Inflammatory Bowel DiseasesNCT04401605
Fermented Food-Supplemented Diet in Ulcerative Colitis
A study testing Fermented Food-supplemented Diet and Regular Diet in people with Inflammatory Bowel Diseases and Diet Modification, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Diet Modification, Ulcerative Colitis
- What is being tested?
- Fermented Food-supplemented Diet and Regular Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94305
Touran Fardeen, tfardeen@stanford.edu
About this study
Official title: Effects of a Fermented Food-Supplemented on Patients With Ulcerative Colitis
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.
- Being tested
- Fermented Food-supplemented Diet, Regular Diet
- Keywords
- IBD, Ulcerative Colitis, UC, Diet, Fermented Food
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented Food-supplemented DietOther
Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.
Regular DietOther
No change in diet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fermented Food-supplemented Diet |
| 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. Receives: Other: Regular Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the clinical disease activity inflammatory marker fecal calprotectin
Change in fecal calprotectin
Measured: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: Assessed at Week 10 (Data Collection 2).
Patient global assessment
"Do you believe you are in remission from your UC symptoms?" (Yes/No)
Measured: 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).
Measured: 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.
Measured: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Changes in gut microbiome profiles
Gut microbiome profiles
Measured: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start14 Sep 2020
- Primary completion30 Jun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidhartha Ranjit Sinha, Stanford University
- Investigators
- Sidhartha Sinha, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401605
- Sponsor's protocol ID
- IRB 55558
- Status last verified
- Feb 2026
- First submitted
- 20 May 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Fermented Food-Supplemented on Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04401605
- Acronym / sponsor ID
- IRB 55558
- Keywords
- IBD, Ulcerative Colitis, UC, Diet, Fermented Food
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented Food-Supplemented Diet | Experimental | Other: Fermented Food-supplemented DietPatients in this arm will supplement their regular diet by an increasing number of daily servings of fermented food over a period of 10 weeks. |
| Regular Diet Control Arm | Placebo comparator | Other: Regular DietPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented Food-supplemented DietFermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more. | Other | Fermented Food-Supplemented Diet |
| Regular DietNo change in diet. | Other | Regular Diet Control Arm |
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
7 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sidhartha Sinha, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented Food-supplemented Diet and Regular Diet in people with Inflammatory Bowel Diseases and Diet Modification, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Touran Fardeen (6507367311, tfardeen@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the clinical disease activity inflammatory marker fecal calprotectin (time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.