Dietary Control of Fat to Modify Colonic Inflammation in Ulcerative Colitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change in quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ).
Study Overview
Brief Summary
The primary purpose of this study is to determine the effectiveness of a low-fat or standard American diet (high in fat) in helping people with ulcerative colitis improve their symptoms and the signs of inflammation in blood tests and in bowel biopsies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or Female ≥18 and ≤70 years old
- •History of UC of at least 3 months duration
- •UC should be confirmed by colonoscopy within two years of entry into the study
- •Patients with mild to moderate UC, or patients in remission that have had active disease within the past 18 months, regardless of treatment with mesalamines, immunosuppressants, anti-TNFs and/or vedolizumab
- •Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥2 weeks prior to screening
- •Patients treated with anti-TNFs or immunosuppressants (AZA, 6-MP, or methotrexate) at screening must have been on a stable dose for ≥8 weeks and remain on the same dose during the treatment period
- •Patients on steroids can be on no more than prednisone 20mg daily or budesonide 9mg daily at screening. If clinically indicated, tapering of steroids after 4 weeks of intervention may occur. Prednisone may be tapered by no more than 2.5mg/week and budesonide by no more than 3mg/week.
- •Patients on infliximab, premedication may include intravenous corticosteroid
- •No antibiotic use or probiotic use within 4 weeks prior to screening
- •Signed written informed consent for enrollment into the study
Exclusion Criteria
- •Patients with Crohn's Disease and Celiac Disease
- •History of colonic dysplasia except for adenoma on prior surveillance colonoscopy
- •Patients with altered anatomy: prior colectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
- •Clinical manifestations concerning for fulminant disease or toxic megacolon
- •Patients with stool sample positive at during screening period or at least <12 weeks for ova, parasites, or culture for aerobic pathogens including: Aeromonas, Plesiomonas, Shigella, Yersinia, Campylobacter and E.coli spp. or positive for Clostridium difficile B toxin in stools
- •Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
- •Need for prednisone >20mg daily or budesonide >9mg daily at the time of screening
- •Received intravenous corticosteroids within 2 weeks prior to screening, during screening, or during the study period, except as premedication for anti-TNFs
- •Use of Total Parenteral Nutrition at the time of screening and during the study period
- •Anti-diarrheal use within 2 weeks prior to screening
- •Presence of any of the following laboratory abnormalities during screening period or at least <12 weeks
- •Hemoglobin <8.0g/dl
- •Albumin <2.8g/dl
- •Conditions/situations such as:
- •Patients with short life expectancy
- •Uncooperative behavior or any condition that could make the patient potentially non-compliant to the study procedures
- •Patients with pacemaker
- •Other significant or life-threatening co-morbidities in which diet intervention could negatively affect
- •Failure to meet any of the inclusion criteria
- •Poor compliance with diet during the study period
- •Failure to submit stool samples as indicated at each phase of the study
- •The need for antibiotic use during the study period
Arms & Interventions
Low Fat Diet (LFD) to Standard American Diet (SAD)
Week 1 to 4 participants will receive a LFD followed by a washout period of 2 weeks and then week 6 to 10 SAD.
Intervention: LFD (Other)
Low Fat Diet (LFD) to Standard American Diet (SAD)
Week 1 to 4 participants will receive a LFD followed by a washout period of 2 weeks and then week 6 to 10 SAD.
Intervention: SAD (Other)
SAD to LFD
Week 1 to 4 participants will receive a SAD followed by a washout period of 2 weeks and then week 6 to 10 LFD.
Intervention: LFD (Other)
SAD to LFD
Week 1 to 4 participants will receive a SAD followed by a washout period of 2 weeks and then week 6 to 10 LFD.
Intervention: SAD (Other)
Outcomes
Primary Outcomes
Change in quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ).
Time Frame: Baseline, 4 weeks
sIBDQ is a 10-item shortened version of the original IBDQ assessing quality of life (QOL) with total scores ranging from 1 to 7 with a higher score indicating a better QOL.
Change in quality of life as measured by the Food-Related Quality of Life (FR-QoL-29) Questionnaire.
Time Frame: Baseline, 4 weeks
FR-QoL-29 is a 29-item questionnaire assessing quality of life (QOL) with total scores ranging from 29 to 145 with a score less than 90 suggesting poor food related QoL.
Change in the expression of inflammatory markers in the colon.
Time Frame: Baseline, 4 weeks
Change in the expression of interleukin (IL)-1β, IL-6 and Tumor Necrosis Factor alpha (TNFa) evaluated in pg/mL.
Change in quality of life as measured by the Medical Outcomes Short Form-36 (SF-36) Questionnaire.
Time Frame: Baseline, 4 weeks
SF-36 is a 36-item questionnaire assessing quality of life (QOL) with total scores ranging from 0 to 100 with a higher score indicating a better QOL.
Change in the expression of cytokine in the colon.
Time Frame: Baseline, 4 weeks
Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluted in mg/L.
Change in intestinal microbiota
Time Frame: Baseline, 4 weeks
Change in relative abundance of the microbial communities evaluated as a percentage.
Secondary Outcomes
- Rate of adherence to fat intake(Baseline, 4 weeks)
- Change in Ulcerative Colitis (UC) symptoms as measured by the partial Mayo score(Baseline, 4 weeks)
- Change in UC symptoms as measured by the Simple Clinical Colitis Activity Index (SCCAI)(Baseline, 4 weeks)
- Rate of adherence to diet items(Baseline, 4 weeks)
Investigators
Maria Abreu
Professor of Medicine
University of Miami