Clinical trial NCT00343642: Dietary Treatment of Crohn's Disease
Official title: Dietary Treatment of Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Crohn's Disease
Inflammatory Bowel Disease
Keywords: Crohn's disease
Fructooligosaccharide
Inulin
Diet
Treatment
Bacterial flora
Oxidative stress
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2006-06-23
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Crohn's Disease (CD.

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 investigators 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. The investigators 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, the investigators demonstrated that the intestinal microflora of patients with CD differ significantly from healthy individuals. Whether the investigators can normalize/change the microflora of CD patients with dietary therapies, however, remains to be determined. Accordingly, the investigators 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 participants are expected to undergo the trial and have a 2:1 chance of receiving active therapy. The trial is seeking to enroll participants with inactive CD who have been medically induced into remission within 9 months of enrollment. Participants must be on their Crohn's medications at a stable dose for 3 months, which does not include steroids (e.g. Prednisone, Entocort) or antibiotics at the time of enrollment. Participants will be followed till relapse occurs or up to 52 weeks. Participants are asked to fill out a variety of questionnaires, keep a food and adverse event diary, and have a research, limited, unprepped flexible sigmoidoscopy for colonic tissue collection at the beginning and end of the study period.

Significance. This study could provide information to suggest diet or dietary supplement as a safe therapy for IBD and lay the groundwork for more definitive, randomized, controlled trials.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Flare Up of Crohn's Disease Through Month 12
timeFrame: Up to 12 months
measure: Quality of Life in Patients Taking Dietary Treatments
timeFrame: At exit visit of study
measure: Safety of Dietary Treatments
timeFrame: 90 days
Secondary outcomes:
measure: Changes in Ileocolonic Flora
timeFrame: 90 days
Other outcomes:
Locations:
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Ece A Mutlu, MD MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Ali Keshavarzian, MD
role: STUDY_DIRECTOR
affiliation: Gastroenterology Associates of Central Georgia
name: Shahriar Sedghi, MD
role: STUDY_DIRECTOR
References: