View Clinical Trial (Medical Research Study)
Dietary Treatment of Crohn's Disease - NCT00343642-60612(Clinical Trial 146092)
ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.
| City: |
|
Chicago |
|
State:
|
|
IL |
| Zip Code: |
|
60612 |
| Conditions: |
|
Crohn's Disease - Inflammatory Bowel Disease |
| 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 (CD.
|
| Study summary: |
|
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. |
| 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. |
|
|
|
| Study is available at: |
|
Rush University Medical Center
Chicago, IL 60612
United States
Primary Contact:
Susan L Mikolaitis, RD
Email: Sue_L_Mikoalitis@rush.edu
Phone: 312-563-3892
Secondary Contact:
Susan L Mikoalitis, RD, LDN
Email: Sue_L_Mikolaitis@rush.edu
Phone: 312 563 3892 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 21, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|