Clinical trial NCT04147598: Diet Study on Ulcerative Colitis
Official title: Dietary Control of Fat to Modify Colonic Inflammation in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Inflammatory bowel disease
diet
low fat
UC
IBD
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Broad Medical Research Program Crohn's and Colitis Foundation
First posted: 2019-11-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

1. Male or Female ≥18 and ≤70 years old
2. History of UC of at least 3 months duration
3. UC should be confirmed by colonoscopy within two years of entry into the study
4. 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
5. No antibiotic use or probiotic use within 4 weeks prior to screening
6. Signed written informed consent for enrollment into the study

Exclusion Criteria:

1. Patients with Crohn's Disease and Celiac Disease
2. History of colonic dysplasia except for adenoma on prior surveillance colonoscopy
3. Patients with altered anatomy: prior colectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
4. Clinical manifestations concerning for fulminant disease or toxic megacolon
5. 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
6. Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
7. Need for prednisone \>20mg daily or budesonide \>9mg daily at the time of screening
8. Received intravenous corticosteroids within 2 weeks prior to screening, during screening, or during the study period, except as premedication for anti-TNFs
9. Use of Total Parenteral Nutrition at the time of screening and during the study period
10. Anti-diarrheal use within 2 weeks prior to screening
11. Presence of any of the following laboratory abnormalities during screening period or at least \<12 weeks

    * Hemoglobin \<8.0g/dl
    * Albumin \<2.8g/dl
12. 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
13. Failure to meet any of the inclusion criteria
14. Poor compliance with diet during the study period
15. Failure to submit stool samples as indicated at each phase of the study
16. The need for antibiotic use during the study period

Primary outcomes:
measure: Change in quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ).
timeFrame: Baseline, 4 weeks
measure: Change in quality of life as measured by the Food-Related Quality of Life (FR-QoL-29) Questionnaire.
timeFrame: Baseline, 4 weeks
measure: Change in quality of life as measured by the Medical Outcomes Short Form-36 (SF-36) Questionnaire.
timeFrame: Baseline, 4 weeks
measure: Change in the expression of inflammatory markers in the colon.
timeFrame: Baseline, 4 weeks
measure: Change in the expression of cytokine in the colon.
timeFrame: Baseline, 4 weeks
measure: Change in intestinal microbiota
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change in Ulcerative Colitis (UC) symptoms as measured by the partial Mayo score
timeFrame: Baseline, 4 weeks
measure: Change in UC symptoms as measured by the Simple Clinical Colitis Activity Index (SCCAI)
timeFrame: Baseline, 4 weeks
measure: Rate of adherence to fat intake
timeFrame: Baseline, 4 weeks
measure: Rate of adherence to diet items
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Maria Abreu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fritsch J, Garces L, Quintero MA, Pignac-Kobinger J, Santander AM, Fernandez I, Ban YJ, Kwon D, Phillips MC, Knight K, Mao Q, Santaolalla R, Chen XS, Maruthamuthu M, Solis N, Damas OM, Kerman DH, Deshpande AR, Lewis JE, Chen C, Abreu MT. Low-Fat, High-Fiber Diet Reduces Markers of Inflammation and Dysbiosis and Improves Quality of Life in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1189-1199.e30. doi: 10.1016/j.cgh.2020.05.026. Epub 2020 May 20.