Crohn's Disease Clinical Trial
Official title:
Dietary Treatment of Crohn's Disease
Verified date | May 2021 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 73 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
United States | Gastroenterology Associates of Central Georgia | Macon | Georgia |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Flare Up of Crohn's Disease Through Month 12 | The efficacy of the dietary treatment was assessed by looking at the number of participants who flared. | Up to 12 months | |
Primary | Quality of Life in Patients Taking Dietary Treatments | Inflammatory Bowel Disease Questionnaire (IBDQ) overall scores at the exit visit of the study.It consists of 32 questons divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life. | At exit visit of study | |
Primary | Safety of Dietary Treatments | Data not collected | 90 days | |
Secondary | Changes in Ileocolonic Flora | Data not collected | 90 days |
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