The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares

NCT07143188 | Not Yet Recruiting

• 1 other identifier: IRB00126650
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Inflammatory Bowel Disease

Keywords

crohn's disease; ulcerative colitis; chronic gastrointestinal tract inflammation

Outcome Measures

Primary Outcomes (1)

• change of symptom burden scores

  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.

  Week 1 to Week 12

Secondary Outcomes (7)

• 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

Study Arms (2)

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.

Dietary Supplement: elemental diet (ED)

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

elemental diet (ED) DIETARY_SUPPLEMENT

mBIOTA is a palatable elemental diet formulation

Also known as: mBIOTA elemental diet

elemental diet (ED)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• mBIOTA: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Richard B Weinberg, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bradley Joseph, MD

CONTACT

703-463-1287; bradley.joseph@advocatehealth.org

Richard B Weinberg, MD

CONTACT

704-355-2000; Richard.Weinberg@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, open-label, parallel group controlled trial - Patients with an established diagnosis of Inflammatory bowel disease (Crohn's disease (CD) or ulcerative colitis (UC)) who are having a flare will be assessed for eligibility criteria; eligible patients will be randomized to one of two groups, both of which will receive standard of care pharmacologic treatment: 1) a control group which will receive standard dietary advice; 2) a treatment group in which all nutrition will be provided by mBIOTA elemental diet for 2 weeks.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 27, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)