Inflammatory Bowel Disease
Conditions
Keywords
crohn's disease, ulcerative colitis, chronic gastrointestinal tract inflammation
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTelemental diet (ED)
mBIOTA is a palatable elemental diet formulation
Sponsors
Wake Forest University Health Sciences
mBIOTA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of symptom burden scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in inflammatory markers - Erythrocyte Sedimentation Rate (ESR) | Baseline, Weeks 2 and 4 | 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) | Baseline, Weeks 2 and 4 | 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 | Baseline, Weeks 2 and 4 | 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 | Baseline, Weeks 2 and 4 | 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. |
| changes in nutritional status - Bioelectrical Impedance Analysis score | Baseline, Weeks 2 and 4 | 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. |
| number of prednisone equivalents | Week 12 | total amount of supplemental steroids given as treatment of inflammatory bowel disease, measured as prednisone equivalents |
| number of Emergency Department visits or hospitalization visits | Week 1 to Week 12 | number of Emergency Department visits or hospitalization visits |
Countries
United States
Contacts
CONTACTBradley Joseph, MD
CONTACTRichard B Weinberg, MD
PRINCIPAL_INVESTIGATORRichard B Weinberg, MD
Wake Forest University Health Sciences
Outcome results
None listed