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.
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).
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
Parallel
elemental diet (ED)
Dietary supplementmBIOTA is a palatable elemental diet formulation
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.
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.
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.
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.
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.
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Wake Forest University Health Sciences
Lead sponsor
mBIOTA
Collaborator
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