The Effect of Riboflavin in Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      This study will evaluate if suppelementation of the diet with riboflavin in Crohn's disease
      patients will result in an increase in the amount of F. prausnitzii.
    

Detailed description: 
      Rationale Recent studies show that in patients with Inflammatory Bowel Disease (IBD) a
      dysbiosis exists in the composition of the intestinal microbiota. In particular, the
      potentially pathogenic bacterium Escherichia coli (E. coli) is often more abundant in the
      bowel of IBD patients, and the anaerobic commensal Faecalibacterium prausnitzii (F.
      prausnitzii) is often reduced. This last mentioned bacteria is known to be abundant in the
      intestine of healthy individuals. It is known to produce butyrate, which stimulates the
      intestinal epithelium, and to secrete anti-inflammatory substances.

      Riboflavin - also known as vitamin B2 - is required for a wide variety of cellular processes
      and has an important role in maintaining health in humans. In a pilot intervention with
      healthy volunteers it is shown that a riboflavin supplement increases the number of F.
      prausnitzii and results in a higher production of butyrate. In Crohn's disease patients, it
      is known that the amount of F. prausnitzii in the intestine is generally low. Furthermore, it
      is known that there is an association between the number of F. prausnitzii bacteria and the
      length of disease in remission.

      This study will evaluate if supplementation of the diet with riboflavin in Crohn's disease
      patients will result in a similar increase in the amount of F. prausnitzii as in healthy
      volunteers. In this patient group, an increase in the number of F. prausnitzii bacteria in
      the bowel may result in a more favourable disease course. This will be assessed with faeces
      calprotectin and two questionnaires. Additionally the investigators will assess if there is
      any modulation by riboflavin on the other intestinal bacteria, short chain fatty acids
      (SCFAs) (such as butyrate), and the pH of the faeces. Finally, the effect of the riboflavin
      on the permeability of the gut will be evaluated with a Chroom-EDTA test, and a number of
      different biomarkers of permeability.

      Hypothesis The hypothesis is that in Crohn's disease patients, supplementation of the diet
      with riboflavin results in an increase in the amount of F. prausnitzii, changes in microbial
      composition, increased fatty acid production, an increase in pH and a reduction of intestinal
      permeability. These changes might result in a more favourable disease course with less
      exacerbations.

      Study design Prospective clinical study.

      Study population and sample size In total 84 Crohn's disease patients will be included in
      this study, divided into two groups. Group 1 (n=42) will consist of patients with disease in
      remission (quiescent disease); group 2 (n=42) will consist of patients with active disease.
      In this study an adaptive design will be used. First 12 patients in the disease in remission
      group will be analysed. The methods of analysis and safety aspects will be taken into
      account.

      Intervention Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin
      B2) during three weeks.
    

Intervention name(s): Riboflavin supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks
Other intervention name(s): vitamin B2 supplementation
Intervention MeSH terms: Riboflavin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Riboflavin (vitamin B2); Faecalibacterium prausnitzii