Fermented Food-Supplemented Diet in Ulcerative Colitis

Study Overview
=================
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.

Official Title
-----------------
Effects of a Fermented Food-Supplemented on Patients With Ulcerative Colitis

Conditions
-----------------
Inflammatory Bowel Diseases, Diet Modification, Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: Fermented Food-supplemented Diet
* Other: Regular Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
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 exclusion criteria. Appropriate medical treatment for UC and/or EIMs will not be withheld.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermented Food-Supplemented Diet<br>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. | Other: Fermented Food-supplemented Diet<br>* Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.<br>|
| Placebo Comparator: Regular Diet Control Arm<br>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. | Other: Regular Diet<br>* No change in diet.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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). | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD, Ulcerative Colitis, UC, Diet, Fermented Food