Fermented Food-Supplemented Diet in Ulcerative Colitis

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Diet Modification
• Interventions: Other: Fermented Food-supplemented Diet; Other: Regular Diet

• Registration Number: NCT04401605
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Study Start: 2020-09-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2026-06-30
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fermented Food-Supplemented Diet	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.
Regular Diet Control Arm	Regular Diet	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.

Primary Outcome Measures

Name	Time	Method
Change in the clinical disease activity inflammatory marker fecal calprotectin	Baseline (Data Collection 1) versus Week 10 (Data Collection 2).	Change in fecal calprotectin

Secondary Outcome Measures

Name	Time	Method
Clinical remission as per partial Mayo score.	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).
Clinical response as per partial Mayo score.	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).
Patient global assessment	Assessed at Week 10 (Data Collection 2).	"Do you believe you are in remission from your UC symptoms?" (Yes/No)
Changes in cytokines/chemokines and immune cell profiles	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.
Symptomatic remission as per Patient Reported Outcome (PRO2) score	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).
Effect of Fermented Food-Supplemented Diet on patient quality of life	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).
Changes in gut microbiome profiles	Baseline (Data Collection 1) versus Week 10 (Data Collection 2).	Gut microbiome profiles

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States