A Dietary Intervention Study on the Microbiome in Crohn's Disease Patients
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      This protocol is designed to compare the effectiveness of a soy-based diet or identical diet
      without soy given to patients with Crohn's disease (CD) in remission, patients with active
      CD, or healthy controls. The assigned diet will be compared to participant 'baseline'
      (pre-diet) in terms of its ability to change the gut bacteria and fecal butyrate, an
      important short-chain fatty acid (SCFA) that limits bowel inflammation, a characteristic of
      this debilitating disease.
    

Detailed description: 
      The inflammatory bowel disease (IBD) subtype, Crohn's disease (CD) is a chronic and relapsing
      inflammatory disorder of the gastrointestinal tract. Although the precise etiology of IBD is
      not known, evidence suggests that environmental factors, including diet, contribute to its
      pathogenesis. A soy-based diet has been demonstrated to have numerous health benefits. This
      single-center open-label study will compare the effectiveness of a soy-based diet or an
      identical diet without soy to change the gut microbiota composition and fecal butyrate
      concentration to that of baseline (pre-diet) in patients with CD (remission or active
      disease) and healthy control subjects without CD. Participants will follow either a soy-based
      diet or an identical diet without soy to which they will be randomized for 7 days. No data
      collection or other study procedures will take place until the potential participant provides
      written informed consent to participate in the research study. The informed consent,
      screening, enrollment, and baseline data collection which make up visit 1 can occur on the
      same day or be completed across several days.
    

Intervention name(s): Soy based diet; Non-soy based diet
Intervention type(s): Other; Other
Intervention description(s): The diet will be based on the detailed descriptions according to the American Heart Association, US Food and Drug Administration (FDA), and the Soyfoods Association of North America Website, which all promote soy products as having beneficial nutrient profiles with a daily consumption of 25 grams or more of soy protein (average serving = 6.25 grams), upper limit of 50g.; Diet of identical composition to the soy diet with the exception of soy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is an open label single center study to compare the effect of a soy-based diet or an identical diet without soy on the composition and metabolite production of gut bacteria in Crohn's disease (CD) patients in remission or active disease, and in healthy controls. Crohn's subjects will be pre-screened by the treating gastroenterologist for eligibility criteria during their normally scheduled appointment. The treating gastroenterologist will ask suitable patients whether they are interested in participating in the described dietary intervention study during the patient appointment. Initial verbal consent will be obtained by the treating gastroenterologist. Healthy controls will be recruited in the same manner, as well as via a hospital flyer advertisement. Subjects will then be contacted by the study investigator to schedule a screening visit (visit 1) and if study eligibility is confirmed, and informed consent provided, enrolled into the study.
Masking: None (Open Label)
Primary purpose: Other
Keywords: diet; inflammatory bowel disease; gut microbiome