The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares

Wake Forest University (WFU)

Status: Not yet enrolling

Conditions: Inflammatory Bowel Disease

Treatments: Dietary Supplement: elemental diet (ED)

Study type: Interventional

Funder types: Other

Identifiers

NCT07143188

IRB00126650

Details and patient eligibility

About

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.

Full 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 limited adherence to study diets due to poor palatability. Therefore, although exclusive EN may have a role in IBD treatment, there is limited data to support its use.

Elemental diets (ED) are a form of enteral nutrition in which free amino acids, mono- and polysaccharides, short or medium chain triglycerides, vitamins, and minerals are combined to provide a complete nutritional source. EDs have a long history of use in treating inflammatory diseases of the GI tract, such as IBD, eosinophilic esophagitis, and small intestinal bacterial overgrowth. The hypothesized benefit of EDs stems from their highly efficient absorption that requires minimal digestion, as well as the absence of allergenic antigens. As with other EN studies, examining the use of EDs for treatment of inflammatory gastrointestinal diseases have been limited by very poor palatability.

mBIOTA is a palatable elemental diet formulation that may be a more acceptable treatment option for a variety of GI problems. In a head-to-head comparison survey, mBIOTA outperformed its leading market competitor in six palatability domains (taste, smell, consistency, aftertaste, appearance, and impression). In a recently published study investigating ED for treatment of small intestinal bacterial overgrowth, subjects had a 100% adherence rate to mBIOTA supplementation during the trial period. Given its improved palatability compared to its predecessors, mBIOTA could prove useful as a new therapeutic tool in the treatment of inflammatory bowel disease.

Enrollment: 42 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

elemental diet (ED)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: elemental diet (ED)

control group

No Intervention group

Description:

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.