Fermented Food-Supplemented Diet in Ulcerative Colitis

Stanford University

Status: Enrolling

Conditions: Ulcerative Colitis; Diet Modification; Inflammatory Bowel Diseases

Treatments: Other: Fermented Food-supplemented Diet; Other: Regular Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04401605

IRB 55558

Details and patient eligibility

About

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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups, including a placebo group

Fermented Food-Supplemented Diet

Experimental group

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.

Treatment:

Other: Fermented Food-supplemented Diet

Regular Diet Control Arm

Placebo Comparator group

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.

Treatment:

Other: Regular Diet