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The purpose of this study is to see how a diet that supplements fermented foods effects inflammation and quality of life in patients with mild to moderate Ulcerative Colitis (UC). There is a paucity of research and an enormous need for better understanding of diet and intestinal inflammation. Fermented food have been shown to positively influence inflammatory cytokines and intestinal microbial diversity in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermented Food-Supplemented Diet | Experimental | Patients in this arm will supplement their regular diet by an increasing number of daily servings of fermented food over a period of 10 weeks. |
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| Regular Diet Control Arm | Placebo Comparator | Patients in this arm will continue their regular diet throughout the 10 weeks of study with a maximum of 1 serving of fermented foods per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented Food-supplemented Diet | Other | Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the clinical disease activity inflammatory marker fecal calprotectin | Change in fecal calprotectin | Baseline (Data Collection 1) versus Week 10 (Data Collection 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response as per partial Mayo score. | Clinical response as per partial Mayo score is defined as a decrease from baseline in the partial Mayo Score of >=2 points and either a rectal bleeding subscore of <=1 or a decrease in the rectal bleeding subscore of >=1 point (assessed at Data Collection 2). The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy. Each subscore is graded from 0 to 3 (3 being the worst situation and 0 the best) and the partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome). |
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Inclusion Criteria:
Exclusion Criteria:
Complications of disease such as extraintestinal manifestations (EIMs) are not automatically considered exclusion criteria. Appropriate medical treatment for UC and/or EIMs will not be withheld.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Touran Fardeen | Contact | 6507367311 | tfardeen@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sidhartha Sinha, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Regular Diet | Other | No change in diet. |
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| Baseline (Data Collection 1) versus Week 10 (Data Collection 2). |
| Clinical remission as per partial Mayo score. | Clinical remission as per partial Mayo score is defined as a partial Mayo score < 2 points and no individual subscale score >1 point (assessed at Data Collection 2). The partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome). | Assessed at Week 10 (Data Collection 2). |
| Symptomatic remission as per Patient Reported Outcome (PRO2) score | Symptomatic remission is defined as as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0 (assessed at Data Collection 2). The partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome). | Assessed at Week 10 (Data Collection 2). |
| Patient global assessment | "Do you believe you are in remission from your UC symptoms?" (Yes/No) | Assessed at Week 10 (Data Collection 2). |
| Effect of Fermented Food-Supplemented Diet on patient quality of life | Change in Short Inflammatory Bowel Disease questionnaire (SIBDQ) score. The SIBDQ is a quality of life score in UC patients. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best). | Baseline (Data Collection 1) versus Week 10 (Data Collection 2). |
| Changes in cytokines/chemokines and immune cell profiles | Cytokines/chemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, α4β7, CCR1, and CCR9) and immune cell profiles. | Baseline (Data Collection 1) versus Week 10 (Data Collection 2). |
| Changes in gut microbiome profiles | Gut microbiome profiles | Baseline (Data Collection 1) versus Week 10 (Data Collection 2). |
| D003092 | Colitis |
| D003108 | Colonic Diseases |