K90-K93
Conditions
Interventions
Group 1: Intervention group: patients perform a nutritional therapy tailored to their CLE result
Group 2: Control group: Patients follow a 5-time standard elimination diet and avoid milk, egg, wheat,
Sponsors
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - Positive mucosal reaction during previous CLE examination (according to CLE FAST criteria) in the course of a routine examination (not part of this study) - Duration of disease (gastrointestinal symptoms) > 6 months - age: 18 - 70 years - Unchanged medication in stable (unchanged) dose for at least 3 months - Documented exclusion of disease associated with adverse reactions to food. These include: * Proven carbohydrate malassimilation (via H2 breath test). * Wheat allergy * celiac disease * eosinophilic colitis * chronic inflammatory bowel disease - Sufficient knowledge of German to understand the study material - Possession of a smartphone
Exclusion criteria
Exclusion criteria: - Food allergy with known allergen - history of anaphylactic reaction due to a food product - inflammatory, structural or neoplastic gastrointestinal disease - Existing or performed 5-fold or 6-fold oligoantigenic elimination diet within the last 6 months - Regular use of antiallergic medications, antibiotics, or proton pump inhibitors (PPI) within the past 3 months - regular intake of probiotics or prebiotics within the last 3 months - Eating disorder such as anorexia or bulimia nervosa - harmful alcohol use within the last 3 months - Drug use in the past 3 months (other than smoking) - clinically relevant acute or chronic inflammatory disease (e.g., symptomatic coronary artery disease, chronic renal failure, COPD, etc.) - Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First co-primary endpoint: average change in health-related quality of life (HRQL) 12 weeks after the start of the intervention measured with the Food Allergy Quality of Life Questionnaire - Adult Form (FAQLQ-AF). Second co-primary endpoint: average symptom severity 12 weeks after the start of the intervention measured with the Irritable Bowel Syndrome- Symptoms Severity Score (IBS-SSS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: Changes in the following secondary endpoints compared with the start of the intervention (exact time points in parentheses): - Symptom severity by score on the IBS-SSS (weeks 4, 8, and 12). - HRQL by score on the FAQLQ-AF (weeks 4 and 8). - HRQL by score in the IBS Quality of Life (IBS-QOL). (Weeks 4, 8, and 12) - Self-assessed health status measured by EQ visual analogue scale (EQ-VAS) (weeks 4, 8 and 12). - Number of days with a pathologically altered stool type (type 1/2 or 6/7) per week in the Bristol Stool Form Scale (week 4, 8,and 12) | — |
Countries
Germany
Contacts
Public ContactGreta Ahlemann
University Hospital Schleswig-Holstein, Institute of nutritional medicine
Outcome results
None listed