Fermented Food-Supplemented Diet in Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fermented Food-supplemented Diet, Regular Diet.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases, Diet Modification, Ulcerative Colitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of a Fermented Food-Supplemented on Patients With Ulcerative Colitis
Overview
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
- Other Fermented Food-supplemented Diet
Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more. - Other Regular Diet
No change in diet.
Primary outcome measures
- Change in the clinical disease activity inflammatory marker fecal calprotectin [Time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).]
Secondary outcome measures (7)
- Clinical response as per partial Mayo score. [Time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).]
- Clinical remission as per partial Mayo score. [Time frame: Assessed at Week 10 (Data Collection 2).]
- Symptomatic remission as per Patient Reported Outcome (PRO2) score [Time frame: Assessed at Week 10 (Data Collection 2).]
- Patient global assessment [Time frame: Assessed at Week 10 (Data Collection 2).]
- Effect of Fermented Food-Supplemented Diet on patient quality of life [Time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).]
- Changes in cytokines/chemokines and immune cell profiles [Time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).]
- Changes in gut microbiome profiles [Time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Palo Alto
Identifiers
NCT: NCT04401605 · IRB 55558