[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595529":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":31,"centralContacts":41,"locations":31,"responsibleParty":51,"collaborators":31,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":31,"enrollmentInfo":66,"targetDuration":31,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":81,"overallStatus":85,"whyStopped":31,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":31},{"fullName":5,"class":6},"University of Castilla-La Mancha","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group - Physical Activity + Probiotics","EXPERIMENTAL","Participants in this arm will engage in a structured physical activity program for 12 weeks, followed by a 6-week period during which they will continue the exercise regimen and begin daily intake of a probiotic supplement (AB-DR7, containing Lactiplantibacillus plantarum CECT 7481). The goal is to assess the combined effects of physical activity and probiotics on gut microbiota, physical condition, and quality of life in older adults.",[13,14],"Other: Dietary Supplement","Behavioral: Structured Physical Activity Program",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group A - Sedentary + Probiotics","ACTIVE_COMPARATOR","Participants in this arm will maintain their usual sedentary lifestyle throughout the study. After the initial 12-week observation period, they will begin a 6-week daily intake of the same probiotic supplement (AB-DR7). This arm is used to evaluate the effects of probiotics alone on gut microbiota and health indicators in the absence of physical activity.",[13],{"label":21,"type":22,"description":23,"interventionNames":24},"Control Group B - Sedentary + Placebo","PLACEBO_COMPARATOR","Participants in this arm will maintain a sedentary lifestyle and receive a placebo capsule identical in appearance to the probiotic, but containing maltodextrin instead of Lactiplantibacillus plantarum. This group serves as the baseline comparator to assess the natural variation in outcomes without intervention.",[25],"Other: Placebo",[27,32,36],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Dietary Supplement","A daily oral capsule containing 1 x 10⁹ CFU of Lactiplantibacillus plantarum CECT 7481 (32.5 mg), microcrystalline cellulose (304.1 mg), and magnesium stearate (3.4 mg). Administered once daily before the main meal for 6 weeks. Used to evaluate its effects on gut microbiota and physical health in older adults.",[16,9],null,{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Placebo","A daily oral capsule identical in appearance to the probiotic capsule, containing maltodextrin instead of Lactiplantibacillus plantarum. Administered once daily before the main meal for 6 weeks. Used to control for placebo effects in the assessment of probiotic efficacy.",[21],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"BEHAVIORAL","Structured Physical Activity Program","A 12-week supervised physical activity program conducted at municipal sports centers. Participants engage in moderate-intensity exercise at least 2 times per week. Designed to assess the impact of physical activity on gut microbiota, physical condition, and quality of life in older adults.",[9],[42,47],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},"Jose Luis Felipe, PhD","CONTACT","+34648885392","joseluis.felipe@uclm.es",{"name":48,"role":44,"phone":49,"phoneExt":31,"email":50},"Raquel Aparicio Mera, MsC","+34689061886","raquel.aparicio@uclm.es",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Jose Luis Felipe","Senior Lecturer","100595529","probiotics-and-active-aging-enhancing-gut-health-100595529",false,"NCT07033637","Probiotics and Active Aging: Enhancing Gut Health","Promoting Health Through Symbiosis: Exploring the Relationship Between Gut Microbiota, Probiotics, and Physical Activity in Older Adults","PAAEGH","Inclusion Criteria:\n\n* Adults aged 60 years or older.\n* Residents of Castilla-La Mancha or Madrid.\n* Able to provide informed consent.\n* For the intervention group: enrolled in a municipal physical activity program with a minimum frequency of 2 sessions per week.\n* Willing to participate in all assessments and follow study instructions.\n* Consent: Participants must provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Recent serious musculoskeletal injuries (e.g., muscle tears, ligament ruptures, fractures).\n* Current symptoms during exercise such as chest pain, dizziness, or joint pain.\n* Uncontrolled hypertension (≥160\u002F100 mmHg).\n* Recent cardiac failure or infectious disease (e.g., meningitis, hepatitis, flu).\n* Chronic gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, IBS).\n* Regular use of medications affecting gut motility or microbiota (e.g., laxatives \\>3 times\u002Fweek).\n* Immunodeficiency (e.g., HIV, active cancer).\n* Use of antibiotics (oral or parenteral) within 4 weeks prior to the study.\n* Regular intake of probiotic supplements or foods (e.g., Actimel) within 2 weeks prior to the study.",true,"ALL","60 Years",{"count":67,"type":68},90,"ESTIMATED","INTERVENTIONAL",[71],"NA","The general objective of this clinical trial is to assess the physical fitness and gut microbiota of older adults, thereby highlighting the importance of focusing on health maintenance. By making use of available resources and fostering collaboration among the elements involved in the study, more specific objectives can be defined:\n\n1. To determine the state of the gut flora in older adults through the analysis of the intestinal microbiota.\n2. To identify changes in the intestinal microbiota resulting from the intake of probiotics in older adults.\n3. To evaluate the effects of the intestinal microbiota in older adults participating in a training programme.\n4. To assess the physical fitness and perceived quality of life in older adults who engage in sport activities supported by technology.\n\nParticipants will:\n\n* Perform physical tests such as the 6-Minute Walk Test (6MWT), the Timed Up and Go (TUG), and the Sit-to-Stand test.\n* Complete wellbeing questionnaires to assess their perceived quality of life and health status.\n* Complete dietary habit questionnaires.\n* Provide stool samples for microbiota analysis.\n* Take part in exercise interventions or placebo exercise sessions, depending on their assigned group.",[74,75,76,77,78,79,80],"Gut -Microbiota","Older People","Physical Activity","Physical Fitness","Mental Health","Probiotic","Healthy",[82,83,84],"older people","gut microbiota","physical activity","NOT_YET_RECRUITING","2025-06-13",{"date":88,"type":89},"2025-06-24","ACTUAL",{"date":91,"type":68},"2025-09-01",{"date":93,"type":68},"2026-06-30",{"name":53,"class":6}]