Mode
Text Size
Log in / Sign up
Phase 2 N=54 Randomized Triple-blind Treatment

Dietary Treatment of Crohn's Disease

Crohn's Disease · Inflammatory Bowel Disease

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search