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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00343642 |
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.
Condition | Intervention | Phase |
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Crohn's Disease Inflammatory Bowel Disease |
Dietary Supplement: Time and attention + fructooligosaccharide placebo Dietary Supplement: dietary therapy + fructooligosaccharide placebo Dietary Supplement: Time and attention + active fructooligosaccharide supplementation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Dietary Treatment of Crohn's Disease |
Estimated Enrollment: | 90 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Time and attention + fructooligosaccharide placebo
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Dietary Supplement: Time and attention + fructooligosaccharide placebo
as stated
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2: Active Comparator
Dietary therapy + fructooligosaccharide placebo
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Dietary Supplement: dietary therapy + fructooligosaccharide placebo
i.e., standard of care
|
3: Experimental
Time and attention + active fructooligosaccharide supplement.
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Dietary Supplement: Time and attention + active fructooligosaccharide supplementation
as stated
|
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. We 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. We 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, we demonstrated that the intestinal microflora of patients with CD differ significantly from healthy individuals. Whether we can normalize/change the microflora of CD patients with dietary therapies, however, remains to be determined. Accordingly, we 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 patients are expected to undergo the trial and have a 2:1 chance of receiving active therapy. The trial is seeking to enroll patients with inactive CD who have been medically induced into remission within 3 months of enrollment. Subjects are allowed to be on 5-ASA. Subjects will be followed till relapse occurs or up to 52 weeks. Subjects are asked to fill out a variety of questionnaires, keep a food and adverse event diary, and have colonoscopy or flexible sigmoidoscopy for colonic tissue collection at the beginning and end of the study period.
Significance. This study could provide information to suggest diet as a safe therapy for IBD and lay the groundwork for more definitive, randomized, controlled trials.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pre-existent organ failure or severe comorbidities as these may change Gl flora:
Contact: Susan L Mikoalitis, RD | 312 563 3892 | Sue_L_Mikolaitis@rush.edu |
Contact: Ece A Mutlu, MD MBA | 312 942 5861 | Ece_Mutlu@rush.edu |
United States, Illinois | |
Rush University Medical Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Susan L Mikolaitis, RD 312-563-3892 Sue_L_Mikoalitis@rush.edu | |
Contact: Ece A Mutlu, MD, MBA 312 942 5861 Ece_Mutlu@rush.edu | |
Principal Investigator: Ece A Mutlu, MD MBA | |
Sub-Investigator: Ali Keshavarzian, MD |
Principal Investigator: | Ece A Mutlu, MD MBA | Rush University Medical Center |
Study Chair: | Ali Keshavarzian, MD | Rush University Medical Center |
Responsible Party: | Rush University Medical Center ( Ece A. Mutlu, MD ) |
Study ID Numbers: | R21 AT001628-01A2, R21 AT001628-01A2 |
Study First Received: | June 21, 2006 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00343642 |
Health Authority: | United States: Federal Government |
Crohn's disease Fructooligosaccharide Inulin Diet |
Treatment Bacterial flora Oxidative stress |
Digestive System Diseases Gastrointestinal Diseases Crohn Disease Stress |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |