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Low-Fat High-Fiber Diet for Crohn's Disease
Study Summary
This trial will study whether a low-fat, high-fiber diet can improve symptoms and quality of life in people with gastrointestinal issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with Crohn's Disease.I am between 18 and 70 years old and live with someone who shares my daily meals.Your Crohn's disease activity score is too low to be included in the study.I have been on a stable dose of TNFs or immunosuppressants for at least 4 weeks.I haven't taken antibiotics or probiotics in the last 2 weeks.I have been taking the same dose of my ulcerative colitis medication for at least 2 weeks.I am taking no more than 20 mg of prednisone or 9 mg of budesonide daily.
- Group 1: Crohn's Disease (CD) Control Group
- Group 2: Experimental CD Low Fat Diet (LFD) Group
- Group 3: Experimental CD LFD + DPS Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What specific criteria necessitate a person being eligible to enter this research project?
"This medical trial is enrolling 300 participants aged 18-70, who have ileocolitis. In addition to this condition, the patient must meet several other criteria: gender (male or female); live with another person involved in daily diet; documented diagnosis of Crohn's disease; sCDAI less than 400; stable doses of oral 5-aminosalicylates and mesalamine/sulfasalazine for 2 weeks prior to screening; stabilized doses of anti-Tumor Necrotic Factors (TNFs), immunosuppressants such as AZA, 6-Mercaptopurine (6"
Are there currently any open slots to participate in this medical experiment?
"Affirmative. Clinicaltrials.gov has verified that this medical trial is currently recruiting patients, which was first posted on November 26th 2019 and most recently edited on September 26th 2022. Three hundred participants are being sought from one clinical site."
What are the major goals of this research endeavor?
"This clinical trial's primary outcome, to be evaluated over a baseline 8 week period, is the Rate of adherence to fat intake. Furthermore, secondary outcomes include changes in Quality of Life (QoL) as assessed by Short Inflammation Bowel Disease Questionnaire (sIBDQ), High-Sensitivity C-Reactive Protein (hsCRP) expression levels measured in mg/L and Clinical Symptom severity graded through the Short Crohn's disease Activity Index (sCDAI)."
Can individuals aged 60 and above partake in this experimentation?
"This trial requires enrollees to be aged 18 and 70. Separate studies have been conducted for patients below the age of consent (n=69) and those over 65 years old (n=195)."
How many individuals are presently participating in this research trial?
"Right, clinicaltrials.gov data reveals that the study is currently recruiting participants. It was first listed on November 26th 2019 and its most recent edits were done on September 26th 2022. 300 patients are required to be enrolled at a single site."
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