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Fermented Food-Supplemented Diet in Ulcerative Colitis

Primary Purpose

Inflammatory Bowel Diseases, Diet Modification, Ulcerative Colitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fermented Food-supplemented Diet
Regular Diet
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring IBD, Ulcerative Colitis, UC, Diet, Fermented Food

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fermented Food-Supplemented Diet

Regular Diet Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in the clinical disease activity inflammatory marker fecal calprotectin
Change in fecal calprotectin

Secondary Outcome Measures

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).
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).
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).
Patient global assessment
"Do you believe you are in remission from your UC symptoms?" (Yes/No)
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).
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.
Changes in gut microbiome profiles
Gut microbiome profiles

Full Information

First Posted
May 20, 2020
Last Updated
May 16, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04401605
Brief Title
Fermented Food-Supplemented Diet in Ulcerative Colitis
Official Title
Effects of a Fermented Food-Supplemented on Patients With Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Diet Modification, Ulcerative Colitis
Keywords
IBD, Ulcerative Colitis, UC, Diet, Fermented Food

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fermented Food-Supplemented Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular Diet Control Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fermented Food-supplemented Diet
Intervention Description
Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.
Intervention Type
Other
Intervention Name(s)
Regular Diet
Intervention Description
No change in diet.
Primary Outcome Measure Information:
Title
Change in the clinical disease activity inflammatory marker fecal calprotectin
Description
Change in fecal calprotectin
Time Frame
Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Secondary Outcome Measure Information:
Title
Clinical response as per partial Mayo score.
Description
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).
Time Frame
Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Title
Clinical remission as per partial Mayo score.
Description
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).
Time Frame
Assessed at Week 10 (Data Collection 2).
Title
Symptomatic remission as per Patient Reported Outcome (PRO2) score
Description
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).
Time Frame
Assessed at Week 10 (Data Collection 2).
Title
Patient global assessment
Description
"Do you believe you are in remission from your UC symptoms?" (Yes/No)
Time Frame
Assessed at Week 10 (Data Collection 2).
Title
Effect of Fermented Food-Supplemented Diet on patient quality of life
Description
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).
Time Frame
Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Title
Changes in cytokines/chemokines and immune cell profiles
Description
Cytokines/chemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, α4β7, CCR1, and CCR9) and immune cell profiles.
Time Frame
Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Title
Changes in gut microbiome profiles
Description
Gut microbiome profiles
Time Frame
Baseline (Data Collection 1) versus Week 10 (Data Collection 2).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Touran Fardeen
Phone
6507367311
Email
tfardeen@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidhartha Sinha, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Touran Fardeen
Email
tfardeen@stanford.edu

12. IPD Sharing Statement

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Fermented Food-Supplemented Diet in Ulcerative Colitis

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