Dietary Treatment of Crohn's Disease

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)

Criteria

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.