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Fermented Foods Diet for Ulcerative Colitis
N/A
Recruiting
Led By Sidhartha Sinha, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of UC
Symptomatic disease defined as partial Mayo Score 2 to 7 (inclusive)
Must not have
Women who are pregnant, nursing or expect to be pregnant
Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF < 40%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (data collection 1) versus week 10 (data collection 2).
Summary
This trial will test if a diet rich in fermented foods can help improve symptoms and quality of life in people with UC.
Who is the study for?
This trial is for men and women over 18 with mild to moderate Ulcerative Colitis (UC), confirmed by diagnosis. Participants must have symptoms, shown by a partial Mayo Score of 2-7, and elevated fecal calprotectin levels. They need to give written consent to join.
What is being tested?
The study aims to understand the impact of a diet supplemented with fermented foods on inflammation and life quality in UC patients compared to those on a regular diet. It explores how these foods might affect gut health and inflammatory responses.
What are the potential side effects?
While not explicitly listed, potential side effects may include changes in digestion or discomfort due to dietary adjustments. Fermented foods can sometimes cause bloating or gas as the body adapts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with ulcerative colitis.
Select...
My symptoms are moderate, based on a specific score.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently pregnant, nursing, or planning to become pregnant.
Select...
I do not have severe heart disease, such as heart failure worse than NYHA grade 1 or a left ventricular ejection fraction less than 40%.
Select...
I have had major surgery on my intestines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (data collection 1) versus week 10 (data collection 2).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (data collection 1) versus week 10 (data collection 2).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the clinical disease activity inflammatory marker fecal calprotectin
Secondary study objectives
Changes in cytokines/chemokines and immune cell profiles
Changes in gut microbiome profiles
Clinical remission as per partial Mayo score.
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fermented Food-Supplemented DietExperimental Treatment1 Intervention
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 II: Regular Diet Control ArmPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,469 Previous Clinical Trials
17,496,542 Total Patients Enrolled
Sidhartha Sinha, MDPrincipal InvestigatorStanford University
4 Previous Clinical Trials
184 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently pregnant, nursing, or planning to become pregnant.I am 18 years old or older.I have been diagnosed with ulcerative colitis.I do not have severe heart disease, such as heart failure worse than NYHA grade 1 or a left ventricular ejection fraction less than 40%.My symptoms are moderate, based on a specific score.I am severely weakened by a disease or medical procedure.I have had major surgery on my intestines.
Research Study Groups:
This trial has the following groups:- Group 1: Fermented Food-Supplemented Diet
- Group 2: Regular Diet Control Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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