[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07613645":3,"trial-entities:NCT07613645":116,"trial-summary:NCT07613645":120},{"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":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":46,"secondary_outcomes":51,"sex":67,"minimum_age":68,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":69,"std_ages":90,"locations":93,"central_contacts":110,"overall_officials":112,"references":114,"see_also_links":115},"NCT07613645","HUM00284257","Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)","Diet for Prevention of Recurrent C. Difficile Infection","RECRUITING","2028-06","2026-07","2026-07-08","2026-06-05","University of Michigan","OTHER",false,"This study aims to evaluate the impact of diet on the gut microbiome in adults with Clostridioides difficile infection (CDI). Eligible participants will be randomized and receive meals plus different types of health counseling. Counseling visits will be by phone or online videoconference (e.g. Zoom). Meals will be provided for two weeks and then participants will be asked to continue similar meals for 6 more weeks.\n\nParticipants will provide responses to questionnaires and multiple stool samples over the course of the study. The goal is to understand how different health factors might impact the risk of becoming infected again with C. difficile in the future.\n\nOf note, this study will conceal the intervention details (type of diets) so that the control group does not increase their intake with the particular diet during the study. Participants in the control arm will be unblinded at the end of the study during a debrief with a member of the study team. At that time participants will be informed of diet being tested.",null,[19],"Clostridioides Difficile Infection",[21,22,23,24],"Diet","Health counseling","Surveys","Stool samples","INTERVENTIONAL","PREVENTION",[28],"NA",{"count":30,"type":31},20,"ESTIMATED",[33,38,42],{"type":14,"name":34,"description":35,"armGroupLabels":36},"Health counseling sessions","Participant will have two health counseling visits with a member of the study team between weeks 2-8.",[37],"Diet (control diet per protocol) plus health counseling",{"type":14,"name":39,"description":40,"armGroupLabels":41},"Diet (control diet)","Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.",[37],{"type":14,"name":43,"description":40,"armGroupLabels":44},"Diet (experimental diet)",[45],"Experimental Diet plus health counseling",[47],{"measure":48,"description":49,"timeFrame":50},"Change from baseline to week 2 in alpha-diversity of fecal microbiome by 16S rRNA sequencing","Change from baseline to week 2 (post feeding period) in alpha-diversity of fecal microbiome by 16S rRNA sequencing using Shannon index.","Baseline, 2 weeks (post feeding period)",[52,56,59,63],{"measure":53,"description":54,"timeFrame":55},"Change from baseline to week 8 in microbiome alpha-diversity (Shannon Index via 16S rRNA)","Measured by Shannon Index via 16S rRNA.","baseline to week 8",{"measure":57,"description":58,"timeFrame":55},"Incidence of recurrent CDI","Laboratory-confirmed symptomatic infection requiring treatment.",{"measure":60,"description":61,"timeFrame":62},"Change in CDI-related Quality of Life (QOL) baseline to Week 8","Patient-reported health-related quality of life assessed using the Clostridioides difficile Quality of Life Survey (Cdiff32) total score (range 0-100; higher scores indicate better quality of life).","Baseline to Week 8",{"measure":64,"description":65,"timeFrame":66},"Tolerability of diet based on the mean percent of meals consumed during the first 2 weeks","This is during the 2-weeks of receiving provided meals.","2 weeks (during the provided meal period)","ALL","18 Years",{"inclusion":70,"exclusion":77,"raw_text":89},[71,72,73,74,75,76],"Provision of signed and dated informed consent form","Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study","Non-recurrent non-fulminant CDI (laboratory-confirmed C. difficile infection without prior C. difficile infection within 3 months and no shock, hypotension, ileus, or megacolon)","Currently receiving treatment or with plan to initiate treatment for CDI","CDI treatment with standard regimen (fidaxomicin 200milligrams (mg) by mouth (PO) twice a day x 10-14 days or vancomycin 125mg PO 4 x a day (QID) x 10-14 days)","No prior advanced therapy for C. difficile (i.e. prolonged antibiotic therapy, bezlotoxumab, fecal transplant, other microbial therapy)",[78,79,80,81,82,83,84,85,86,87,88],"Chemotherapy, immunotherapy, or transplant within 12 months","Colon not in continuity (i.e. status post total colectomy or with current ileostomy)","Medical comorbidities requiring specific fluid, sodium, or protein intake level outside range of prepared diet options","Baseline diet with \\> 11grams fiber\u002F1000 kilocalories","Low sodium diet, vegan diet, gluten-free diet, Kosher diet or any other diet not able to be accommodated by the metabolic kitchen","Allergies, food preferences, or other restrictions not able to be accommodated by the metabolic (note: lactose intolerance will not impact eligibility)","Unwilling to stop probiotic supplements during the study period","Current antibiotic therapy that will continue after CDI treatment has finished","Hospitalized or in skilled nursing facility at time of CDI treatment conclusion","Pregnancy or breast-feeding","Unable to provide a stool sample of appropriate quality for further analysis (i.e. low volume, adulterated, delayed return, etc.)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n* Non-recurrent non-fulminant CDI (laboratory-confirmed C. difficile infection without prior C. difficile infection within 3 months and no shock, hypotension, ileus, or megacolon)\n* Currently receiving treatment or with plan to initiate treatment for CDI\n* CDI treatment with standard regimen (fidaxomicin 200milligrams (mg) by mouth (PO) twice a day x 10-14 days or vancomycin 125mg PO 4 x a day (QID) x 10-14 days)\n* No prior advanced therapy for C. difficile (i.e. prolonged antibiotic therapy, bezlotoxumab, fecal transplant, other microbial therapy)\n\nExclusion Criteria:\n\n* Chemotherapy, immunotherapy, or transplant within 12 months\n* Colon not in continuity (i.e. status post total colectomy or with current ileostomy)\n* Medical comorbidities requiring specific fluid, sodium, or protein intake level outside range of prepared diet options\n* Baseline diet with \\> 11grams fiber\u002F1000 kilocalories\n* Low sodium diet, vegan diet, gluten-free diet, Kosher diet or any other diet not able to be accommodated by the metabolic kitchen\n* Allergies, food preferences, or other restrictions not able to be accommodated by the metabolic (note: lactose intolerance will not impact eligibility)\n* Unwilling to stop probiotic supplements during the study period\n* Current antibiotic therapy that will continue after CDI treatment has finished\n* Hospitalized or in skilled nursing facility at time of CDI treatment conclusion\n* Pregnancy or breast-feeding\n* Unable to provide a stool sample of appropriate quality for further analysis (i.e. low volume, adulterated, delayed return, etc.)",[91,92],"ADULT","OLDER_ADULT",[94],{"facility":13,"status":8,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":107},"Ann Arbor","Michigan","48109","United States",[100,105],{"name":101,"role":102,"phone":103,"email":104},"Kira Newman, MD, PhD","CONTACT","734-615-4628","kinewman@med.umich.edu",{"name":101,"role":106},"PRINCIPAL_INVESTIGATOR",{"lat":108,"lon":109},42.27756,-83.74088,[111],{"name":101,"role":102,"phone":103,"email":104},[113],{"name":101,"affiliation":13,"role":106},[],[],{"nct_id":4,"conditions":117,"biomarkers":119},[118],"Clostridium difficile Infection",[],{"nct_id":4,"found":121,"summary":122,"prompt_version":132},true,{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is an interventional study that will randomly assign 20 participants to receive either a control diet or an experimental diet, along with health counseling.","completed","Diet and Recurrent Clostridioides Difficile Infection (CDI) Study","This study is looking at how different diets affect the gut microbiome (the collection of bacteria in your intestines) in adults who have had a Clostridioides difficile infection (CDI). If you join, you'll be randomly assigned to receive either a 'control diet' or an 'experimental diet'. For the first two weeks, all your meals will be provided, and then you'll be asked to follow a similar diet for six more weeks. You'll also have two health counseling sessions by phone or video call. Researchers will collect questionnaires and stool samples to understand if diet can help prevent future C. difficile infections. The study plans to enroll 20 participants and is currently unclear on its recruitment status.","The primary endpoint is measured at 2 weeks (post feeding period), but participants are asked to follow a diet for 6 weeks.",116,"You will have two health counseling visits, receive prepared meals for two weeks, and then follow a similar diet for six more weeks. You will also provide responses to questionnaires and multiple stool samples.","Not stated in the trial record.",[34],"v2"]