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The EDICT Trial: Elemental Diet for Inflammatory Bowel Disease Flares

This study is looking at a special liquid diet called mBIOTA (an elemental diet) to help adults experiencing a flare-up of Inflammatory Bowel Disease (IBD), which includes Crohn's disease and ulcerative colitis. IBD flares cause symptoms like abdominal pain, diarrhea, and weight loss. While standard treatments can help, they sometimes have side effects. This trial aims to see if mBIOTA can reduce your symptoms over 12 weeks. You may be able to join if you are an adult with IBD who is currently having a flare and receiving outpatient care. The study plans to enroll 42 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 42 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants' symptom burden scores will be measured from Week 1 to Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07143188

The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares

Not Yet Recruiting
NAAges 21+InterventionalSupportive care
Wake Forest University Health Sciences
~42 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:elemental diet (ED)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
change of symptom burden scores
Measured over Week 1 to Week 12

Conditions

Inflammatory Bowel Disease

Explore related trials

Crohn DiseaseUlcerative Colitis

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Richard B Weinberg, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Bradley Joseph, MD
[email protected]
703-463-1287
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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 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

What this trial measures

  • change of symptom burden scoresWeek 1 to Week 12

    assessed by the symptom severity survey - collecting all data using the same survey for both Crohn's disease and ulcerative colitis patients. the Simple Clinical Colitis Activity Index (SCCAI) ranges from 0-19. For both scores, lower means less disease activity and therefore "better." the Harvey-Bradshaw Index (HBI) - Based on convention, a total HBI score of \<5 indicates remission, 5-7 suggests mild severity, 8-16 denotes moderate severity, and ≥16 demarks severe disease.