RECRUITING

Fermented Food-Supplemented Diet in Ulcerative Colitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-09-14
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04401605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed consent
  2. * Male or female subjects, ≥18 years of age
  3. * Confirmed diagnosis of UC
  4. * Symptomatic disease defined as partial Mayo Score 2 to 7 (inclusive)
  5. * Elevated fecal calprotectin
  1. * Women who are pregnant, nursing or expect to be pregnant
  2. * Intolerance to fermented food
  3. * Individuals with a body mass index (BMI) lower than 18
  4. * Individuals diagnosed with a serious medical condition (unless approved in writing by a physician)
  5. * Individuals who have been severely weakened by a disease or medical procedure
  6. * Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician
  7. * Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \< 40%)
  8. * History of relevant intestinal surgery such as total or hemi-colectomy, proctocolectomy, stoma.

Contacts and Locations

Study Contact

Touran Fardeen
CONTACT
6507367311
tfardeen@stanford.edu

Principal Investigator

Sidhartha Sinha, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University
Palo Alto, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Sidhartha Sinha, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-14
Study Completion Date2027-06

Study Record Updates

Study Start Date2020-09-14
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • IBD
  • Ulcerative Colitis
  • UC
  • Diet
  • Fermented Food

Additional Relevant MeSH Terms

  • Inflammatory Bowel Diseases
  • Diet Modification
  • Ulcerative Colitis