Inflammatory Bowel Disease (IBD), Crohn?s Disease (CD), Ulcerative Colitis (UC) Digestive System Noninfective enteritis and colitis
Conditions
Interventions
The aim of the present study was to investigate clinical effects of the prebiotic "lactulose" in IBD patients.
Sponsors
Solvay Pharmaceuticals GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be included in the trial, patients had to present IBD. The majority of patients enrolled in this study were hospitalised because of symptoms of active disease and in most of them the clinical activity was confirmed by elevated Clinical Activity Index (CAI) scores in UC or elevated Crohn?s Disease Activity Index (CDAI) scores. The diagnosis of IBD was confirmed by classical clinical and endoscopic means according to the German and Austrian guidelines for UC and CD.
Exclusion criteria
Exclusion criteria: 1. Surgery during study period 2. Other diseases than IBD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of clinical activity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life 2. Medication 3. Endoscopic score 4. Laboratory parameters: a. Haemoglobin (Hb) values b. Haematocrit values c. Orsomucoid (Ors) d. Albumin (Alb) e. Immunoglobulins G, A and M (IgG, IgA and IgM respectively) f. Alpha-1-antitrypsin g. pH in faeces | — |
Countries
Germany
Outcome results
None listed