[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"synbiotics\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:synbiotics":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100634321","food-trial-evaluating-fecal-abundance-of-sbd111-with-once-daily-versus-twice-daily-administration-in-healthy-adults-100634321",false,"NCT07538167","Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults","An Open-Label, Randomized, Parallel-Arm Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults","Inclusion Criteria:• Provide written informed consent.\n\n* Stated availability throughout entire study period and willingness to fulfill all details of the protocol.\n* Age 35 years or older.\n* Be in general good health as determined by a screening evaluation within 30 days of the first administration of SBD111 medical foods.\n* Willing to comply with protocol and report on compliance and side effects during study period.\n* Body Mass Index between 18.5 and 40kg\u002Fm2.\n\nExclusion Criteria:\n\n* • Are currently taking probiotic or prebiotic supplements or have taken them in the past 30 days. If participant is willing to stop taking probiotic or prebiotic supplement for 30-days, they can be re-screened for eligibility and enrollment after consent.\n\n  * Unwilling to avoid probiotics\u002Fprebiotics supplements for the duration of the study.\n  * Known or suspected allergies to probiotics, maltodextrin, or berries.\n  * Received oral or parenteral antibiotics within 30 days of enrollment or prescribed antibiotics on the day of enrollment.\n  * Major surgery on the intestines or endoscopy within last 3 months.\n  * History of drug and\u002For alcohol abuse at the time of enrollment.\n  * Presence of any of the following based on participant reported health history:\n  * Clinically significant systems abnormalities based on screening questionnaire.\n  * Indwelling catheter or feeding tube.\n  * Febrile illness (oral temperature \\>37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline (first administration of study article).\n  * Active bowel leak, acute abdomen, colitis, or active GI disease or history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, or inflammatory bowel disease.\n  * History of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease.\n  * Underlying structural heart disease or previous history of endocarditis or valve replacement.\n  * Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy.\n  * History of Celiac disease.\n  * History of cancer.\n\n    a. Excluding non-melanoma skin cancers or cancer more than 10 years ago.\n  * History of autoimmune disease and taking any immunosuppressant drugs.\n  * Active tuberculosis.\n  * Pregnant, planning on becoming pregnant within the next 2 months, breastfeeding, positive urine pregnancy test within 24 hours of first administration of DMA.\n  * Participants may be excluded if, in the investigator's opinion, there is evidence of cognitive impairment or dementia which is sufficient to interfere with informed consent or adherence to the study protocol. Four questions will be asked during the informed consent process to confirm participant's understanding and ability to comply. (See section 8.3)\n  * Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.\n  * Bowel movement frequency less than one per 36-hour period.\n  * If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.",true,"ALL","35 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to determine whether a modified formulation and daily intake schedule of SBD111 results in similar levels of probiotic microbes in the gut compared with the currently used formulation. SBD111 is a food made of probiotic microbes (bacteria and yeast) and prebiotic dietary fibers (a form of fiber obtained from diet). SBD111 is a medical food used for the dietary management of postmenopausal bone loss.SBD111 was previously found to be safe and well tolerated in a human clinical safety study and a clinical efficacy study. Study participation will include a screening virtual visit, periodic remote questionnaires and check-in calls, and three at-home stool swab sample collections.\n\nEligible participants will be assigned to one of two SBD111 study groups evaluating different formulations and dosing schedules. Each day for a 28-day period, they will take (i) two capsules once daily or (ii) two capsules twice daily (morning and evening), depending on the study group assigned. Investigators will collect demographic information and will ask questions related to dietary intake, bowel habits, and health history. Upon enrollment into the study, participants will receive six at-home stool sample collection kits, two each for baseline, Week 1, and Week 4 analysis. Samples will be collected at home and mailed to a Sōlaria Biō for analysis of the bacterial community that lives in the intestine (the gut microbiome). During the study, participants will also be asked to complete brief questionnaires related to gastrointestinal symptoms, cognitive function, well-being, and sleep. On days 7 and 28 of the study, they will be asked to complete a brief adherence questionnaire and discuss any adverse (negative) events.\n\nAll participants will receive compensation in the form of gift cards for completing study procedures and returning stool samples. Participants will receive a $50.00 gift card after completing the Week 1 study procedures and after receipt of the mailed baseline and Day 7 stool swab samples. Participants will receive a $150.00 gift card after completing the Week 4 study procedures and after receipt of the mailed Week 4 stool swab sample.",[27,28,29,30,31],"Osteopenia","Osteoporosis","Menopause Related Conditions","Probiotic Intervention","Synbiotics",[33,34,35,27,28,36],"Probiotic","Synbiotic","Bone Loss","Fully Remote","NOT_YET_RECRUITING","2026-04-15",{"date":40,"type":41},"2026-04-20","ACTUAL",{"date":43,"type":21},"2026-04",{"date":45,"type":21},"2027-02",{"name":47,"class":48},"Solarea Bio, Inc","INDUSTRY",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":16,"sex":57,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100513529","synbiotics-in-patients-at-risk-for-preterm-birth-100513529","NCT05966649","Synbiotics in Patients at RIsk fOr Preterm Birth","Synbiotics in Patients at RIsk fOr Preterm Birth: a Multi-center Double-blind Randomized Placebo-controlled trIal","PRIORI","Inclusion Criteria:\n\n1. Signed written informed consent must be obtained before any study assessment is performed;\n2. 18 years of age or older;\n3. Singleton pregnancy;\n4. Pregnancy consultation between 8 and 10 weeks gestation.\n5. At least one of the following risk factors for spontaneous preterm birth:\n\n   * Prior spontaneous preterm birth, defined as delivery between 24 and 36 weeks following PPROM, preterm labor or cervical insufficiency\n   * PPROM ≤36 weeks in previous pregnancy\n   * Prior spontaneous second-trimester pregnancy loss, defined as PPROM, preterm labor or cervical insufficiency with birth between 14 and 24 weeks.\n\nExclusion Criteria:\n\n1. Patients who are already using pro-, pre- or synbiotics and not willing to stop\n2. Multiple pregnancy\n3. Need for primary (type 1) cerclage\n4. Inflammatory bowel disease\n5. Known congenital uterine anomaly\n6. History of LLETZ conization","FEMALE","18 Years",{"count":60,"type":21},402,[24],"Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated.\n\nPrevious preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as 'high risk' for preterm birth.\n\nInfections ascending from the vagina may be an important cause of preterm delivery in certain cases. Some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. On the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation).\n\nSynbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy, while prebiotics are consumed by the bacteria. It is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora that may protect against infections. In this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. The investigators will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. The hypothesis is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal flora into a stable micro-environment.",[64,65,66,67,68,31],"Preterm Spontaneous Labor With Preterm Delivery","Preterm Birth","Microbial Colonization","Microbiome Dysbiosis","Vaginal Microbiome",[70,71,72,31],"Preterm birth","Vaginal microbiome","Probiotics","RECRUITING","2026-02-23",{"date":76,"type":41},"2026-02-27",{"date":78,"type":41},"2023-03-16",{"date":80,"type":21},"2029-06",{"name":82,"class":83},"Ziekenhuis Oost-Limburg","OTHER",9,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":16,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100584573","effect-of-probiotic-and-synbiotic-administration-on-nutritional-status-in-hemodialysis-patients-100584573","NCT06891105","Effect of Probiotic and Synbiotic Administration on Nutritional Status in Hemodialysis Patients","Effect of Probiotic and Synbiotic Administration on the Nutritional Status of Hemodialysis Patients. a Randomized Controlled Trial","ProSyn-HD","Inclusion Criteria:\n\n* Patients with End-Stage Renal Disease (ESRD) on regular hemodialysis (3 times per week).\n* Age 18 years or older.\n* Not prepared for kidney transplantation for more than 1 year.\n* Able and willing to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who are actively preparing for kidney transplantation.\n* Pregnant or breastfeeding women.\n* Patients with active malignancy or undergoing cancer treatment.\n* Patients with known structural gastrointestinal (GI) disease (e.g., inflammatory bowel disease, severe gastrointestinal motility disorders).\n* Patients who have severe infections or other severe conditions that might interfere with the study's assessments.\n* Patients with known allergies to probiotics or synbiotics.",{"count":94,"type":21},60,[24],"This study aims to investigate the impact of probiotics and synbiotics on the nutritional status of patients with end-stage kidney disease (ESRD) who are undergoing hemodialysis. ESRD patients often face challenges such as poor nutritional status, increased risk of infections, and imbalances in gut microbiota. These challenges are made worse by the frequent use of medications, dietary restrictions, and the hemodialysis process itself, which can disturb the gut's natural bacteria balance.\n\nProbiotics are live microorganisms that provide health benefits when taken in adequate amounts, while synbiotics are a combination of probiotics and prebiotics (substances that promote the growth of beneficial bacteria). The goal of this study is to explore whether supplementing ESRD patients with probiotics or synbiotics can improve their nutritional health, including aspects like body mass index (BMI), skin fold thickness, and protein metabolism.\n\nThe study will involve 60 patients from a hemodialysis center in Mansoura, Egypt. Patients will be randomly assigned to one of three groups: one group will receive probiotics, another will receive synbiotics, and the third group will act as a control (no treatment). The study will evaluate changes in nutritional markers and other health parameters before and after six months of supplementation.\n\nThis study hopes to provide insights into new, cost-effective interventions for improving the health of patients undergoing long-term dialysis treatment by addressing the question of whether these supplements can improve the nutritional status of hemodialysis patients.",[98,72,31,99],"Hemodialysis","Nutritional Status",[101,98,72,31,99,102],"End-Stage Renal Disease","Gut Microbiota","2025-03-18",{"date":105,"type":41},"2025-03-24",{"date":107,"type":21},"2025-04-15",{"date":109,"type":21},"2025-11-01",{"name":111,"class":83},"Mansoura University"]