Inflammatory Bowel DiseaseEDICTNCT07143188
The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares
A study testing elemental diet (ED) in people with Inflammatory Bowel Disease, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- elemental diet (ED)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Bradley Joseph, MD, 703-463-1287, bradley.joseph@advocatehealth.org
Richard B Weinberg, MD, 704-355-2000, Richard.Weinberg@advocatehealth.org
About this study
Official title: Elemental Diet as an Adjunctive Therapy for Inflammatory Bowel Disease Flares The EDICT Trial
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.
Read the detailed 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.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- elemental diet (ED)
- Keywords
- crohn's disease, ulcerative colitis, chronic gastrointestinal tract inflammation
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elemental diet (ED)Dietary supplement
Also called mBIOTA elemental diet
mBIOTA is a palatable elemental diet formulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1 to Week 12
Secondary outcomes (7)
changes in inflammatory markers - Erythrocyte Sedimentation Rate (ESR)
a blood test that measures the rate at which red blood cells settle at the bottom of a test tube. This rate is an indicator of inflammation in the body, with a faster settling rate suggesting higher inflammation. It's a general marker, meaning it can be elevated in various conditions, but it's not specific to any single disease - High ESR: Suggests inflammation, which could be due to infections, autoimmune diseases, or some types of cancer.
Normal ESR: Doesn't always rule out inflammation, as some inflammatory conditions may not cause a significant ESR elevation.
Measured: Baseline, Weeks 2 and 4
changes in inflammatory markers - C-reactive protein (CRP)
a blood test that measures inflammation in the body. It's an acute-phase reactant, meaning its levels rise in response to inflammation or infection. Elevated CRP can indicate various conditions, including infections, autoimmune diseases, and even heart disease risk.
Normal:
Generally, a level below 1.0 mg/dL is considered normal, according to the National Institutes of Health (NIH).
Mildly elevated:
Levels between 1.0 and 10.0 mg/dL may indicate conditions like obesity, pregnancy, or minor infections.
Moderately elevated:
Levels between 10.0 and 100.0 mg/dL can be associated with autoimmune diseases, pancreatitis, or bronchitis.
Markedly elevated:
Levels above 100.0 mg/dL often suggest acute bacterial infection, major trauma, or severe inflammation.
Measured: Baseline, Weeks 2 and 4
changes in inflammatory markers - fecal calprotectin
a valuable inflammatory marker, particularly for assessing gastrointestinal inflammation, and is often used in the diagnosis and management of inflammatory bowel disease (IBD). It is a protein released by neutrophils (white blood cells) that are recruited to sites of inflammation in the gut. Elevated levels of fecal calprotectin suggest active inflammation in the intestines.
Measured: Baseline, Weeks 2 and 4
changes in nutritional status - Prealbumin
Prealbumin is a measure of nutritional status, with a low level meaning undernutrition. The normal range is 15-36 Low levels (<15 mg/dL) may indicate malnutrition, protein deficiency, inflammation, or liver disease.
High levels (>36 mg/dL) may be seen in certain medications (e.g., corticosteroids), kidney failure, or multiple myeloma.
Measured: Baseline, Weeks 2 and 4
changes in nutritional status - Bioelectrical Impedance Analysis score
Bioelectrical Impedance Analysis score (BIA) will be used to estimate lean muscle mass (body cell mass) and fat mass. Ideal body cell mass in men is estimated as 40-45% of ideal body weight for height. For women, the ideal body cell mass is estimated at 30-35% of ideal body weight for height. Ideal fat mass for men is around 10-20% of actual body weight. Ideal fat mass for women is estimated at 20-30% of actual body weight.
Measured: Baseline, Weeks 2 and 4
number of prednisone equivalents
total amount of supplemental steroids given as treatment of inflammatory bowel disease, measured as prednisone equivalents
Measured: Week 12
number of Emergency Department visits or hospitalization visits
number of Emergency Department visits or hospitalization visits
Measured: Week 1 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study startDec 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- mBIOTA
- Responsible party
- Sponsor
- Investigators
- Richard B Weinberg, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143188
- Sponsor's protocol ID
- IRB00126650
- Acronym
- EDICT
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elemental Diet as an Adjunctive Therapy for Inflammatory Bowel Disease Flares The EDICT Trial
- ClinicalTrials.gov ID
- NCT07143188
- Acronym / sponsor ID
- EDICT / IRB00126650
- Conditions
- Inflammatory Bowel Disease
- Keywords
- crohn's disease, ulcerative colitis, chronic gastrointestinal tract inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- mBIOTA
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| elemental diet (ED) | Experimental | Dietary Supplement: elemental diet (ED)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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elemental diet (ED)Also: mBIOTA elemental dietmBIOTA is a palatable elemental diet formulation | Dietary supplement | elemental diet (ED) |
Primary outcome
change of symptom burden scores
Time frame: Week 1 to Week 12
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.
7 secondary outcomes
changes in inflammatory markers - Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline, Weeks 2 and 4
changes in inflammatory markers - C-reactive protein (CRP)
Time frame: Baseline, Weeks 2 and 4
changes in inflammatory markers - fecal calprotectin
Time frame: Baseline, Weeks 2 and 4
changes in nutritional status - Prealbumin
Time frame: Baseline, Weeks 2 and 4
changes in nutritional status - Bioelectrical Impedance Analysis score
Time frame: Baseline, Weeks 2 and 4
number of prednisone equivalents
Time frame: Week 12
number of Emergency Department visits or hospitalization visits
Time frame: Week 1 to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Disease
Not yet recruitingObservational study
Longitudinal Registry of Difficult-to-Treat Inflammatory Bowel Disease
Inflammatory Bowel Diseases (IBD), Crohn Disease
Recruiting
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC)
RecruitingPhase 4
Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD
Crohn Disease
Not yet recruiting
Online Pain Education for Crohn's Disease and Ulcerative Colitis
Crohn's Disease, Ulcerative Colitis (UC)
RecruitingObservational study
Immune Regulation in Ulcerative Colitis or Crohn s Disease
Inflammatory Bowel Disease, Ulcerative Colitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard B Weinberg, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing elemental diet (ED) in people with Inflammatory Bowel Disease, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bradley Joseph, MD (703-463-1287, bradley.joseph@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of symptom burden scores (time frame: Week 1 to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.