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Fermented Food-Supplemented Diet in Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT04401605
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : May 4, 2022
Sponsor:
Information provided by (Responsible Party):
Sidhartha Ranjit Sinha, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Diet Modification Ulcerative Colitis Other: Fermented Food-supplemented Diet Other: Regular Diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Fermented Food-Supplemented on Patients With Ulcerative Colitis
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Fermented Food-supplemented Diet
Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.
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.
 Other: Regular Diet
No change in diet.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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)

  5. 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).

  6. 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.

  7. Changes in gut microbiome profiles [ Time Frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2). ]
    Gut microbiome profiles


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401605


Contacts
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Contact: Touran Fardeen 6507367311 tfardeen@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Touran Fardeen       tfardeen@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Sidhartha Sinha, MD Stanford University
More Information
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Responsible Party: Sidhartha Ranjit Sinha, Assistant Professor of Medicine (Gastroenterology and Hepatology), Stanford University
ClinicalTrials.gov Identifier: NCT04401605    
Other Study ID Numbers: IRB 55558
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidhartha Ranjit Sinha, Stanford University:
IBD
Ulcerative Colitis
UC
Diet
Fermented Food
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes