Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dietary Treatment of Crohn's Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00343642
First received: June 21, 2006
Last updated: January 24, 2014
Last verified: January 2014
  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.


Condition Intervention Phase
Crohn's Disease
Inflammatory Bowel Disease
Dietary Supplement: Time and attention + fructo-oligosaccharide placebo
Dietary Supplement: dietary therapy + fructo-oligosaccharide placebo
Drug: Time and attention + active fructooligosaccharide supplementation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Dietary Treatment of Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

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 ]

Enrollment: 73
Study Start Date: September 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Time and attention + fructooligosaccharide placebo
Dietary Supplement: Time and attention + fructo-oligosaccharide placebo
2 teaspoons of placebo powder daily
Active Comparator: 2
Dietary therapy + fructooligosaccharide placebo
Dietary Supplement: dietary therapy + fructo-oligosaccharide placebo
Medical nutrition therapy and 2 teaspoons of placebo powder
Experimental: 3
Time and attention + active fructooligosaccharide supplement.
Drug: Time and attention + active fructooligosaccharide supplementation
2 teaspoons of fructooligosaccharides daily

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States, 31201
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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
  More Information

No publications provided

Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00343642     History of Changes
Other Study ID Numbers: R21 AT001628-01A2, R21AT001628-01A2, R21 AT001628-01A2
Study First Received: June 21, 2006
Last Updated: January 24, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Rush University Medical Center:
Crohn's disease
Fructooligosaccharide
Inulin
Diet
Treatment
Bacterial flora
Oxidative stress

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014