A pilot study to investigate the use of recombinant cholera toxin B subunit in the treatment of active Crohn’s disease.

• Conditions: Inflammatory Bowel Disease (IBD) is the comprehensive term for disorders involving chronic inflammation in the gastrointestinal tract, often the small intestine and colon. It is believed to be a disorder mediated by T lymphocytes that arise in genetically susceptible persons as a result of a breakdown in the regulatory constraints on mucosal immune responses to enteric bacteria. Evidence suggests that Th1 T cells play an important pathogenetic role in Crohn´s disease.; Level: PTClassification code 10011401

• Registration Number: EUCTR2005-002048-25-SE
• Lead Sponsor: SBL Vaccin AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

•Male or female aged 18 to 70 years.
•A previously established diagnosis of Crohn´s disease verified with
enteroclysis/small bowel follow-through, barium enema, endoscopy or
histology. Should be performed within 24 months prior to study initiation.
•Active disease of mild to moderate degree. CDAI (Crohn´s Disease Activity
Index) score = 220 and = 400.
•If ongoing treatment with sulphasalazine (SASP) or 5-ASA, corticostereoids
or immunomodulators, the dose regimen must have been unchanged for
at least 4 weeks and must have been initiated at least 12 weeks prior to
inclusion.
•CRP>5.
•Give written informed consent to participate.
•Willing and able to communicate with the Investigator and understand the
requirements of the study.
•Females should unless being menopausal agree to use reliable
contraception (hormonal contraceptives or intra-uterine device), at least
from 1 month prior to inclusion until three months after last intake of study
drug.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Treatment with metronidazole within the last four weeks.
•Treatment with any biological drug, including infliximab, within 12 weeks.
•Has received Dukoral in the last year.
•Patient with a known intestinal stricture or symptoms or history indicating
a stenotic condition.
•Active fistulating disease.
•Any condition which would limit the patient’s ability to complete the study
in the opinion of the Investigator.
•History of drug or chemical abuse in the year before the study.
•Receipt of any other investigational product in the month before study
entry.
•Concomitant participation in any other clinical study.
•Donation of blood 6 weeks before study entry or at any time during the
study.
•Females who are pregnant or lactating.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the clinical response of rCTB given in a dose of 5 mg three times a week for two weeks to treat active Crohn`s disease (CD).;Secondary Objective: To evaluate safety and tolerability of rCTB given in a dose of 5 mg three times a week for two weeks. ;Primary end point(s): Frequency of patients with a reduction in CDAI score of 100 points or more between pre-dose and 2 weeks after last dose (at day 29).