Fermented Food-Supplemented Diet in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Effects of a Fermented Food-Supplemented on Patients With Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04401605
• Other study ID #: IRB 55558
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: Stanford University
• Contact: Touran Fardeen
• Phone: 6507367311
• Email: tfardeen[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Fermented food have been shown to positively influence inflammatory cytokines and intestinal microbial diversity in healthy volunteers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Diet Modification
• Inflammatory Bowel Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Fermented Food-supplemented Diet
Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.
• Regular Diet
No change in diet.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the clinical disease activity inflammatory marker fecal calprotectin	Change in fecal calprotectin	Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Secondary	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).	Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Secondary	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).	Assessed at Week 10 (Data Collection 2).
Secondary	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).	Assessed at Week 10 (Data Collection 2).
Secondary	Patient global assessment	"Do you believe you are in remission from your UC symptoms?" (Yes/No)	Assessed at Week 10 (Data Collection 2).
Secondary	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).	Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Secondary	Changes in cytokines/chemokines and immune cell profiles	Cytokines/chemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, a4ß7, CCR1, and CCR9) and immune cell profiles.	Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Secondary	Changes in gut microbiome profiles	Gut microbiome profiles	Baseline (Data Collection 1) versus Week 10 (Data Collection 2).