Fermented Food-Supplemented Diet in Ulcerative Colitis

NCT ID: NCT04401605

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2027-06-30

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.

Conditions

Inflammatory Bowel Diseases; Diet Modification; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fermented Food-supplemented Diet

Intervention Type: OTHER

Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.

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.

Group Type: PLACEBO_COMPARATOR

Regular Diet

Intervention Type: OTHER

No change in diet.

Interventions

Fermented Food-supplemented Diet

Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.

Intervention Type: OTHER

Regular Diet

No change in diet.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sidhartha Ranjit Sinha

Assistant Professor of Medicine (Gastroenterology and Hepatology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sidhartha Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Touran Fardeen

Role: CONTACT

tfardeen@stanford.edu

6507367311

Facility Contacts

Touran Fardeen

Role: primary

tfardeen@stanford.edu

Other Identifiers

IRB 55558

Identifier Type: -

Identifier Source: org_study_id