NCT07143188Not yet recruiting
The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares
Elemental Diet as an Adjunctive Therapy for Inflammatory Bowel Disease Flares The EDICT Trial
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 19 Aug 2025
- Start date
- Dec 2026
- Primary completion date
- Jul 2027
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07143188
What you commit to
- Study type: Interventional
- Planned participants: 42
- From Dec 2026 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Patients requiring admission to the hospital for treatment of a flare
- Female patients who are pregnant
Who the study is looking for
- 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).
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.