Status:
NOT_YET_RECRUITING
The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
mBIOTA
Conditions:
Inflammatory Bowel Disease
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 Un...
Detailed Description
Enteral nutrition (EN) has shown promise in treating IBD and has the theoretical benefit of reducing symptoms and increasing quality of life while avoiding the side effects associated with standard ph...
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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT07143188
Start Date
January 1 2026
End Date
May 1 2026
Last Update
October 30 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157