kept as separate variables.
No. The diary opens in the phone browser from a secure link.
Yes, in the free sandbox with every feature.
Daily diaries with windows and reminders. Free sandbox.