Dietary Treatment of Crohn's Disease
Crohn's Disease, Inflammatory Bowel Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, Fructooligosaccharide, Inulin, Diet, Treatment, Bacterial flora, Oxidative stress
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Gastroenterology Associates of Central Georgia
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Active Comparator
Active Fructo-oligosaccharide
Placebo Fructo-oligosaccharide
Dietary Therapy
Subjects received an active fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans. The fructo-oligosaccharide supplement was administered orally in a powder form two teaspoons daily.
Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.
Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team.