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The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In a head-to-head comparison survey, mBIOTA outperformed its leading market competitor in six palatability domains (taste, smell, consistency, aftertaste, appearance, and impression)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The EDICT trial studies a diet treatment for flare-ups of inflammatory bowel disease (IBD), which causes long-term swelling in the digestive tract. It is for adults with Crohn's disease or ulcerative colitis whose flare-ups are treated without a hospital stay.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are an adult with a confirmed diagnosis of Crohn's disease or ulcerative colitis.
  • You are being treated outside the hospital for a flare-up with a major increase in symptoms, such as belly pain, nausea, vomiting, diarrhea, joint pain, fever, bleeding, or weight loss without trying.

Who can't join

  • You need a hospital stay to treat your flare-up.
  • You are allergic to any ingredient in the mBIOTA Elemental Diet, the study diet.
  • You are pregnant.
  • You have diabetes and take insulin.
  • You have another health condition or personal preference that would keep you from following the study diet.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC