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Investigating Serotonin Signalling in IBD Patients

Study acronym: IBD
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later May 2026 → Nov 2027
See other at-risk trials from McMaster University

Record History

  1. Primary and study completion pushed from May 2026 to Nov 2027 Publications: details revised at 35 of 38 entries · Eligibility criteria expanded, about 4 words Show 2 more changesShow less
    • Publications: details revised at 35 of 38 entries
    • Eligibility criteria expanded, about 4 words
  2. Primary and study completion dates: May 2025 to May 2026v12
  3. Primary endpoint revisedv11 See this version in full on ClinicalTrials.gov ↗
  4. Primary and study completion dates: May 2024 to May 2025 Secondary endpoints: details revised at 1 of 1 entryv10 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 1 entry
  5. Primary and study completion dates: May 2022 to May 2024v9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary and study completion dates: May 2021 to May 2022v8
  2. Primary and study completion dates: May 2020 to May 2021v7
  3. Trial status: Active, Not Recruiting to Recruiting Primary and study completion dates: May 2019 to May 2020 · Site details revisedv6 Show 2 more changesShow less
    • Primary and study completion dates: May 2019 to May 2020
    • Site details revised
  4. Primary and study completion dates: May 2018 to May 2019v5
  5. Primary and study completion dates: May 2016 to May 2018 Primary endpoint revised · Secondary endpoints: 2 to 1 · Study description expanded, about 195 wordsv4 Show 3 more changesShow less
    • Primary endpoint revised
    • Secondary endpoints: 2 to 1
    • Study description expanded, about 195 words

    See this version in full on ClinicalTrials.gov ↗

  6. Primary and study completion dates: May 2013 to May 2016 Trial status: Recruiting to Active, Not Recruiting · Site details revisedv3 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
  7. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Alterations in normal serotonin (5-hydroxytryptamine;5-HT) signaling have been reported in ulcerative colitis (UC) and Crohn's disease (CD). Studies report an increase in enterochromaffin (EC) cell, main source of 5-HT in the gut, numbers in CD and UC patients. Up-regulated expression of mucosal Tryptophan hydroxylase (TPH)-1, catalytic enzyme in 5-HT production, messenger RNA (mRNA) have been found in CD patients in remission who are suffering the irritable bowel syndrome (IBS)-like symptoms. Alterations in normal 5-HT signaling has also been reported in animal models of inflammatory bowel disease (IBD). Thus, the aim of the proposed research project will be to study the alterations in 5-HT signalling accompanying GI inflammatory conditions, such as IBD.
Trial Details
NCT Number NCT01650311
Lead Sponsor McMaster University
Conditions Inflammatory Bowel Disease
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov