Elemental Diet for Inflammatory Bowel Disease

(EDICT Trial)

Overseen By Richard B Weinberg, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Hospitalization, Allergies, Pregnancy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an elemental diet (a specialized nutrition plan) as a new method to manage inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. Researchers aim to determine if this diet can reduce symptoms like stomach pain, diarrhea, and joint pain without the side effects of current medications. The trial includes two groups: one will follow the elemental diet, while the other will receive regular dietary advice. It suits adults with IBD experiencing symptom flares, such as frequent abdominal pain and diarrhea, but not requiring hospital care. As an unphased trial, this study provides a unique opportunity to explore a potentially groundbreaking dietary approach to managing IBD symptoms.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the elemental diet is safe for treating inflammatory bowel disease?

Research has shown that elemental diets can be a safe choice for people with inflammatory bowel disease (IBD). In studies, patients reported fewer symptoms such as stomach pain, bloating, and gas while following these diets. They also experienced less constipation, indicating the diet's ease of use. One study found that patients on an elemental diet had shorter hospital stays and improved health indicators, such as higher protein levels in their blood, after just one week. These findings suggest that elemental diets may effectively manage IBD symptoms. However, individual experiences may vary, and discussing options with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard medications and therapies for inflammatory bowel disease (IBD), which often involve anti-inflammatory drugs or immunosuppressants, the elemental diet offers a unique nutritional approach. Researchers are excited about this treatment because it simplifies digestion by providing nutrients in their simplest forms, potentially reducing inflammation and allowing the gut to heal. Moreover, this diet might offer quicker symptom relief since it minimizes digestive workload, which is especially beneficial for individuals struggling with severe digestive issues.

What evidence suggests that an elemental diet might be an effective treatment for inflammatory bowel disease?

Research has shown that elemental diets, which are special liquid diets made from easily digestible nutrients, can help manage inflammatory bowel disease (IBD). One study found that these diets significantly improved symptoms in people with Crohn's disease, with many reaching remission. Another study discovered that patients on an elemental diet spent less time in the hospital and had better nutrition, indicated by higher levels of the key protein albumin. Elemental diets have proven to be as effective as some traditional treatments, like steroids, but with fewer side effects. In this trial, participants in the elemental diet arm will receive a specific formulation produced by mBIOTA. Overall, elemental diets offer a promising option for managing IBD symptoms. ^{4 5 6 7 8}

Who Is on the Research Team?

Richard B Weinberg, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

The EDICT Trial is for individuals with Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis, who frequently experience symptomatic flares. Participants should be seeking alternative treatments to corticosteroids or other common medications due to concerns about long-term side effects.

Inclusion Criteria

I have IBD and am currently experiencing a flare-up with symptoms like pain or diarrhea.

Exclusion Criteria

I am currently pregnant.

I have diabetes and am taking insulin.

Patients with allergies to any ingredients in the mBIOTA Elemental Diet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a two-week supply of mBIOTA elemental diet or dietary counseling

2 weeks

1 visit (in-person) for baseline assessment

Follow-up

Participants are monitored for changes in symptom burden and inflammatory markers

10 weeks

3 visits (in-person) at Weeks 2, 4, and 12

Long-term follow-up

Participants are monitored for long-term safety and effectiveness

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Elemental Diet

Trial Overview This trial is testing an elemental diet (ED) as a treatment option during IBD flares. The study aims to provide evidence on whether this dietary intervention can reduce symptoms without the harmful side effects associated with traditional medications.

How Is the Trial Designed?

Group I: elemental diet (ED) Experimental Treatment 1 Intervention

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.

Group II: control group Active Control 1 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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

mBIOTA

Collaborator

Citations

1. cghjournal.org cghjournal.org/article/S1542-3565(19)31394-1/fulltext

Diet in Treatment of Inflammatory Bowel Diseases Although achievement of clinical remission was comparable between both groups (67% and 79%, respectively), EEN was more effective in achieving ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03983837?cond=(GLUCOCORTICOID%20DEFICIENCY)%20OR%20(MC2R)&rank=4

Elemental Diet for Treatment of Inflammatory Bowel ... In this study, we propose to treat 5 patients >= 8 years old who have CGD and IBD with 4 weeks of an elemental diet.

3. academic.oup.com academic.oup.com/crohnscolitis360/article/6/1/otad077/7465200

Diet and Nutrition in Inflammatory Bowel Disease: A Review of ... Thirty-two patients randomized to EEN for 7 days were found to have a shorter hospital stay and higher day 7 albumin level compared to 40 ...

4. link.springer.com link.springer.com/article/10.1007/s10620-024-08543-1

Elemental Diet as a Therapeutic Modality Elemental diets offer a potentially highly efficacious dietary intervention with minor side effects. Palatability, cost, access, and social restrictions are ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4734995/

Diet therapy for inflammatory bowel diseases - PubMed Central In 1984, O'Moráin et al[20] reported that patients with acute Crohn's ileitis treatment with an elemental diet achieved remission rates comparable to those ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9664119/

Diet fuelling inflammatory bowel diseases - PubMed Central In turn, dietary restriction with an elemental diet (which may reduce an excess of Western dietary constituents) induces remission in paediatric ...

7. cghjournal.org cghjournal.org/article/S1542-3565(25)00241-1/fulltext

Effect, Tolerability, and Safety of Exclusive Palatable ... Subjects reported significant reductions in abdominal discomfort, bloating, distention, flatulence, and constipation during PED, with further ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1542356525002411

Effect, Tolerability, and Safety of Exclusive Palatable ... We aimed to assess the effect, tolerance, and safety of a novel palatable ED (PED) in subjects with IMO and/or SIBO.