Effect of oral lactulose on clinical and immunohistochemical parameters in patients with inflammatory bowel disease: a prospective, randomised and controlled pilot study
| ISRCTN | ISRCTN92101486 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92101486 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/11/2006
- Registration date
- 13/12/2006
- Last edited
- 24/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Stephan C Bischoff
Scientific
Scientific
University of Hohenheim
Department of Nutritional Medicine
Fruwirthstrasse 12
Stuttgart
70599
Germany
Study information
| Study design | Prospective, randomised and controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Lactulose |
| Study objectives | Inflammatory bowel diseases (IBD), commonly referred to as Crohns Disease (CD) and Ulcerative Colitis (UC) are recurrent aggressive inflammatory conditions of multifactorial etiology, which to date are not well understood. Interactions of genetic background, disturbance of the mucosal barrier, dysregulation of intestinal immune responses as well as bacterial and other environmental factors were found to play a role in the development of IBD. Aims of trial: Positive clinical and histological efficacy of lactulose in patients with IBD. |
| Ethics approval(s) | The study was approved by the Ethical Committee of the Hannover Medical School, dated 7th February 2000 (ref: No 2229). All procedures were in accordance with the Declaration of Helsinki. |
| Health condition(s) or problem(s) studied | Inflammatory Bowel Disease (IBD), Crohns Disease (CD), Ulcerative Colitis (UC) |
| Intervention | The aim of the present study was to investigate clinical effects of the prebiotic "lactulose" in IBD patients. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oral lactulose |
| Primary outcome measure | Improvement of clinical activity |
| Secondary outcome measures | 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 |
| Overall study start date | 01/08/2000 |
| Completion date | 01/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 70 |
| Key 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 Crohns 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. |
| Key exclusion criteria | 1. Surgery during study period 2. Other diseases than IBD |
| Date of first enrolment | 01/08/2000 |
| Date of final enrolment | 01/07/2003 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Hohenheim
Stuttgart
70599
Germany
70599
Germany
Sponsor information
Solvay Pharmaceuticals GmbH (Germany)
Industry
Industry
Hans-Böckler-Allee 20
Hannover
30173
Germany
| Website | http://www.solvay.de/ |
|---|---|
"ROR" |
https://ror.org/01xscrc43 |
Funders
Funder type
Industry
Funding was supplied by Solvay Pharmaceuticals GmbH, which covered expenses for drugs and equipment (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/09/2007 | Yes | No |
