The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares
Starting soon · Not applicable
Conditions studied: Inflammatory Bowel Disease
In brief
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.
Key facts
- Study ID
- NCT07143188
- Run by
- Wake Forest University Health Sciences
- People needed
- 42
- Starts
- 2026-09-01
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- adults with an established diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease) who are being treated in the outpatient setting for an Inflammatory bowel disease (IBD) flare, defined as a clinically significant increase in IBD symptoms (e.g., abdominal pain, nausea, vomiting, diarrhea, joint pain, fever, bleeding, unintended weight loss).
You may not qualify if…
- Patients requiring admission to the hospital for treatment of a flare
- Patients with allergies to any ingredients in the mBIOTA Elemental Diet
- Female patients who are pregnant
- Patients with diabetes who are taking insulin as part of their treatment plan
- Patients with other medical conditions or personal preferences that would compromise their ability to adhere to the elemental study
Where it is running
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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