Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dietary Treatment of Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00343642
Recruitment Status : Completed
First Posted : June 23, 2006
Last Update Posted : January 28, 2014
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE June 21, 2006
First Posted Date  ICMJE June 23, 2006
Last Update Posted Date January 28, 2014
Study Start Date  ICMJE September 2006
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2008)
  • Efficacy of dietary treatment in maintaining remission of Crohn's disease [ Time Frame: 90 days ]
  • Quality of life in patients taking dietary treatments [ Time Frame: 90 days ]
  • Safety of dietary treatments [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 21, 2006)
  • Efficacy of dietary treatment in maintaining remission of Crohn's disease
  • Quality of life in patients taking dietary treatments
  • Safety of dietary treatments
Change History Complete list of historical versions of study NCT00343642 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2008)
  • Utility of dietary treatments for patients [ Time Frame: 90 days ]
  • Changes in ileocolonic flora [ Time Frame: 90 days ]
  • Changes in colonic oxidative stress [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2006)
  • Utility of dietary treatments for patients
  • Changes in ileocolonic flora
  • Changes in colonic oxidative stress
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Treatment of Crohn's Disease
Official Title  ICMJE Dietary Treatment of Crohn's Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Crohn's Disease
  • Inflammatory Bowel Disease
Intervention  ICMJE
  • Dietary Supplement: Time and attention + fructo-oligosaccharide placebo
    2 teaspoons of placebo powder daily
  • Dietary Supplement: dietary therapy + fructo-oligosaccharide placebo
    Medical nutrition therapy and 2 teaspoons of placebo powder
  • Drug: Time and attention + active fructooligosaccharide supplementation
    2 teaspoons of fructooligosaccharides daily
Study Arms  ICMJE
  • Placebo Comparator: 1
    Time and attention + fructooligosaccharide placebo
    Intervention: Dietary Supplement: Time and attention + fructo-oligosaccharide placebo
  • Active Comparator: 2
    Dietary therapy + fructooligosaccharide placebo
    Intervention: Dietary Supplement: dietary therapy + fructo-oligosaccharide placebo
  • Experimental: 3
    Time and attention + active fructooligosaccharide supplement.
    Intervention: Drug: Time and attention + active fructooligosaccharide supplementation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2014)
73
Original Enrollment  ICMJE
 (submitted: June 21, 2006)
90
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00343642
Other Study ID Numbers  ICMJE R21AT001628-01A2( U.S. NIH Grant/Contract )
R21AT001628-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Ece A Mutlu, MD MBA Rush University Medical Center
Study Director: Ali Keshavarzian, MD Rush University Medical Center
Study Director: Shahriar Sedghi, MD Gastroenterology Associates of Central Georgia
PRS Account Rush University Medical Center
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP