Dietary Treatment of Crohn's Disease

• ClinicalTrials.gov Identifier: NCT00343642
• Recruitment Status: Completed
• First Posted: June 23, 2006
• Results First Posted: June 9, 2021
• Last Update Posted: June 9, 2021
• Sponsor: Rush University Medical Center
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Rush University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Crohn's Disease; Inflammatory Bowel Disease	Drug: Active fructo-oligosaccharide; Drug: Placebo fructo-oligosaccharide; Dietary Supplement: Diet	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Dietary Treatment of Crohn's Disease
• Study Start Date: September 2006
• Actual Primary Completion Date: October 2012
• Actual Study Completion Date: October 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active Fructo-oligosaccharide; Subjects received an active fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans. The fructo-oligosaccharide supplement was administered orally in a powder form two teaspoons daily.	Drug: Active fructo-oligosaccharide; 2 teaspoons of active fructo-oligosaccharides daily and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans; Other Names: Active fructooligosaccharide (FOS) and Placebo Diet; Time and Attention and Active Fructooligosaccharide
Placebo Comparator: Placebo Fructo-oligosaccharide; Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.	Drug: Placebo fructo-oligosaccharide; 2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily) and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans; Other Names: Placebo Diet and Placebo Supplement; Tiem and Attention and Fructooligosaccharide Placebo
Active Comparator: Dietary Therapy; Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team.	Dietary Supplement: Diet; A restrictive anti-inflammatory diet developed by the research team and 2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily); Other Names: Active Dietary Intervention and Placebo Supplement; Dietary Treatment and Fructooligosaccharide Placebo

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Flare Up of Crohn's Disease Through Month 12 [ Time Frame: Up to 12 months ]
   The efficacy of the dietary treatment was assessed by looking at the number of participants who flared.
2. Quality of Life in Patients Taking Dietary Treatments [ Time Frame: At exit visit of study ]
   Inflammatory Bowel Disease Questionnaire (IBDQ) overall scores at the exit visit of the study.It consists of 32 questons divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.
3. Safety of Dietary Treatments [ Time Frame: 90 days ]
   Data not collected

Secondary Outcome Measures :

1. Changes in Ileocolonic Flora [ Time Frame: 90 days ]
   Data not collected

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

National Center for Complementary and Integrative Health (NCCIH)

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

• Responsible Party: Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT00343642
• Other Study ID Numbers: R21AT001628-01A2 ( U.S. NIH Grant/Contract ); R21AT001628-01A2 ( U.S. NIH Grant/Contract )
• First Posted: June 23, 2006
• Results First Posted: June 9, 2021
• Last Update Posted: June 9, 2021
• Last Verified: May 2021

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; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases