Phase 2
N=54
Dietary Treatment of Crohn's Disease
Crohn's Disease · Inflammatory Bowel Disease
Bottom Line
View on ClinicalTrials.gov: NCT00343642 ↗Enrolled (actual)
54
Serious AEs
5.6%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Flare Up of Crohn's Disease Through Month 12 — 6; 4; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Active fructo-oligosaccharide (Drug); Placebo fructo-oligosaccharide (Drug); Diet (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Flare Up of Crohn's Disease Through Month 12 |
6; 4; 0 | — |
| PRIMARY Quality of Life in Patients Taking Dietary Treatments |
180.17; 197.42; 196 | — |
| PRIMARY Safety of Dietary Treatments |
— | — |
| SECONDARY Changes in Ileocolonic Flora |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00343642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.