The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07143188
Status
Not Yet Recruiting

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Conditions

  • Inflammatory Bowel Disease

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • elemental diet (ED) — DIETARY_SUPPLEMENT
    mBIOTA is a palatable elemental diet formulation

Study Details

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 Dates

Start date
Aug 31, 2026
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: elemental diet (ED)
    The intervention in this study will be an elemental diet (ED) formulation produced by mBIOTA. All patients randomized to the ED arm will receive a two-week supply (84 servings + additional packets as needed) of the "original" flavor mBIOTA elemental diet.
  • No Intervention: control group
    Patients randomized to the control group will undergo counseling with a registered dietician for general dietary advice but will be instructed to continue their usual diet, as tolerated, without any restrictions.

Primary Outcome Measure

change of symptom burden scores [ Time Frame: Week 1 to Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Bradley Joseph, MD
[email protected]
703-463-1287
Richard B Weinberg, MD
[email protected]
704-355-2000

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By research site
Wake Forest University Health Sciences· Winston-Salem, NC

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