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Dietary Treatment of Crohn's Disease

Primary Purpose

Crohn's Disease, Inflammatory Bowel Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Active fructo-oligosaccharide
Placebo fructo-oligosaccharide
Diet
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, Fructooligosaccharide, Inulin, Diet, Treatment, Bacterial flora, Oxidative stress

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Documented ileocolonic or colonic CD based on classical history and classical endoscopic or surgical findings and histology compatible with CD; Induction of remission with medical therapy within 9 months of the study; Inactive CD for at least 2 weeks with CDAI score less than 150; No change in IBD medication doses for 3 months; 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: Patients with history of bowel obstruction and/or known strictures (as the high fiber content may precipitate obstruction); Patients with extensive colonic or ileocolonic resection; Patients with ileostomies or colostomies with diverted fecal stream; Patients with isolated perianal/anorectal disease; Patients with surgically induced remission; Concomitant infection (e.g., C. difficile colitis); 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; Use of potential IBD exacerbators such as NSAIDs within 1 wk of the study; Acute illness requiring immediate hospitalization for CD or other reasons; Presence of symptomatic organic GI disease other than CD, hemorrhoids, hiatal hernia; GERD; 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); Presence of short bowel syndrome or severe malnutrition with ideal body weight less than or equal to 90% or predicted; Estimated survival <1 year and Karnofsky performance status <50%; Desire to become pregnant during study or current pregnancy or nursing; Desire to change smoking-status during the study; Daily use of anticoagulation and antiplatelet medications; Complicated IBD with anticipation of imminent surgical intervention during the term of the study; Inability to have a regular follow-up and comply with study requirements.

Sites / Locations

  • Gastroenterology Associates of Central Georgia
  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Active Fructo-oligosaccharide

Placebo Fructo-oligosaccharide

Dietary Therapy

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Number of Participants With Flare Up of Crohn's Disease Through Month 12
The efficacy of the dietary treatment was assessed by looking at the number of participants who flared.
Quality of Life in Patients Taking Dietary Treatments
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.
Safety of Dietary Treatments
Data not collected

Secondary Outcome Measures

Changes in Ileocolonic Flora
Data not collected

Full Information

First Posted
June 21, 2006
Last Updated
May 13, 2021
Sponsor
Rush University Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00343642
Brief Title
Dietary Treatment of Crohn's Disease
Official Title
Dietary Treatment of Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Inflammatory Bowel Disease
Keywords
Crohn's disease, Fructooligosaccharide, Inulin, Diet, Treatment, Bacterial flora, Oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Fructo-oligosaccharide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Fructo-oligosaccharide
Arm Type
Placebo Comparator
Arm Description
Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.
Arm Title
Dietary Therapy
Arm Type
Active Comparator
Arm Description
Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team.
Intervention Type
Drug
Intervention Name(s)
Active fructo-oligosaccharide
Other Intervention Name(s)
Active fructooligosaccharide (FOS) and Placebo Diet, Time and Attention and Active Fructooligosaccharide
Intervention Description
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
Intervention Name(s)
Placebo fructo-oligosaccharide
Other Intervention Name(s)
Placebo Diet and Placebo Supplement, Tiem and Attention and Fructooligosaccharide Placebo
Intervention Description
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
Dietary Supplement
Intervention Name(s)
Diet
Other Intervention Name(s)
Active Dietary Intervention and Placebo Supplement, Dietary Treatment and Fructooligosaccharide Placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of Participants With Flare Up of Crohn's Disease Through Month 12
Description
The efficacy of the dietary treatment was assessed by looking at the number of participants who flared.
Time Frame
Up to 12 months
Title
Quality of Life in Patients Taking Dietary Treatments
Description
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.
Time Frame
At exit visit of study
Title
Safety of Dietary Treatments
Description
Data not collected
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Changes in Ileocolonic Flora
Description
Data not collected
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented ileocolonic or colonic CD based on classical history and classical endoscopic or surgical findings and histology compatible with CD; Induction of remission with medical therapy within 9 months of the study; Inactive CD for at least 2 weeks with CDAI score less than 150; No change in IBD medication doses for 3 months; 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: Patients with history of bowel obstruction and/or known strictures (as the high fiber content may precipitate obstruction); Patients with extensive colonic or ileocolonic resection; Patients with ileostomies or colostomies with diverted fecal stream; Patients with isolated perianal/anorectal disease; Patients with surgically induced remission; Concomitant infection (e.g., C. difficile colitis); 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; Use of potential IBD exacerbators such as NSAIDs within 1 wk of the study; Acute illness requiring immediate hospitalization for CD or other reasons; Presence of symptomatic organic GI disease other than CD, hemorrhoids, hiatal hernia; GERD; 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); Presence of short bowel syndrome or severe malnutrition with ideal body weight less than or equal to 90% or predicted; Estimated survival <1 year and Karnofsky performance status <50%; Desire to become pregnant during study or current pregnancy or nursing; Desire to change smoking-status during the study; Daily use of anticoagulation and antiplatelet medications; Complicated IBD with anticipation of imminent surgical intervention during the term of the study; Inability to have a regular follow-up and comply with study requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ece A Mutlu, MD MBA
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Keshavarzian, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shahriar Sedghi, MD
Organizational Affiliation
Gastroenterology Associates of Central Georgia
Official's Role
Study Director
Facility Information:
Facility Name
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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Dietary Treatment of Crohn's Disease

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