[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04401605":3,"trial-entities:NCT04401605":118,"trial-summary:NCT04401605":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":50,"sex":73,"minimum_age":74,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":75,"std_ages":92,"locations":95,"central_contacts":109,"overall_officials":112,"references":116,"see_also_links":117},"NCT04401605","IRB 55558","Fermented Food-Supplemented Diet in Ulcerative Colitis","Effects of a Fermented Food-Supplemented on Patients With Ulcerative Colitis","RECRUITING","2027-06","2026-02","2026-02-27","2020-09-14","Stanford University","OTHER",false,"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.",null,[19,20,21],"Inflammatory Bowel Diseases","Diet Modification","Ulcerative Colitis",[23,21,24,25,26],"IBD","UC","Diet","Fermented Food","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},21,"ESTIMATED",[35,40],{"type":14,"name":36,"description":37,"armGroupLabels":38},"Fermented Food-supplemented Diet","Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.",[39],"Fermented Food-Supplemented Diet",{"type":14,"name":41,"description":42,"armGroupLabels":43},"Regular Diet","No change in diet.",[44],"Regular Diet Control Arm",[46],{"measure":47,"description":48,"timeFrame":49},"Change in the clinical disease activity inflammatory marker fecal calprotectin","Change in fecal calprotectin","Baseline (Data Collection 1) versus Week 10 (Data Collection 2).",[51,54,58,61,64,67,70],{"measure":52,"description":53,"timeFrame":49},"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 \\\u003C=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).",{"measure":55,"description":56,"timeFrame":57},"Clinical remission as per partial Mayo score.","Clinical remission as per partial Mayo score is defined as a partial Mayo score \\\u003C 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).","Assessed at Week 10 (Data Collection 2).",{"measure":59,"description":60,"timeFrame":57},"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).",{"measure":62,"description":63,"timeFrame":57},"Patient global assessment","\"Do you believe you are in remission from your UC symptoms?\" (Yes\u002FNo)",{"measure":65,"description":66,"timeFrame":49},"Effect of Fermented Food-Supplemented Diet on patient quality of life","Change in Short Inflammatory Bowel Disease questionnaire (SIBDQ) score. The SIBDQ is a quality of life score in UC patients. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).",{"measure":68,"description":69,"timeFrame":49},"Changes in cytokines\u002Fchemokines and immune cell profiles","Cytokines\u002Fchemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, α4β7, CCR1, and CCR9) and immune cell profiles.",{"measure":71,"description":72,"timeFrame":49},"Changes in gut microbiome profiles","Gut microbiome profiles","ALL","18 Years",{"inclusion":76,"exclusion":82,"raw_text":91},[77,78,79,80,81],"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",[83,84,85,86,87,88,89,90],"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 \\\u003C 40%)","History of relevant intestinal surgery such as total or hemi-colectomy, proctocolectomy, stoma.","Inclusion Criteria:\n\n* Written informed consent\n* Male or female subjects, ≥18 years of age\n* Confirmed diagnosis of UC\n* Symptomatic disease defined as partial Mayo Score 2 to 7 (inclusive)\n* Elevated fecal calprotectin\n\nExclusion Criteria:\n\n* Women who are pregnant, nursing or expect to be pregnant\n* Intolerance to fermented food\n* Individuals with a body mass index (BMI) lower than 18\n* Individuals diagnosed with a serious medical condition (unless approved in writing by a physician)\n* Individuals who have been severely weakened by a disease or medical procedure\n* Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician\n* Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \\\u003C 40%)\n* History of relevant intestinal surgery such as total or hemi-colectomy, proctocolectomy, stoma.\n\nComplications of disease such as extraintestinal manifestations (EIMs) are not automatically considered exclusion criteria. Appropriate medical treatment for UC and\u002For EIMs will not be withheld.",[93,94],"ADULT","OLDER_ADULT",[96],{"facility":13,"status":8,"city":97,"state":98,"zip":99,"country":100,"contacts":101,"geoPoint":106},"Palo Alto","California","94305","United States",[102],{"name":103,"role":104,"email":105},"Touran Fardeen","CONTACT","tfardeen@stanford.edu",{"lat":107,"lon":108},37.44188,-122.14302,[110],{"name":103,"role":104,"phone":111,"email":105},"6507367311",[113],{"name":114,"affiliation":13,"role":115},"Sidhartha Sinha, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":119,"biomarkers":120},[21],[],{"nct_id":4,"found":122,"summary":123,"prompt_version":133},true,{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This interventional study plans to enroll 21 participants to compare a fermented food-supplemented diet with a regular diet.","completed","Fermented Food-Supplemented Diet for Ulcerative Colitis","This study is looking at how a diet supplemented with fermented foods, like kimchi, sauerkraut, yogurt, and kefir, affects inflammation and quality of life in people with mild to moderate Ulcerative Colitis (UC). Researchers want to understand if these foods can help reduce inflammation in the gut. You might be able to join if you are at least 18 years old, have a confirmed diagnosis of UC with active symptoms, and have elevated fecal calprotectin (a marker of inflammation). The study aims to see if there's a change in this inflammation marker after 10 weeks on the special diet compared to a regular diet. The current status of this study is unclear, and it plans to enroll 21 participants.","Participants are followed for 10 weeks after starting the diet.",119,"Participants will have their fecal calprotectin measured at the start of the study and again at Week 10.","Not stated in the trial record.",[41],"v2"]