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Clinical trial: the safety and short-term efficacy of recombinant cholera toxin B subunit in the treatment of active Crohn's disease
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
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2010 (English)In: Alimentary Pharmacology and Therapeutics, ISSN 0269-2813, E-ISSN 1365-2036, Vol. 31, no 3, 387-395 p.Article in journal (Refereed) Published
Abstract [en]

Background The cholera toxin B subunit ameliorates experimentally induced colitis in mice. In humans, cholera toxin B subunit has never been tested in the treatment of Crohn's disease (CD). Aim To evaluate the safety and efficacy of treatment with recombinant cholera toxin B subunit of patients with CD. Methods An open-label, multicentre, nonrandomized trial including 15 patients with mild/moderate CD. Patients received an oral solution of 5 mg recombinant cholera toxin B subunit three times weekly for 2 weeks. Reduction in CD Activity Index (CDAI) with > 100 between baseline and days 15, 29, 42 and 70 defined clinical response. Patients with CDAI score < 150 were defined as being in remission. Results A significant decrease in CDAI score was observed. Response rates were 40% in the full analysis set and 42% in the per protocol analysis. Two patients receiving adjuvant treatment after day 29 were excluded, after which 40% were in remission at 4 weeks and 30% at 8 weeks post-treatment. Mild side effects (arthralgia, headache and pruritus) were seen in 33% of patients. Conclusions Treatment with recombinant cholera toxin B subunit was safe. Approximately 40% of patients with active CD responded to treatment. Randomized studies are needed to establish the clinical efficacy of recombinant cholera toxin B subunit.

Place, publisher, year, edition, pages
2010. Vol. 31, no 3, 387-395 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-137981DOI: 10.1111/j.1365-2036.2009.04185.xISI: 000273300700005OAI: oai:DiVA.org:uu-137981DiVA: diva2:378924
Available from: 2010-12-16 Created: 2010-12-16 Last updated: 2010-12-16Bibliographically approved

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