The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares
Not applicable · Testing elemental diet (ED) · 1 site · Wake Forest University Health Sciences
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing elemental diet (ED) (a dietary supplement) as supportive care (to help with symptoms or quality of life). Condition(s) listed: Inflammatory Bowel Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 21 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 42 participants are expected to take part.
- The study has 2 groups.
- Start date: 2026-12 (planned).
- Main results expected around 2027-07 (estimate from the record).
- 1 study site listed in United States.
Groups in this study
- elemental diet (ED) (listed as: experimental group)
- control group (listed as: no-intervention group)
Main thing being measured
- change of symptom burden scores (Week 1 to Week 12)
In the researchers’ words
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…
Words you might see
- Pruritus: itching; a common and often hard-to-treat symptom in cholestatic liver disease.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease |
| Lead sponsor | Wake Forest University Health Sciences |
| Collaborators | mBIOTA |
| Enrollment | 42 (estimated) |
| Start date | 2026-12 |
| Primary completion (est.) | 2027-07 |
| First posted | 2025-08-27 |
| Last updated | 2026-09-28 |
| Official title | Elemental Diet as an Adjunctive Therapy for Inflammatory Bowel Disease Flares The EDICT Trial |
| ClinicalTrials.gov ID | NCT07143188 |
Interventions
- elemental diet (ED) (Dietary Supplement)
mBIOTA is a palatable elemental diet formulation
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Criteria: * 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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem, North Carolina | United States |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.