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Diet Study on Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT04147598
Recruitment Status : Completed
First Posted : November 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
Broad Medical Research Program Crohn's and Colitis Foundation
Information provided by (Responsible Party):
Maria Abreu, University of Miami

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: LFD Other: SAD Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Dietary Control of Fat to Modify Colonic Inflammation in Ulcerative Colitis
Actual Study Start Date : February 25, 2015
Actual Primary Completion Date : September 11, 2018
Actual Study Completion Date : September 11, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: LFD
Participants will receive daily prepared food trays to achieve a diet with approximately 10% of total fat, 1-5% of calories from saturated fat, and 5-9% of MUFA and PUFA. This diet will contain an approximate ratio of 1:1 of omega-6/omega-3 fatty acids.

Other: SAD
Participants will receive daily prepared food trays to achieve a diet with approximately 35-40% of calories from fat, 10-11% of saturated fats, and 25-29% would be mono-unsaturated (MUFA) and PUFA. This diet will contain a 20-30:1 ratio of omega-6/omega-3 fatty acids, representing the current SAD.

Experimental: 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.
Other: LFD
Participants will receive daily prepared food trays to achieve a diet with approximately 10% of total fat, 1-5% of calories from saturated fat, and 5-9% of MUFA and PUFA. This diet will contain an approximate ratio of 1:1 of omega-6/omega-3 fatty acids.

Other: SAD
Participants will receive daily prepared food trays to achieve a diet with approximately 35-40% of calories from fat, 10-11% of saturated fats, and 25-29% would be mono-unsaturated (MUFA) and PUFA. This diet will contain a 20-30:1 ratio of omega-6/omega-3 fatty acids, representing the current SAD.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Change in intestinal microbiota [ Time Frame: Baseline, 4 weeks ]
    Change in relative abundance of the microbial communities evaluated as a percentage.


Secondary Outcome Measures :
  1. Change in Ulcerative Colitis (UC) symptoms as measured by the partial Mayo score [ Time Frame: Baseline, 4 weeks ]
    The partial Mayo score ranges from 0 to 9 with a higher score indicating worsening UC symptoms.

  2. Change in UC symptoms as measured by the Simple Clinical Colitis Activity Index (SCCAI) [ Time Frame: Baseline, 4 weeks ]
    SCCAI score ranges from 0 to 19 with a higher score indicating worsening UC symptoms.

  3. Rate of adherence to fat intake [ Time Frame: Baseline, 4 weeks ]
    Adherence to fat intake is measured by the web-based daily food diary software Nutrihand.

  4. Rate of adherence to diet items [ Time Frame: Baseline, 4 weeks ]
    Adherence to diet items is measured by the web-based daily food diary software Nutrihand.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147598


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Broad Medical Research Program Crohn's and Colitis Foundation
Investigators
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Principal Investigator: Maria Abreu, MD University of Miami
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Abreu, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT04147598    
Other Study ID Numbers: 20130716
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Abreu, University of Miami:
Inflammatory bowel disease
diet
low fat
UC
IBD
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases