Fermented Food-Supplemented Diet in Ulcerative Colitis

Launched by STANFORD UNIVERSITY · May 20, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating how a diet that includes fermented foods can help reduce inflammation and improve the quality of life for people with mild to moderate Ulcerative Colitis (UC), a condition that causes inflammation in the intestines. Researchers believe that fermented foods, which contain beneficial bacteria, might have a positive effect on gut health, but there hasn't been enough research on this topic. The study is currently recruiting participants aged 18 and older who have been diagnosed with UC and are experiencing symptoms.

To participate, individuals need to provide written consent and have a confirmed diagnosis of UC with specific symptoms. However, certain people are not eligible, such as pregnant or nursing women, those who cannot tolerate fermented foods, and individuals with serious health conditions. Participants will get a chance to explore how changing their diet might help manage their UC symptoms. Overall, this trial aims to better understand the connection between diet and intestinal inflammation, which is an important area of research for improving care for patients with UC.

Gender

ALL

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.