Fermented Food-Supplemented Diet in Ulcerative Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Fermented Food-supplemented Diet
Other interventionFermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.
Regular Diet
Other interventionNo change in diet.
Treatment groups
21 Participants
are divided into 2 treatment groupsGroup A: Fermented Food-Supplemented DietExperimental treatment 1 intervention
Group B: Regular Diet Control ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in the clinical disease activity inflammatory marker fecal calprotectin
Change in fecal calprotectin
Time frame
Baseline (Data Collection 1) versus Week 10 (Data Collection 2).Secondary outcomes
1
Clinical response as per partial Mayo score.
Clinical response as per partial Mayo score is defined as a decrease from baseline in the partial Mayo Score of \>=2 points and either a rectal bleeding subscore of \<=1 or a decrease in the rectal bleeding subscore of \>=1 point (assessed at Data Collection 2). The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy. Each subscore is graded from 0 to 3 (3 being the worst situation and 0 the best) and the partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).
Time frame
Baseline (Data Collection 1) versus Week 10 (Data Collection 2).2
Clinical remission as per partial Mayo score.
Clinical remission as per partial Mayo score is defined as a partial Mayo score \< 2 points and no individual subscale score \>1 point (assessed at Data Collection 2). The partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).
Time frame
Assessed at Week 10 (Data Collection 2).3
Symptomatic remission as per Patient Reported Outcome (PRO2) score
Symptomatic remission is defined as as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0 (assessed at Data Collection 2). The partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).
Time frame
Assessed at Week 10 (Data Collection 2).4
Patient global assessment
"Do you believe you are in remission from your UC symptoms?" (Yes/No)
Time frame
Assessed at Week 10 (Data Collection 2).Sponsors and contacts
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Source ClinicalTrials.gov