Dietary Treatment of Crohn's Disease

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.

Inclusion Criteria:

1. Documented ileocolonic or colonic CD based on classical history and classical
endoscopic or surgical findings and histology compatible with CD;

2. Induction of remission with medical therapy within 9 months of the study;

3. Inactive CD for at least 2 weeks with CDAI score less than 150;

4. No change in IBD medication doses for 3 months;

5. No change in smoking habits a month prior to enrollment (because smoking may
exacerbate CD) and acceptance of not-changing smoking habits during the term of the
study).

Exclusion Criteria:

1. Patients with history of bowel obstruction and/or known strictures (as the high fiber
content may precipitate obstruction);

2. Patients with extensive colonic or ileocolonic resection;

3. Patients with ileostomies or colostomies with diverted fecal stream;

4. Patients with isolated perianal/anorectal disease;

5. Patients with surgically induced remission;

6. Concomitant infection (e.g., C. difficile colitis);

7. Use of antibiotics within 4 weeks, or steroids, herbal remedies or diet therapies
within 2 weeks of the onset of the trial or during the study;

8. Use of potential IBD exacerbators such as NSAIDs within 1 wk of the study;

9. Acute illness requiring immediate hospitalization for CD or other reasons;

10. Presence of symptomatic organic GI disease other than CD, hemorrhoids, hiatal hernia;
GERD;

11. Pre-existent organ failure or severe comorbidities as these may change Gl flora:

- Liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X>
normal);

- Kidney disease (creatinine>2.0 mg/dL);

- Uncontrolled psychiatric illness;

- Clinically important lung disease or heart failure;

- HIV disease;

- Alcoholism;

- Transplant recipients;

- Patients receiving other immunosuppressant medications for comorbidities (e.g.
Enbrel for rheumatoid arthritis);

12. Presence of short bowel syndrome or severe malnutrition with ideal body weight less
than or equal to 90% or predicted;

13. Estimated survival <1 year and Karnofsky performance status <50%;

14. Desire to become pregnant during study or current pregnancy or nursing;

15. Desire to change smoking-status during the study;

16. Daily use of anticoagulation and antiplatelet medications;

17. Complicated IBD with anticipation of imminent surgical intervention during the term of
the study;

18. Inability to have a regular follow-up and comply with study requirements.