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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Sample collection for IBS

Aim: More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.

Official registry: https://clinicaltrials.gov/study/NCT02421705 · KU Leuven · enrollment listed as 99,999,999

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Sample collection. The registry lists allocation as na. Aim: More insight in pathogenesis of IBS and IBD.

They plan to enroll about 99,999,999 people at Leuven. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Visceral Sensitivity in IBD and IBS: Role of Inflammation, Immune Activity and Genetic Factors

Interventions: Sample collection

Primary outcome (registry wording): differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • Irritable Bowel Syndrome (IBS) (ROME III criteria)
  • No obvious organic explanation for the IBS symptoms
  • Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
  • Group 2: active ulcerative colitis 1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy) 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study
  • Group 3: ulcerative colitis in remission (3a: with IBS symptoms, 3b: without IBS symptoms)
  • diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy)
  • remission is confirmed by at least one sigmoidoscopy

Public study contact (from the registry)

Koen Bellens, MSc

0032-16-341943

koen.bellens@kuleuven.be

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT02421705 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT02421705?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT02421705?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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