[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fecal-microbiota-therapy-fmt\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fecal-microbiota-therapy-fmt":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100599391","phase-2-faecal-autologous-capsule-transplantation-for-type-1-diabetes-mellitus-100599391",false,"NCT07083882","Faecal Autologous Capsule Transplantation for Type 1 Diabetes Mellitus","FACT-T1D","Inclusion Criteria:\n\n1. Male or female recently diagnosed (\\\u003C100 days) with type 1 diabetes mellitus.\n2. Age:18-45 years\n3. BMI: 18-30 kg\u002Fm2\n4. Remaining residual beta cell function: detectable plasma C-peptide or urinary C-peptide at inclusion of the study.\n\nExclusion Criteria:\n\n1. Major systemic illness\n2. (Expected) prolonged comprised immunity (e.g. due to recent cytotoxic chemotherapy or human immunodeficiency virus(HIV) infection with a CD4 count \\\u003C 240\u002Fmm3).\n3. History of a severe disease of the digestive tract, such as celiac disease, chronic diarrhoea (≥3 stools\u002Fday for \\>4 weeks), chronic obstipation (\\\u003C2 defecations\u002Fweek for \\>3 months) or Inflammatory Bowel Disease (IBD).\n4. Illicit drug use (e.g. MDMA\u002Famphetamine\u002Fcocaine\u002Fheroin\u002FGHB) in the past three months or use during the study period.\n5. Use of \\>21 units of alcohol per week on average in the past three months.\n6. Pregnancy or breast feeding.\n7. Inability to provide informed consent.","ALL","18 Years","45 Years",{"count":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","SUMMARY\n\nRationale:\n\nThe(small) intestinal microbiota composition has been implicated to play an important role in (human) metabolism, as well as autoimmune diseases such as type 1 diabetes mellitus. Faecal microbiota transplantation (FMT) has been shown to significantly alter the microbiota composition, without any serious side-effects. It was recently demonstrated that multiple infusions of own faeces(autologous) preserved residual beta cell function up to one year after start of the FMT. In a proof-of-principle study it was found that encapsulated autologous FMT provides a safe and feasible option for prolonged treatment on a daily basis, which might stabilize the beta-cell destruction. These exciting findings are potentially transformative for clinical practice and deserve replication in a larger placebo-controlled trial.\n\nObjective: confirm the efficacy and feasibility of daily ingested encapsulated freeze-dried autologous (own)faecal matter on the preservation of residual beta cell function as assessed by C-peptide release upon amixed meal test (MMT) in recently diagnosed type 1 diabetes mellitus (T1D).\n\nStudy design: double-blind placebo-controlled study Study population: n=110, recently diagnosed (\\\u003C100 days of diagnosis) patients with T1D, aged 18-45 years, BMI 18-30 kg\u002Fm2, male\u002Ffemale.\n\nIntervention: After inclusion and randomisation individuals will receive for 6 months either placebo or freeze-dried autologous encapsulated FMT in a 1:2 ratio. Subsequently, participants with be followed for 6 months whether beta cell preservation was durable after cessation of treatment.\n\nMain study parameters\u002Fendpoints: The primary endpoint is long-term preservation of beta cell insulin secretion capacity as assessed by stimulated C-peptide AUC0-120minresponse upon MMT (at0, 6 and 12months).The secondary endpoint pertains to changes in post-meal urinary C-peptide levels, plasma biochemistry (HbA1c levels),glucose time-in-range and subsequentexogenous insulin dose use at 0, 6 and 12months.\n\nNature and extent of the burden and risks associated with participation,benefit and group relatedness: This study is considered a low-risk study, 3MMTs will be performed, for which 70 ml of blood samples will be drawn each visit. As of today, no severe adverse events as result of FMT have been reported in this centre and in the ENCAPSULATE trial investigating the feasibility and safety of this approach participants only reported some minor and transient constipation. In addition, the use of autologous faeces comes with a lower(absent)risk for transmitting any unknown pathogens compared to an allogenic FMT. As there currently is no widely applied therapy to preserve beta cell function in type 1 diabetes, encapsulated autologous FMT can have a potential benefit for the participants.",[27,28,29],"Type 1 Diabetes Mellitis","Type 1 Diabetes (T1D)","Fecal Microbiota Therapy (FMT)",[31,32,33],"microbiome","type 1 diabetes","microbiota transplant","RECRUITING","2025-07-22",{"date":37,"type":38},"2025-07-24","ACTUAL",{"date":40,"type":21},"2025-09",{"date":42,"type":21},"2029-09",{"name":44,"class":45},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100588980","phase-2-a-flexible-clinical-trial-to-test-if-freeze-dried-fecal-microbiota-therapy-helps-treat-diarrhea-predominant-irritable-bowel-syndrome-or-prevent-recurring-c-difficile-infections-100588980","NCT06948461","A Flexible Clinical Trial to Test if Freeze-dried Fecal Microbiota Therapy Helps Treat Diarrhea-predominant Irritable Bowel Syndrome or Prevent Recurring C. Difficile Infections.","An Adaptive Basket Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Therapy in Management of Irritable Bowel Syndrome-diarrhea Predominant or Prevention of Recurrent Clostridioides Difficile Infection","ORAL-LYO-FMT","Inclusion Criteria:\n\n* 19 years of age and older\n* Able to provide informed consent\n* Must have at least one of the 3 following conditions:\n\n  1. Irritable bowel syndrome with diarrhea- predominant (IBS-D) as reported by patients of type 6 or 7 in Bristol stool chart and Rome IV diagnostic criteria:\n\n     1. Recurrent abdominal pain\u002Fdiscomfort\\*\\* at least 3 days\u002Fmonth in last 3 months associated with ≥2 of the following:\n     2. Symptom improvement with defecation;\n     3. Onset associated with change in stool frequency;\n     4. Onset associated with change in stool formation (with this last criterion fulfilled for last 3 months with symptom onset \\> 6 months prior to diagnosis\n  2. Primary or 1 episode recurrent Clostridioides difficile infection which is actively treated with CDI antibiotic (oral vancomycin, oral metronidazole or fidaxomicin) and clinically responding to treatment based on physician assessment at the time of recruitment.\n  3. 2 or more episodes of recurrent Clostridioides difficile infection, which is actively treated with CDI antibiotic (oral vancomycin, oral metronidazole or fidaxomicin) and clinically responding to treatment based on physician assessment at the time of recruitment.\n\nExclusion Criteria:\n\n1. Planned or actively taking other investigational product\n2. Unable to tolerate FMT or take oral medications.\n3. Requiring systemic antibiotic therapy at the time of FMT\n4. Actively taking probiotics \\[Consumption of yogurt is permitted\\]\n5. Severe allergy to any food and\u002For medications\n6. Major open abdominal surgery within the past 60 days\n7. Receipt of chemotherapy or radiation within 8 weeks of screening.\n8. Active small bowel obstruction.\n9. Those who are pregnant or plan to be pregnant within 3 months of the study. This will be determined on history alone at time of study entry and subsequent follow up.\n10. Those who are breastfeeding or plan to breast feed during the trial\n11. Not expected to survive beyond 30 days.\n12. Any current or previous medical or psychosocial condition or behaviours which in the opinion of the investigator may pose risk to the recipients or the study team\n\nExclusion Criteria:\n\n\\-","19 Years","120 Years",{"count":58,"type":21},63,[24],"The goal of this clinical trial is to learn if oral lyophilized fecal microbiota therapy (ORAL-LYO-FMT) helps treat diarrhea-predominant irritable bowel syndrome (IBS-D) and prevent the recurrence of Clostridioides difficile infection (rCDI). The main questions it aims to answer are:\n\n* Does ORAL-LYO-FMT reduce IBS symptoms?\n* Does it prevent rCDI after treatment?\n* What side effects or safety concerns might occur? Researchers will compare ORAL-LYO-FMT to a placebo (a look-alike capsule with no active treatment) to see how well it works.\n\nParticipants will:\n\n* Be randomly assigned to take ORAL-LYO-FMT or placebo for up to 7 weeks\n* Take capsules three times per week (Monday, Wednesday, Friday)\n* Complete health questionnaires and have follow-up visits by phone or in person for up to 6 months The trial also looks at changes in quality of life, mood, and new or ongoing medical conditions over time.",[62,63,29,64,65],"Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D)","Recurrent Clostridioides Difficile Infection (rCDI)","Irritable Bowel Syndrome (IBS)","Clostridioides Difficile Infection",[67,68,69,70,71,72,73,74],"IBS","Irritable bowel syndrome","rCDI","Fecal Microbiota Therapy","FMT","Gut Health","CDI","Clostridioides difficile infection, Recurrent","NOT_YET_RECRUITING","2025-04-21",{"date":78,"type":38},"2025-04-29",{"date":80,"type":21},"2025-09-01",{"date":82,"type":21},"2026-12",{"name":84,"class":85},"PharmaPlanter Technologies Inc","NETWORK"]