Condition category
Digestive System
Date applied
16/11/2006
Date assigned
13/12/2006
Last edited
24/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephan C Bischoff

ORCID ID

Contact details

University of Hohenheim
Department of Nutritional Medicine
Fruwirthstrasse 12
Stuttgart
70599
Germany

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 Crohn’s 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), Crohn’s 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 measures

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

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 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.

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

http://www.solvay.de/

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17784949

Publication citations

  1. 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.

Additional files

Editorial Notes