Dietary Treatment of Crohn's Disease - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00343642

Purpose

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
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

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Dietary Supplements

Drug Information available for: Inulin Fructooligosaccharides

U.S. FDA Resources

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

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Efficacy of dietary treatment in maintaining remission of Crohn's disease [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Quality of life in patients taking dietary treatments [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Safety of dietary treatments [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Utility of dietary treatments for patients [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Changes in ileocolonic flora [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Changes in colonic oxidative stress [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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
1: Placebo Comparator Time and attention + fructooligosaccharide placebo	Dietary Supplement: Time and attention + fructooligosaccharide placebo as stated
2: Active Comparator Dietary therapy + fructooligosaccharide placebo	Dietary Supplement: dietary therapy + fructooligosaccharide placebo i.e., standard of care
3: Experimental Time and attention + active fructooligosaccharide supplement.	Dietary Supplement: Time and attention + active fructooligosaccharide supplementation as stated

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. 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 medically by either steroids or by infliximab therapy within 3 months of the study;
Inactive CD for at least 2 weeks with CDAI < 150;
No IBD medication use medication use except 5-ASA, because: the patients are either intolerant to medications (side effects), or had flare-up while taking medications (ineffective therapy), or are unwilling to take daily medication;
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, mesalamine, or 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;
Use or need of infliximab (TNF antibody), azathioprine, methotrexate, or mycophenolate mofetil within 12 weeks 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;
Pre-existent organ failure or severe comorbidities as these may change Gl flora:
1. Liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X> normal);
2. Kidney disease (creatinine>2.0 mg/dL);
3. Uncontrolled psychiatric illness;
4. Clinically important lung disease or heart failure;
5. HIV disease;
6. Alcoholism;
7. Transplant recipients;
8. 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 < or = 90%;
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343642

Contacts

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

Locations

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

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:	Ece A Mutlu, MD MBA	Rush University Medical Center
Study Chair:	Ali Keshavarzian, MD	Rush University Medical Center

More Information

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

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Crohn's disease
Fructooligosaccharide
Inulin
Diet

Treatment
Bacterial flora
Oxidative stress

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease
Stress

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 30, 2009