Elemental Diet as an Adjunctive Therapy for Inflammatory Bowel Disease Flares The EDICT Trial

Official 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.

Eligibility Requirements

• Minimum Age: 21 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 42 participants

Study Arms

• elemental diet (ED) (EXPERIMENTAL)
  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.
• control group (NO_INTERVENTION)
  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.

Interventions

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

Primary Outcomes

• change of symptom burden scores (Week 1 to Week 12)

Secondary Outcomes

• changes in inflammatory markers - Erythrocyte Sedimentation Rate (ESR) (Baseline, Weeks 2 and 4)
• changes in inflammatory markers - C-reactive protein (CRP) (Baseline, Weeks 2 and 4)
• changes in inflammatory markers - fecal calprotectin (Baseline, Weeks 2 and 4)
• changes in nutritional status - Prealbumin (Baseline, Weeks 2 and 4)
• changes in nutritional status - Bioelectrical Impedance Analysis score (Baseline, Weeks 2 and 4)

Eligibility Criteria

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

Trial Locations

• Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Contact Information

• Bradley Joseph, MD — CONTACT
  Phone: 703-463-1287
  Email: bradley.joseph@advocatehealth.org
• Richard B Weinberg, MD — CONTACT
  Phone: 704-355-2000
  Email: Richard.Weinberg@advocatehealth.org

Study Officials

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

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