Elemental Diet as an Adjunctive Therapy for Inflammatory Bowel Disease Flares The EDICT Trial
Wake Forest University Health Sciences
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 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.
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 pharmacotherapy. Exclusive EN has even proven superior to steroids for induction of remission in CD in pediatric patients. Unfortunately, the same effect has not been seen in adults, but a Chochrane metaanalysis showed no significant difference in remission rates between steroids and exclusive EN for treatment of CD. Notably, however, EN studies are notoriously hindered by small group sizes and limi…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 * Pati…
Interventions
- Dietary Supplementelemental diet (ED)
mBIOTA is a palatable elemental diet formulation
Location
- Wake Forest University Health SciencesWinston-Salem, North Carolina