Dietary Treatment of Crohn's Disease
Condition: Crohn's Disease; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Our objective is to determine whether a specific dietary intervention or a
      fructooligosaccharide (FOS) supplement has anti-oxidant or prebiotic effects and whether it
      is beneficial in the treatment of Crohn's Disease (CD.
    

Detailed description: 
      Several epidemiological studies and therapeutic observations in the complementary and
      alternative medicine (CAM) literature suggest that diet is key to development of CD and its
      treatment. The investigators took advantage of these CAM recommendations and designed dietary
      interventions. Our preliminary open label studies in IBD patients showed that our
      interventions are acceptable and well-tolerated and result in improvement, reducing symptoms
      and/or the degree of inflammation. The investigators are now seeking to validate this finding
      and determine the mechanisms underlying the effects of dietary manipulation-such as potential
      effects on colonic bacterial microflora. In another pilot study using 16s rDNA bacterial
      fingerprinting, the investigators demonstrated that the intestinal microflora of patients
      with CD differ significantly from healthy individuals. Whether the investigators can
      normalize/change the microflora of CD patients with dietary therapies, however, remains to be
      determined. Accordingly, the investigators designed a double blind placebo controlled study
      to test the hypotheses that: (1) dietary manipulation with either diet or a FOS supplement is
      an effective CAM therapy that prevents CD relapse (leads to maintenance of remission) and (2)
      such dietary manipulation can normalize the microflora of CD patients and decrease mucosal
      oxidative damage.

      90 participants are expected to undergo the trial and have a 2:1 chance of receiving active
      therapy. The trial is seeking to enroll participants with inactive CD who have been medically
      induced into remission within 9 months of enrollment. Participants must be on their Crohn's
      medications at a stable dose for 3 months, which does not include steroids (e.g. Prednisone,
      Entocort) or antibiotics at the time of enrollment. Participants will be followed till
      relapse occurs or up to 52 weeks. Participants are asked to fill out a variety of
      questionnaires, keep a food and adverse event diary, and have a research, limited, unprepped
      flexible sigmoidoscopy for colonic tissue collection at the beginning and end of the study
      period.

      Significance. This study could provide information to suggest diet or dietary supplement as a
      safe therapy for IBD and lay the groundwork for more definitive, randomized, controlled
      trials.
    

Intervention name(s): Active fructo-oligosaccharide; Placebo fructo-oligosaccharide; Diet
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): 2 teaspoons of active fructo-oligosaccharides daily and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans; 2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily) and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans; A restrictive anti-inflammatory diet developed by the research team and 2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily)
Other intervention name(s): Active fructooligosaccharide (FOS) and Placebo Diet; Time and Attention and Active Fructooligosaccharide; Placebo Diet and Placebo Supplement; Tiem and Attention and Fructooligosaccharide Placebo; Active Dietary Intervention and Placebo Supplement; Dietary Treatment and Fructooligosaccharide Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Crohn's disease; Fructooligosaccharide; Inulin; Diet; Treatment; Bacterial flora; Oxidative stress