Dietary Treatment of Crohn's Disease

NCT ID: NCT00343642

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2012-10-31

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.

Conditions

Crohn's Disease; Inflammatory Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active fructo-oligosaccharide

Intervention Type: DRUG

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

Placebo Fructo-oligosaccharide

Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.

Group Type: PLACEBO_COMPARATOR

Placebo fructo-oligosaccharide

Intervention Type: DRUG

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

Dietary Therapy

Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team.

Group Type: ACTIVE_COMPARATOR

Diet

Intervention Type: DIETARY_SUPPLEMENT

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)

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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)

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Active fructooligosaccharide (FOS) and Placebo Diet; Time and Attention and Active Fructooligosaccharide; Placebo Diet and Placebo Supplement; Tiem and Attention and Fructooligosaccharide Placebo; Active Dietary Intervention and Placebo Supplement; Dietary Treatment and Fructooligosaccharide Placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ece A Mutlu, MD MBA

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Ali Keshavarzian, MD

Role: STUDY_DIRECTOR

Rush University Medical Center

Shahriar Sedghi, MD

Role: STUDY_DIRECTOR

Gastroenterology Associates of Central Georgia

Locations

Gastroenterology Associates of Central Georgia

Macon, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

R21AT001628-01A2

Identifier Type: NIH

Identifier Source: secondary_id

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R21AT001628-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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