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The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares

Study acronym: EDICT
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later across 2 updates Dec 2026 → Jul 2027
See other at-risk trials from Wake Forest University Health Sciences

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Sep 2026 to Dec 2026 Show 4 more changesShow less
    • Primary completion pushed from Jan 2027 to Jul 2027
    • Study completion pushed from Apr 2027 to Jul 2027
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 5 of 7 entries
  2. Primary completion pushed from Dec 2026 to Jan 2027
    • Study completion pushed from Dec 2026 to Apr 2027
    • Start date: Aug 2026 to Sep 2026
    v7
  3. Start date: Apr 2026 to Aug 2026
    • Primary completion pushed from Jun 2026 to Dec 2026
    • Study completion pushed from Aug 2026 to Dec 2026
    v6
  4. Study completion date: Jun 2026 to Aug 2026
    • Start date: Mar 2026 to Apr 2026
    v5
  5. Start date: Feb 2026 to Mar 2026v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary and study completion dates: May 2026 to Jun 2026
    • Start date: Jan 2026 to Feb 2026
    v3
  2. Start date: Oct 2025 to Jan 2026
    • Primary completion date: Apr 2026 to May 2026
    • Study completion date: Jul 2026 to May 2026
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic inflammatory conditions of the gastrointestinal tract that affect millions of people in the United States of America. Among patients with IBD, symptomatic flares are quite common; up to 40-50% of patients in some populations report having a flare at least once per month. For most patients with IBD flares, the typical outpatient treatment consists of corticosteroids and, in some instances, initiation of or switching between 5-aminosalicylic acid-acid preparations, immunomodulators, or biologics. These treatments, while often effective, can have harmful side effects, especially when used for long durations of time. Therefore, alternative treatments are highly sought after by both patients and providers.
Trial Details
NCT Number NCT07143188
Lead Sponsor Wake Forest University Health Sciences
Collaborators: mBIOTA
Conditions
(from sponsor)		 Inflammatory Bowel Disease
Related terms Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov