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Fermented Food-Supplemented Diet in Ulcerative Colitis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding fermented foods to the diet affects inflammation and quality of life. It is for adults with mild to moderate ulcerative colitis (UC), a disease that causes inflammation in the large intestine.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Give written consent to join the study.
  • Be age 18 or older.
  • Have a confirmed diagnosis of UC.
  • Have UC symptoms with a partial Mayo score of 2 to 7, a measure of disease activity.
  • Have high levels of calprotectin in stool, a sign of inflammation in the intestine.

Who can't join

  • Be pregnant, breastfeeding, or expecting to become pregnant.
  • Be unable to tolerate fermented foods.
  • Have a body mass index (BMI), a measure of weight compared with height, below 18.
  • Have a serious medical condition, unless a doctor gives written approval.
  • Be severely weakened by a disease or medical procedure.
  • Have heart or blood vessel disease worse than mild to moderate, or life-threatening cancer, unless a doctor approves.
  • Have a history of severe heart disease, especially poorly controlled heart failure rated NYHA class 2 or higher, or a heart pumping measure (LVEF) below 40%.
  • Have had certain bowel surgeries, such as removal of part or all of the colon, removal of the colon and rectum, or creation of a stoma (an opening in the belly for waste).

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

CA