Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Lactulose
Study hypothesis
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
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.
Study design
Prospective, randomised and controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/08/2000
Overall trial end date
01/07/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
70
Participant exclusion criteria
1. Surgery during study period
2. Other diseases than IBD
Recruitment start date
01/08/2000
Recruitment end date
01/07/2003
Locations
Countries of recruitment
Germany
Trial participating centre
University of Hohenheim
Stuttgart
70599
Germany
Sponsor information
Organisation
Solvay Pharmaceuticals GmbH (Germany)
Sponsor details
Hans-Böckler-Allee 20
Hannover
30173
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Funding was supplied by Solvay Pharmaceuticals GmbH, which covered expenses for drugs and equipment (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17784949
Publication citations
-
Results
Hafer A, Krämer S, Duncker S, Krüger M, Manns MP, Bischoff SC, Effect of oral lactulose on clinical and immunohistochemical parameters in patients with inflammatory bowel disease: a pilot study., BMC Gastroenterol, 2007, 7, 36, doi: 10.1186/1471-230X-7-36.