Diet Modification, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Keywords
IBD, Ulcerative Colitis, UC, Diet, Fermented Food
Brief summary
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.
Interventions
OTHERFermented Food-supplemented Diet
Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.
OTHERRegular Diet
No change in diet.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Male or female subjects, ≥18 years of age * Confirmed diagnosis of UC * Symptomatic disease defined as partial Mayo Score 2 to 7 (inclusive) * Elevated fecal calprotectin
Exclusion criteria
* Women who are pregnant, nursing or expect to be pregnant * Intolerance to fermented food * Individuals with a body mass index (BMI) lower than 18 * Individuals diagnosed with a serious medical condition (unless approved in writing by a physician) * Individuals who have been severely weakened by a disease or medical procedure * Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician * Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \< 40%) * History of relevant intestinal surgery such as total or hemi-colectomy, proctocolectomy, stoma. Complications of disease such as extraintestinal manifestations (EIMs) are not automatically considered
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the clinical disease activity inflammatory marker fecal calprotectin | Baseline (Data Collection 1) versus Week 10 (Data Collection 2). | Change in fecal calprotectin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response as per partial Mayo score. | Baseline (Data Collection 1) versus Week 10 (Data Collection 2). | 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). |
| Clinical remission as per partial Mayo score. | Assessed at Week 10 (Data Collection 2). | 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). |
| Symptomatic remission as per Patient Reported Outcome (PRO2) score | Assessed at Week 10 (Data Collection 2). | 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). |
| Patient global assessment | Assessed at Week 10 (Data Collection 2). | "Do you believe you are in remission from your UC symptoms?" (Yes/No) |
| Effect of Fermented Food-Supplemented Diet on patient quality of life | Baseline (Data Collection 1) versus Week 10 (Data Collection 2). | 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). |
| Changes in cytokines/chemokines and immune cell profiles | Baseline (Data Collection 1) versus Week 10 (Data Collection 2). | Cytokines/chemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, α4β7, CCR1, and CCR9) and immune cell profiles. |
| Changes in gut microbiome profiles | Baseline (Data Collection 1) versus Week 10 (Data Collection 2). | Gut microbiome profiles |
Countries
United States
Contacts
CONTACTTouran Fardeen
PRINCIPAL_INVESTIGATORSidhartha Sinha, MD
Stanford University
Outcome results
None listed