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Short Form Health Survey - 12 Items (SF-12)
Time frame: Baseline, up to 14 days, 6 months, 12 months
0-100, higher scores indicate better health status.
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EuroQol 5-Dimension 5-Level
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0 (worst) to 1 (best), higher scores indicate better health-related quality of life.
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Food Frequency List
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Descriptive measure; not scored on a numeric scale.
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International Physical Activity Questionnaire - Short Form
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
MET-min/week (variable), higher scores indicate higher physical activity levels.
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Hospital Anxiety and Depression Scale
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-21 per subscale (Anxiety and Depression), higher scores indicate more severe symptoms.
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Work Productivity and Activity Impairment Questionnaire
Time frame: Baseline, 3 months, 6 months, 12 months
0%-100%, higher scores indicate greater impairment (i.e., worse outcome).
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Perceived Stress Scale - 4
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-16, higher scores indicate higher perceived stress.
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Main complaint
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Visual Analog Scale (0-100, higher scores mean a worse outcome)
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Fibromyalgia Impact Questionnaire
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-100, higher scores indicate greater impact of fibromyalgia (worse outcome).
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Rheumatoid Arthritis Disease Activity Index
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-10, higher scores indicate greater disease activity (worse outcome).
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Bath Ankylosing Spondylitis Disease Activity Index
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-10, higher scores indicate more active disease (worse outcome).
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Bath Ankylosing Spondylitis Functional Index
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-10, higher scores indicate more functional limitation (worse outcome).
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Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-100, higher scores indicate greater pain/stiffness/disability (worse outcome).
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Irritable Bowel Syndrome Symptom Severity Score
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-500, higher scores indicate more severe IBS symptoms (worse outcome).
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Short Inflammatory Bowel Disease Questionnaire
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
10-70, higher scores indicate better quality of life.
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Pain Disability Index
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-70, higher scores indicate greater disability (worse outcome).
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Roland Morris Disability Questionnaire
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-24, higher scores indicate more severe disability (worse outcome).
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Maslach Burnout Inventory
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Variable by subscale (Emotional Exhaustion: 0-54, Depersonalization: 0-30, Personal Accomplishment: 0-48) Higher scores on EE/DP = worse outcome; higher PA = better outcome.
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Beck Depression Inventory-II
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-63, higher scores indicate more severe depressive symptoms (worse outcome).
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Diabetes Distress Scale - 2
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
1-6, higher scores indicate greater emotional distress related to diabetes (worse outcome).
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Dermatology Life Quality Index
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-30, higher scores indicate greater impact on quality of life (worse outcome).
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Functional Assessment of Cancer Therapy - General
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-108, higher scores indicate better quality of life.
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Use of the healthcare system
Time frame: Baseline,12 months
Descriptive data (e.g., number of visits); not a scored scale.
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Expectations regarding inpatient TCIM treatment
Time frame: Baseline
5-point Likert scale, 1-5. Higher scores indicate stronger or more positive expectations.
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Chalder Fatigue Scale
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-33, higher scores mean a worse outcome
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Somatic Symptom Scale
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
0-32, higher scores mean a worse outcome
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Body weight [kg]
Time frame: Baseline, up to 14 days
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Height [in cm]
Time frame: Baseline
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BMI [kg/m2]
Time frame: Baseline, up to 14 days
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Systolic blood pressure [mmHg], diastolic blood pressure [mmHg]
Time frame: Baseline, up to 14 days
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Waist circumference [in cm]
Time frame: Baseline, up to 14 days
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Triglycerides [mg/dl]
Time frame: Baseline, up to 14 days
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Total cholesterol [mg/dl]
Time frame: Baseline, up to 14 days
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HDL [mg/dl]
Time frame: Baseline, up to 14 days
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LDL [mg/dl]
Time frame: Baseline, up to 14 days
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Glucose [mg/dl]
Time frame: Baseline, up to 14 days
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Uric acid [μmol/L]
Time frame: Baseline, up to 14 days
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Creatinine [mg/dl]
Time frame: Baseline, up to 14 days
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CRP [mg/l]
Time frame: Baseline, up to 14 days
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GPT [U/l]
Time frame: Baseline, up to 14 days
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HbA1c [mmol/mol]
Time frame: Baseline, up to 14 days
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HbA1c [%]
Time frame: Baseline, up to 14 days
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Headache Impact Test (HIT-6)
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
36-78. A higher value indicates a greater impairment due to headaches.
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Integrity of the duodenal intestinal barrier analyzed by confocal laser endomicroscopy (CLE)
Time frame: Baseline, within 3 to 12 months
The integrity of the intestinal barrier is tested via CLE during routine esophagogastro-duodenoscopy to detect primary or secondary (food-induced) barrier defects.
By CLE, the intestinal mucosa and the epithelial lining can be analyzed in vivo with a 1000 x magnification. An intestinal barrier defect can be detected by the leakage of a contrast agent (fluorescein) from the blood vessels through the intestinal epithelial spaces into the intestinal cavity and the shedding of epithelial cells.
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Result of the esophagogastro-duodenoscopy
Time frame: Baseline, within 3 to 12 months
Participants undergo an esophagogastro- duodenoscopy with CLE when clinically indicated as part of their inpatient care. Thereby, the inflammatory status and the intestinal barrier is routinely analyzed.
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Histopathological analysis of duodenal biopsies
Time frame: Baseline, within 3 to 12 months
Intestinal biopsies, which are routinely taken during esophagogastroduodenoscopy, are processed for histopathological analysis of the mucosal and epithelial structure as well as of the immune cell compartment and to rule out inflammatory processes or intestinal infections.
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Immunohistochemical analysis of duodenal biopsies
Time frame: Baseline, within 3 to 12 months
Intestinal biopsies, which are routinely taken during esophagogastroduodenoscopy, are stained using immunohistochemistry and examined for the expression of specific marker proteins (e.g. CD3, eosinophils, Occludin, Claudins).
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IgE antibody titers
Time frame: Baseline, within 3 to 12 months
IgE screening of antibodies against typical food allergens (egg white, soy, milk, yeast, wheat) in the serum
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Analysis of fecal biomarkers, digestive parameters, intestinal flora
Time frame: Baseline, within 3 to 12 months
The concentrations of different fecal biomarkers are analyzed in stool samples:
Calprotectin, Lactoferrin, PMN-Elastase, EDN, Zonulin, Alpha-1-Antitrypsin, Beta-Defensin.
Furthermore, digestive parameters such as digestion residues and the intestinal flora are determined.
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Result of hydrogen breath tests
Time frame: Baseline, within 3 to 12 months
Lactose, fructose, and sorbitol intolerance is tested via hydrogen breath test