Crohn's disease, colitis ulcerosa K51
Conditions
Interventions
Group 1: Patients with IBD in remission
No investigational medicinal products promoted.
Following sugar volumes will be given in the course of a routine clinical examination with regard to the diagn
Sponsors
CED Service GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for active IBD patients: 1. Colitis ulcerosa or Crohn’s disease of the colon 2. Crohn’s disease: Harvey-Bradshaw Index = 7 3. Colitis ulcerosa: Powell-Tuck Index > 4 4. No small bowel and colon resection 5. Age between 18- 80 years Inclusion criteria for IBD patients in remission: 1. Colitis ulcerosa or Crohn’s disease of the colon 2. Crohn’s disease: Harvey-Bradshaw Index < 4 3. Colitis ulcerosa: Powell-Tuck Index = 4 4. No small bowel and colon resection 5. Age between 18- 80 years Inclusion criteria for control group patients: 1. No known abdominal symptoms 2. No postprandial symptoms 3. Age between 18- 80 years
Exclusion criteria
Exclusion criteria: 1. Antibiotics therapy up to 4 weeks before the examination 2. Inability to full fill the criteria of the study protocol 3. Condition after a small bowel and colon resection 4. Operation within last 3 months (gastro-intestinal tract) 5. Unstable thyroid diseases (no constant medication within last year) 6. Known Diabetes mellitus 7. Chronic liver diseases (transaminases > twice of normal value); last blood test results should be not older than 6 weeks 8. Renal dysfunction (serumkreatinin > 1,2 mg/dl); last blood test results should be not older than 6 weeks 9. Intake of medication, which influence absorption, metabolism and excretion of food components or gastro-intestinal motility (e.g. metoclopramide, diuretics, laxatives etc.) 10. Legal incapacity or limited legal incapacity 11. Other exclusion criteria at the investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The target of the study is to analyse the influence of a fructose malabsorption by using generally applicable diagnostics of H2 malabsorption testing to ulcerative colitis and Crohn’s disease. The application of the fructose malabsorption testing by IBD should explore the primary factors of fructose malabsorption, potential complaints, exclusion factors for a secondary fructose malabsorption as well as desertion of H2 non-producers. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Is the patient rate with a fructose malabsoprtion higher by the IBD patients (with affected colon) or by the control group patients, e.g. by patients with irritable bowel syndrome (symptoms without inflammation)? 2. Is the pain perception higher by IBD patiens with fructose malabsorption in comparance to the control group patiens e.g. patients with irritable bowel syndrome? 3. Does fructose malabsorption appears inscreased exclusive by IBD patients with affected colon during the inflammable phase? Additionally, the data about the patient's condition during each H2 testing, especially the behaviour of flatulences, abdominal pain and of diarrhoea, is collected and documented in the CRF in short terms intervals e.g. every 15 minutes. | — |
Countries
Germany
Contacts
Public ContactUlf Helwig
Gemeinschaftspraxis
Outcome results
None listed