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.

Week 1 to Week 12

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.

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.

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.

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.

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.

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

Week 12

number of Emergency Department visits or hospitalization visits

number of Emergency Department visits or hospitalization visits

Week 1 to Week 12