The purpose of this study is to investigate if the probiotic Bifidobacterium breve Bif195 (Bif195) will result in improvement in clinical outcome in patients with small intestinal Crohn's disease.
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) with an incidence rate at 11/100 000 per year in Denmark. The disease can potentially affect the entire gastrointestinal tract, though the most common affected area is terminal ileum and the adjacent part of colon. CD is a result of both genetic and environmental factors together with the intestinal microbiota, however the precise etiology is unclear. A change of the intestinal microbiota with a reduced occurrence of e.g. Bacteroides species, Firmicutes and the anti-inflammatory bacteria Faecalibacterium prausnitzii is found in CD patients compared to healthy controls. Also a reduction of the mucosa-associated Bifidobacteria has been associated with the risk of mucosal inflammation. The hypothesis that an imbalance between potentially beneficial and pathogenic bacteria contribute to the pathogenesis of IBD, including CD, has led to the suggestion that manipulation of the microbiota may be an attractive target for therapeutic interventions in IBD. A new probiotic bacterium, Bifidobacterium breve Bif195 (Bif195) has been identified and has shown great effects on preventing enteropathy and ulcers on the gut mucosa in healthy volunteers given acetylsalicylic acid (13), and thereby Bif195 has also shown a potential in reducing gut permeability defects. This bacterium has not yet been investigated in CD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
1 capsule daily for 8 weeks
1 capsule daily for 8 weeks
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Copenhagen, Denmark
Change in Bowel Wall Thickness (BWT) from baseline measured by intestinal ultrasound (IUS) at 8 weeks
IUS will be performed in the non-fasting patient lying in supine position with a high-end ultrasound machine (Siemens Sequoia) with 10L4 transducer.
Time frame: 8 weeks
Change in fecal calprotectin level from baseline at 8 weeks
measured from a fecal sample
Time frame: 8 weeks
Change in severity of symptoms from baseline measured by Harvey-Bradshaw index (HBI) at 8 weeks
HBI is a disease activity index for Crohns disease and consists of clinical parameters
Time frame: 8 weeks
Change in quality of life from baseline measured by Inflammatory Bowel Disease Questionnaire (IBDQ) Questionnaire Scores at 8 weeks
The IBDQ is a widely used instrument to assess QoL among IBD patients and consists of 32 questionaire
Time frame: 8 weeks
The change from baseline on Color Doppler Imaging Score (0-3) including inflammatory fat and ulceration (yes/no) at 8 weeks
measured by intestinal ultrasound (IUS)
Time frame: 8 weeks
Adverse and severe adverse events
Registered, if any events. Reported according to IHC-GCP
Time frame: 16 weeks
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