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| Name | Class |
|---|---|
| Broad Medical Research Program Crohn's and Colitis Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Fat Diet (LFD) to Standard American Diet (SAD) | Experimental | Week 1 to 4 participants will receive a LFD followed by a washout period of 2 weeks and then week 6 to 10 SAD. |
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| SAD to LFD | Experimental | Week 1 to 4 participants will receive a SAD followed by a washout period of 2 weeks and then week 6 to 10 LFD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LFD | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ). | 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. | Baseline, 4 weeks |
| Change in quality of life as measured by the Food-Related Quality of Life (FR-QoL-29) Questionnaire. | 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. | Baseline, 4 weeks |
| Change in quality of life as measured by the Medical Outcomes Short Form-36 (SF-36) Questionnaire. | 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. | Baseline, 4 weeks |
| Change in the expression of inflammatory markers in the colon. | Change in the expression of interleukin (IL)-1β, IL-6 and Tumor Necrosis Factor alpha (TNFa) evaluated in pg/mL. | Baseline, 4 weeks |
| Change in the expression of cytokine in the colon. | Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluted in mg/L. | Baseline, 4 weeks |
| Change in intestinal microbiota | Change in relative abundance of the microbial communities evaluated as a percentage. | Baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ulcerative Colitis (UC) symptoms as measured by the partial Mayo score | The partial Mayo score ranges from 0 to 9 with a higher score indicating worsening UC symptoms. | Baseline, 4 weeks |
| Change in UC symptoms as measured by the Simple Clinical Colitis Activity Index (SCCAI) |
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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
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
Conditions/situations such as:
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
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| Name | Affiliation | Role |
|---|---|---|
| Maria Abreu, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32445952 | Derived | 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. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| SAD | Other | 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. |
|
SCCAI score ranges from 0 to 19 with a higher score indicating worsening UC symptoms. |
| Baseline, 4 weeks |
| Rate of adherence to fat intake | Adherence to fat intake is measured by the web-based daily food diary software Nutrihand. | Baseline, 4 weeks |
| Rate of adherence to diet items | Adherence to diet items is measured by the web-based daily food diary software Nutrihand. | Baseline, 4 weeks |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |