Diet Modification · Inflammatory Bowel Diseases · Ulcerative Colitis
Fermented Food-Supplemented Diet Study for Adults With Ulcerative Colitis
This randomized study examines inflammation and quality of life in adults with mild to moderate ulcerative colitis who follow either a fermented food-supplemented diet or their regular diet for 10 weeks.
Registry title: Fermented Food-Supplemented Diet in Ulcerative Colitis
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- Fermented Food-supplemented Diet or Regular Diet
- Design
- Randomized
- Central study contact
- Touran Fardeen6507367311tfardeen@stanford.edu
- Sponsor
- Stanford University
Research question
How does adding fermented foods to the regular diet affect inflammation, ulcerative colitis symptoms, immune and gut microbiome measures, and quality of life over 10 weeks?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older.
- The study is looking for people with a confirmed diagnosis of ulcerative colitis.
- The study is looking for people with symptomatic disease, defined as a partial Mayo Score from 2 through 7.
- The study is looking for people with elevated fecal calprotectin, a stool marker of intestinal inflammation.
- The listed recruiting location is Stanford University in Palo Alto, California.
Participation overview
What participation may involve
Participants are randomly assigned either to add increasing daily servings of fermented foods to their regular diet or to continue their regular diet with no more than one fermented-food serving per day. What participation may involve: - Follow the assigned diet for 10 weeks. - Complete baseline and week-10 assessments of fecal calprotectin, ulcerative colitis symptoms, and quality of life. - Undergo baseline and week-10 assessment of cytokines, chemokines, immune-cell profiles, and gut microbiome profiles. The assigned diet period lasts 10 weeks.
Study interventions
What participants may receive or do
- Fermented Food-supplemented Diet: Participants assigned to this intervention supplement their regular diet with an increasing number of daily fermented-food servings for 10 weeks. Examples include kimchi, sauerkraut, yoghurt, and kefir.
- Regular Diet: Participants assigned to this control intervention continue their regular diet for 10 weeks, with no more than one serving of fermented food per day.
Study design
How the comparison works
This is an interventional, parallel-group study comparing a fermented food-supplemented diet with continuation of a regular diet. The estimated enrollment is 21 participants. Participants are assigned at random to one of the two diet groups; the registry does not report the allocation ratio. The study is open-label, meaning the registry reports no masking. The control group continues its regular diet for 10 weeks and is limited to a maximum of one fermented-food serving per day. The registry labels the regular-diet arm as a placebo comparator, but it describes no placebo or sham product; participants continue their regular diet.
Reported activities
Procedures and tests
- Fecal calprotectin is assessed at baseline and week 10 to measure change in an inflammatory marker.
- The partial Mayo Score is used to assess stool frequency, rectal bleeding, and the physician global assessment.
- The Patient Reported Outcome 2 (PRO2) score is used to assess stool frequency and rectal bleeding at week 10.
- Participants answer a yes-or-no question at week 10 about whether they believe their ulcerative colitis symptoms are in remission.
- The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is completed to assess quality of life at baseline and week 10.
- Cytokines, chemokines, and immune-cell profiles are assessed at baseline and week 10.
- Gut microbiome profiles are assessed at baseline and week 10.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must provide written informed consent.
- Participants must be age 18 or older.
- Participants must have a confirmed diagnosis of ulcerative colitis.
- Participants must have symptomatic disease with a partial Mayo Score from 2 through 7, inclusive.
- Participants must have elevated fecal calprotectin.
Possible reasons someone may not be able to join
- People who are pregnant, nursing, or expect to become pregnant are excluded.
- People who cannot tolerate fermented food are excluded.
- People with a body mass index below 18 are excluded.
- A serious medical condition is exclusionary unless a physician gives written approval.
- People severely weakened by a disease or medical procedure are excluded.
- More than mild-to-moderate cardiovascular disease or life-threatening cancer is exclusionary as determined by the person's physician, unless a physician approves participation.
- A history of severe cardiac disease is exclusionary, particularly uncompensated congestive heart failure of New York Heart Association grade 2 or higher or a left ventricular ejection fraction below 40%.
- A history of relevant intestinal surgery, such as total or half colectomy, proctocolectomy, or a stoma, is exclusionary.
Important unknowns
What the record does not make clear
- The registry identifies baseline and week-10 data collections but does not report the number, timing, format, or length of study visits.
- The study is randomized, but the allocation ratio and chance of assignment to each diet group are not reported. The control arm is labeled a placebo comparator even though no placebo or sham product is described.
- The criteria state that appropriate treatment for ulcerative colitis or extraintestinal manifestations will not be withheld, but permitted medications and requirements for stable doses are not specified.
- The registry does not report whether any medications must be stopped or washed out before enrollment.
- The registry does not explain how worsening ulcerative colitis symptoms would be treated during the study.
- The registry does not state that endoscopy is required; the described partial Mayo Score specifically omits endoscopy.
- The registry does not state who pays for fermented foods, research assessments, clinical care, or other study-related costs.
- The registry does not report whether participants are compensated.
- The registry does not report reimbursement or assistance for travel to the Palo Alto site.
- The registry lists one Stanford University location but does not say whether any study activities can be completed remotely.
Before contacting the site
Questions for the study team
- How many study visits are required, which are in person, and how long does each take?
- What is the chance of assignment to each diet group?
- Which ulcerative colitis medicines and treatments for extraintestinal manifestations can continue, and must doses remain stable?
- What happens if symptoms worsen or fecal calprotectin rises during the study?
- What samples are collected for fecal calprotectin, immune profiling, and gut microbiome analysis, and how often?
- Is any endoscopy required during screening or follow-up?
- Are fermented foods supplied, and which research or clinical costs might participants or insurance need to cover?
- Can any activities be completed remotely, and is travel or parking assistance available for visits in Palo Alto?
Before changing care
Questions for your gastroenterologist
- Would changing fermented-food intake be appropriate given my current ulcerative colitis activity, nutrition, and other medical conditions?
- Could my current ulcerative colitis medicines continue safely and effectively during this study, and should any doses remain stable?
- How stable is my disease now, and what signs would mean that dietary study participation should be reconsidered?
- What approved treatment and nutrition alternatives should I consider alongside learning about this study?
- How should my gastroenterology team and the Stanford research team coordinate laboratory results, symptom changes, and treatment decisions?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Stanford University
- Organization class
- Other
- Organization study ID
- IRB 55558
- Lead sponsor
- Stanford University
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Fermented Food-Supplemented Diet
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.
Interventions: Other: Fermented Food-supplemented Diet
Placebo Comparator
Regular Diet Control Arm
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.
Interventions: Other: Regular Diet
Interventions
Other
Fermented Food-supplemented Diet
Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.
Other
Regular Diet
No change in diet.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (5)
- Written informed consentRegistry-derived · unreviewed
- Male or female subjects, ≥18 years of ageRegistry-derived · unreviewed
- Confirmed diagnosis of UCRegistry-derived · unreviewed
- Symptomatic disease defined as partial Mayo Score 2 to 7 (inclusive)Registry-derived · unreviewed
- Elevated fecal calprotectinRegistry-derived · unreviewed
Exclusion criteria (9)
- Women who are pregnant, nursing or expect to be pregnantRegistry-derived · unreviewed
- Intolerance to fermented foodRegistry-derived · unreviewed
- Individuals with a body mass index (BMI) lower than 18Registry-derived · unreviewed
- Individuals diagnosed with a serious medical condition (unless approved in writing by a physician)Registry-derived · unreviewed
- Individuals who have been severely weakened by a disease or medical procedureRegistry-derived · unreviewed
- Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physicianRegistry-derived · unreviewed
- Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \< 40%)Registry-derived · unreviewed
- History of relevant intestinal surgery such as total or hemi-colectomy, proctocolectomy, stoma.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Change in the clinical disease activity inflammatory marker fecal calprotectin
Time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Change in fecal calprotectin
Secondary outcome
Clinical response as per partial Mayo score.
Time frame: 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).
Secondary outcome
Clinical remission as per partial Mayo score.
Time frame: 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).
Secondary outcome
Symptomatic remission as per Patient Reported Outcome (PRO2) score
Time frame: 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).
Secondary outcome
Patient global assessment
Time frame: Assessed at Week 10 (Data Collection 2).
"Do you believe you are in remission from your UC symptoms?" (Yes/No)
Secondary outcome
Effect of Fermented Food-Supplemented Diet on patient quality of life
Time frame: 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).
Secondary outcome
Changes in cytokines/chemokines and immune cell profiles
Time frame: 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.
Secondary outcome
Changes in gut microbiome profiles
Time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Gut microbiome profiles
Recruiting locations in the United States
Stanford University
RecruitingPalo Alto, California, 94305, United States
Touran Fardeentfardeen@stanford.edu
Central study contacts
Registry dates
- First posted
- May 26, 2020
- Primary completion
- Jun 30, 2026
- Overall completion
- Jun 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.