Tests an elemental diet as added treatment for inflammatory bowel disease flares
Tests a liquid elemental diet alongside usual care in adults with inflammatory bowel disease flares.
Plain-language title generated from the registry record
Registry title: The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares
Key facts
- Where
- Winston-Salem, United StatesSee the site
Where in United States
- Wake Forest University Health SciencesWinston-Salem, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Wake Forest University Health Sciences
- Trial code
- NCT07143188
- Record updated
- 28 September 2026
- Original description
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.Read full original descriptionShow less
Elemental Diet as an Adjunctive Therapy for Inflammatory Bowel Disease Flares The EDICT Trial
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.
Inclusion: 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).
Exclusion: Patients with allergies to any ingredients in the mBIOTA Elemental Diet; 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; Patients requiring admission to the hospital for treatment of a flare; Female patients who are pregnant.