Status:
COMPLETED
Dietary Treatment of Crohn's Disease
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Crohn's Disease
Inflammatory Bowel Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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...
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 investi...
Eligibility Criteria
Inclusion
- Documented ileocolonic or colonic CD based on classical history and classical endoscopic or surgical findings and histology compatible with CD;
- Induction of remission with medical therapy within 9 months of the study;
- Inactive CD for at least 2 weeks with CDAI score less than 150;
- No change in IBD medication doses for 3 months;
- 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
- Patients with history of bowel obstruction and/or known strictures (as the high fiber content may precipitate obstruction);
- Patients with extensive colonic or ileocolonic resection;
- Patients with ileostomies or colostomies with diverted fecal stream;
- Patients with isolated perianal/anorectal disease;
- Patients with surgically induced remission;
- Concomitant infection (e.g., C. difficile colitis);
- 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;
- Use of potential IBD exacerbators such as NSAIDs within 1 wk of the study;
- Acute illness requiring immediate hospitalization for CD or other reasons;
- Presence of symptomatic organic GI disease other than CD, hemorrhoids, hiatal hernia; GERD;
- 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);
- Presence of short bowel syndrome or severe malnutrition with ideal body weight less than or equal to 90% or predicted;
- Estimated survival \<1 year and Karnofsky performance status \<50%;
- Desire to become pregnant during study or current pregnancy or nursing;
- Desire to change smoking-status during the study;
- Daily use of anticoagulation and antiplatelet medications;
- Complicated IBD with anticipation of imminent surgical intervention during the term of the study;
- Inability to have a regular follow-up and comply with study requirements.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00343642
Start Date
September 1 2006
End Date
October 1 2012
Last Update
June 9 2021
Active Locations (2)
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1
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States, 31201
2
Rush University Medical Center
Chicago, Illinois, United States, 60612