[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441119":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":35,"studyPopulation":28,"armGroups":36,"interventions":55,"overallOfficials":78,"centralContacts":83,"locations":88,"responsibleParty":106,"collaborators":109,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":28,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":28,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":28,"overallStatus":91,"whyStopped":28,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Assaf-Harofeh Medical Center","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"Microbiome Profiling","Using stool and buccal samples for microbiome composition analysis","1 month",{"measure":14,"description":15,"timeFrame":12},"Physical ability","will be measured by several tests: flexibility, Biodex, maximal oxygen uptake (VO2 max), high jumps, 30 seconds jumps, lactate measurement.",[17],{"measure":18,"description":19,"timeFrame":12},"Glycemic Responses","Performing continuous glucose monitor (CGM)",[21],{"measure":22,"description":23,"timeFrame":24},"D- lactate measurement","measuring D-Lactate threshold","18 days",{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":28,"timePerspective":28,"maskingInfo":30},"RANDOMIZED","PARALLEL",null,"BASIC_SCIENCE",{"masking":31,"maskingDescription":28,"whoMasked":32},"DOUBLE",[33,34],"PARTICIPANT","INVESTIGATOR","In this interventional study participants will be followed by researchers for up to 1 month. During all days of the study participants will be connected to a continuous glucose monitor (CGM). During the study, participants will collect stool and buccal samples which will be used for microbiota profiling. Participants will receive kits in advance to collect the stool, and oral sample at home. Additionally, participants will receive a Smartwatch to track their physical activity performance.\n\nIn the second segment of the study, participants will be randomized into two groups: antibiotics or placebo, which will be consumed for 7 days.\n\nThe third segment of the trial, Participants will be allocated into three groups, to receive either 15 Autologous fecal microbiota transplantation (aFMT) capsules or 15 identical placebo capsules (participants who received antibiotics will be divided into 2 groups to receive fecal microbiota transplantation (FMT) or placebo, and participants who received placebo will receive placebo in this segment as well). The FMT will take place for two consecutive days (a total of 30 capsules).\n\nOn the fourth meeting After all tests are done, participants who received antibiotic and haven't received aFMT will undergo an FMT administration (on meetings 4-5). The FMT will take place on two consecutive days (a total of 30 capsules) in the same manner it was described above. The other 2 groups will receive a placebo capsules as described above.\n\nParticipants will undergo physical abilities tests (VO2max test, muscle strength will be valued with \"System 4 Pro™ BIODEX \" or a manual dynamometer, high jumps, 30 seconds jumps, flexibility. Before, immediately after, and following 1,3, 5, 7 and 9 minutes of the 30 seconds jumps, finger prick blood samples will be taken for lactate measurement), anthropometric measurements, medical history questioners, blood samples and body composition using DXA.\n\nAll adverse events will be documented and reported as necessary to the study doctor and the ethical committee.\n\nAn additional cohort of 18 days (group b) will be recruited in order to examine the role of the gut microbiome in contributing to exercise capacity, particularly through D-lactate generation.\n\nParticipants will be asked to perform cycles of 4-minute efforts, increasing capacity by 10-15% per stage. Blood lactate at the end of each stage will be collected. Cycles will stop once the participant reached their lactate threshold, monitered by the finger prick lactate measurement and or if the participant cannot sustain the workload. Similarly to the first cohort, participants will be randomized to receive either antibiotics or placebo. Participants in the antibiotics arm will receive their aFMT to restore their pre-antibiotic gut microbiome, by ingesting 30 pills of FMT, and the placebo group will receive 30 pills of Cellulose.",[37,45,51],{"label":38,"type":39,"description":40,"interventionNames":41},"Antibiotics + FMT","EXPERIMENTAL","7 days of antibiotics- Ciprofloxacin, 500 mg 2\u002Fday \\& Metronidazole (Flagyl), 500 mg 3\u002Fday. After antibiotics administration, participants will receive 15 aFMT capsules for two consecutive days (a total of 30 capsules). On the forth + fifth meeting, participants who received antibiotic FMT will receive a 30 placebo capsules",[42,43,44],"Drug: Antibiotics","Other: Autologous Fecal Microbiota Transplantation","Other: placebo capsules",{"label":46,"type":47,"description":48,"interventionNames":49},"Placebo","PLACEBO_COMPARATOR","7 days of placebo cellulose pills. After cellulose pills administration, participants will receive 15 placebo capsules for two consecutive days (a total of 30 capsules).\n\nOn the forth + fifth meeting, the participants will again receive 30 placebo capsules.",[50,44],"Other: Cellules Pills",{"label":52,"type":39,"description":53,"interventionNames":54},"Antibiotics+placebo","7 days of antibiotics- Ciprofloxacin, 500 mg 2\u002Fday \\& Metronidazole (Flagyl), 500 mg 3\u002Fday. After antibiotics administration participants will receive 15 placebo capsules. On the forth + fifth meeting the participants will receive 15 aFMT capsules for two consecutive days (a total of 30 capsules).",[42,43,44],[56,63,70,74],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"DRUG","Antibiotics","Ciprofloxacin, 500 mg 2\u002Fday \\& Metronidazole (Flagyl), 500 mg 3\u002Fday.",[38,52],[62],"Ciprofloxacin & Metronidazole",{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"OTHER","Autologous Fecal Microbiota Transplantation","Autologous Fecal Microbiota Transplantation( aFMT( stool taken from the participant, prior to antibiotic treatment)",[38,52],[69],"FMT",{"type":64,"name":71,"description":72,"armGroupLabels":73,"otherNames":28},"Cellules Pills","7 days of cellules placebo pills.",[46],{"type":64,"name":75,"description":76,"armGroupLabels":77,"otherNames":28},"placebo capsules","Placebo capsules consist of saline\u002Fglycerol (the same vehicle as in a FMT capsules)",[38,52,46],[79],{"name":80,"affiliation":81,"role":82},"Ilan Youngster, Dr.","Assaf-Harofeh MC, Bee'r Yaakov Israel","PRINCIPAL_INVESTIGATOR",[84],{"name":80,"role":85,"phone":86,"phoneExt":28,"email":87},"CONTACT","+972-50630119","youngsteri@asaf.health.gov.il",[89],{"facility":90,"status":91,"city":92,"state":28,"zip":28,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Weizmann Institute of Science","RECRUITING","Rehovot","Israel","IL",{"type":96,"coordinates":97},"Point",[98,99],34.81199,31.89421,{"lat":99,"lon":98},[102],{"name":103,"role":85,"phone":104,"phoneExt":28,"email":105},"Shimrit Eliyahu Miller","08-9529089","shimrit.miller@weizmann.ac.il",{"type":82,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Ilan Youngster","Manager- Microbiome Center",[110,111],{"name":90,"class":64},{"name":112,"class":64},"Wingate Institute","100441119","assessing-the-potential-role-of-the-gut-microbiome-in-modulating-physical-abilities-in-humans-100441119",false,"NCT05024188","Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans","Inclusion Criteria:\n\n* Age - 20-55\n* Are used to exercise in aerobic sports (running, swimming, 'zumba', ball games, functional training, surfing, tennis, wrestling ext.).\n* Exercise at least twice a week, for a minimum duration of the last 6 months.\n\nExclusion Criteria:\n\n* Consumption of antibiotics (PO) or probiotics 3 months prior to the first day of the experiment.\n* Diagnosis of type 1 or type 2 diabetes.\n* Pregnancy, fertility treatments, breastfeeding women six months prior to enrollment and during the study.\n* Chronic disease-under the discretion of the study medical team (e.g. AIDS, Cushing syndrome, Chronic kidney disease (CKD), acromegaly, hyperthyroidism etc.)\n* Cancer and recent anticancer treatment\n* Psychiatric disorders\n* Coagulation disorders\n* Gastrointestinal disorders\n* Bariatric surgery\n* Alcohol or substance abuse\n* Any physical condition precluding the completion of a routine effort test\n* Allergy to Flagyl (Metronidazole) and\u002F or Ciprodex (Ciprofloxacin)",true,"ALL","20 Years","55 Years",{"count":124,"type":125},70,"ESTIMATED","INTERVENTIONAL",[128],"NA","The intestinal microbiome is a microbial system that is influenced by host genetics and environmental exposures such as nutrition, stress and medications. There is a growing body of evidence indicating the significant contribution of the gut microbiome to host health and disease. Furthermore, it has been shown that exercise may modify the microbiome composition. However, important mechanistic questions related to the possible associations between exercise and the human gut microbiome remain unanswered.\n\nIn this study, the investigators are using advanced state-of-the-art measurements of physical activity level and related metabolic parameters whether there is a connection between the microbiome and physical abilities in healthy participants and whether antibiotics consumption can influence host physical abilities and glycemic responses through changes induced in microbiome composition and function.",[131,69],"Physical Abilities","2026-10-07",{"date":134,"type":135},"2026-10-13","ACTUAL",{"date":137,"type":135},"2022-06-29",{"date":139,"type":125},"2029-12-31",{"name":5,"class":6},1]