[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spondylitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spondylitis":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,57,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":39,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100486132","gene-expression-profiles-in-spinal-tuberculosis-100486132",false,"NCT05610098","Gene Expression Profiles in Spinal Tuberculosis.","Comparing Gene Expression Profiles of Adults With Isolated Spinal TB to Disseminated Spinal TB Identified by 18FDG-PET\u002FCT at Time of Diagnosis, 6-and 12-months Follow-up","SpinalTBX","Inclusion Criteria\n\n1. Participant has completed the written informed consent process prior to undergoing any clinical evaluations and willing to undergo HIV testing\n2. TB spine based on clinical and radiological criteria\n3. Age 18 or older with a body weight of at least 40 kg body weight\n4. Able and willing to return to follow-up\n5. Willing to have samples, including DNA including RNA extraction, stored\n6. Willing to consistently practice a highly reliable method of pregnancy prevention\n\nExclusion Criteria\n\n1. Pregnancy or active desire to become pregnant within the next 6 months.\n2. Uncontrolled diabetes (HbA1c ≥ 6.5% \u002F random glucose concentration ≥11.1 mmol\u002Fl, fasting plasma glucose ≥ 7.0 mmol\u002Fl)\n3. Alcohol and substance abuse which might interfere with medication adherence during the trial\n4. Positive SARS-CoV-2 PCR in the past 4 weeks\n5. Suspicion of malignancy on MRI or known malignancy\n6. Suspicion of inflammatory disease and other rheumatological conditions\n7. Any person for whom the physician feels this study is not appropriate","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","Tuberculosis (TB) is one of the top ten causes of death worldwide with approximately 10 million cases globally and 1.2 million deaths. Sub-Saharan Africa carries the highest burden of TB. South Africa has one of the highest HIV and TB rates worldwide with an HIV prevalence rate in adults of 19% and a TB case notification rate of 615\u002F100,000 in 2019. Over many years, focus has been paid to pulmonary TB and extrapulmonary TB (EPTB) has received only little attention even though it accounts for almost a quatre of all TB cases. The diagnosis of EPTB remains challenging simply because sample collection requires invasive procedures in the absence of a blood-based diagnostic test. Spinal TB (spondylitis or spondylodiscitis caused by Mycobacterium tuberculosis) - often known as Pott's disease - accounts for up to 10% of EPTB and affects young children, people with HIV-coinfection and elderly, and often leads to lifelong debilitating disease due to devastating deformation of the spine and compression of neural structures. Little is known with regards to the extent of disease and isolated TB spine as well as a disseminated form of TB spine have been described. The latter presents with a spinal manifestation plus disseminations to other organs such as the lungs, pleura, lymph nodes, the GIT or urinary tract or even the brain.\n\nIn the Spinal TB X cohort, the investigators aim to describe the clinical phenotype of spinal TB using whole body PET\u002FCT and identify a specific gene expression profile for the different stages of dissemination and compare findings to previously described signatures for latent and active pulmonary TB. A blood-based test for spinal TB would lead to earlier diagnosis and treatment in all settings globally and improve treatment outcome of this devastating disease.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38],"Tuberculosis, Spinal","Tuberculosis, Osteoarticular","Tuberculosis","Mycobacterium Infections","Infections","Bone Diseases, Infectious","Musculoskeletal Diseases","Spinal Disease","Spondylitis","Spondylitis; Tuberculosis (Manifestation)","Spondylodiscitis","Positron-Emission Tomography","Diagnostic Imaging","Diagnostic Techniques and Procedures",[40,41,42,43],"Spinal TB","tuberculous spondylodiscitis","FDG-PET\u002FCT","POC","RECRUITING","2024-08-22",{"date":47,"type":48},"2024-08-23","ACTUAL",{"date":50,"type":48},"2022-10-25",{"date":52,"type":21},"2026-12-31",{"name":54,"class":55},"University of Cape Town","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":82,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100551493","axsend-exploring-immune-and-microbiota-effects-of-a-partial-enteral-nutrition-diet-in-axial-spondyloarthritis-100551493","NCT06460805","axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis","axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in People With Axial Spondyloarthritis","axSEND","Eligibility Criteria for Participants with axSpA\n\nInclusion criteria. Participants will fulfil ALL of the following:\n\n* Diagnosis of axSpA (fulfilling the ASAS criteria)\n* Active disease (BASDAI score ≥4) on day of study visit\n* Stable on treatment \\[defined as (1) no major change to therapy (change in treatment type) in the preceding 3 months AND (2) no minor change in therapy (adjustment of treatment dosage) in the preceding 1 month\\]\n* Age ≥ 16 years\n* Willing and able to give informed written consent.\n\nExclusion. Participants will have NONE of the following:\n\n* Pregnancy or breastfeeding\n* Prior diagnosis of IBD\n* Recipient of chemotherapy\u002Fimmunotherapy\u002Fradiotherapy in prior 3 months\n* Recent systemic antibiotic use (within last 1 month)\n* Current eating disorder\n* Food allergy incompatible with diet (e.g. cow's milk allergy)\n* Following a vegan diet\n* Major surgery in prior 3 months or planned in forthcoming 3 months.\n* Unable or unwilling to give informed consent\n* Unable or unwilling to try the PEN diet.\n\nEligibility Criteria for Healthy Volunteer Participants\n\nInclusion criteria. Participants will fulfil ALL of the following:\n\n* Age ≥ 16 years\n* Current student and\u002For staff member at the University of Glasgow\n* Willing and able to give informed written consent\n\nExclusion. Participants will have NONE of the following:\n\n* Pregnancy or breastfeeding\n* Prior diagnosis of an immune-mediated inflammatory condition\n* Recipient of chemotherapy\u002Fimmunotherapy\u002Fradiotherapy in prior 3 months\n* Recent systemic antibiotic use (within last 1 month)\n* Current eating disorder\n* Food allergy incompatible with diet (e.g. cow's milk allergy)\n* Following a vegan diet\n* Major surgery in prior 3 months or planned in forthcoming 3 months.\n* Unable or unwilling to give informed consent\n* Unable or unwilling to try the PEN diet.",true,"16 Years",{"count":68,"type":21},62,"INTERVENTIONAL",[71],"NA","People with axial spondyloarthritis (axSpA) often have intestinal inflammation and intestinal microbiome dysbiosis, with some similarities to Crohn's-like inflammatory bowel disease (IBD) gut inflammation. However, research has not addressed whether Partial Enteral Nutrition (PEN), a diet formed of a liquid formula and some solid whole foods, which is effective at inducing remission in IBD, may influence the dysbiotic microbiome and inflamed, hyperpermeable intestine of axSpA patients, and whether these changes may be accompanied by alterations in systemic markers of inflammation. Thus, there is a need to determine the effects of PEN on these aspects in axSpA patients.\n\nIn this study, the investigators intend to trial a 2-week course (with optional additional 2-week extension) of a PEN diet in people with active axSpA disease. A group of healthy volunteers following the same diet will act as a control.",[74,75,76,77,78,33,79,80,81],"Axial Spondyloarthritis","Ankylosing Spondylitis","Inflammation","Dysbiosis","Arthritis","Spondylarthritis","SpA","AxSpA",[83,84,85,86,87,88,89,90],"Partial Enteral Nutrition","Nutrition","Axial spondyloarthritis","Ankylosing spondylitis","axSpA","Diet","PEN","AS","2024-06-13",{"date":93,"type":48},"2024-06-14",{"date":95,"type":48},"2024-04-25",{"date":97,"type":21},"2025-08-01",{"name":99,"class":55},"NHS Greater Glasgow and Clyde",2,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":69,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":56},"100550785","phase-2-fecal-microbiota-transplantation-in-axial-spondyloarthritis-100550785","NCT06451588","Fecal Microbiota Transplantation in Axial Spondyloarthritis","Donor Versus Autologous Fecal Microbiota Transplantation for Axial Spondyloarthritis: a Double Blind, Placebo-Controlled, Randomized Trial","MicroSpA","Inclusion Criteria:\n\n* Axial Spondyloarthritis according to the ASAS classification criteria\n* Active disease defined as ASDAS ≥2.1 with elevated CRP ≥4 OR active inflammation on MRI within the last 3 months\n* Onset of axial SpA within last 10 years\n* Unsatisfactory relief of NSAIDs\n* On stable immunomodulatory treatment (TNFi, IL17i or JAKi) the last 3 months\n\nExclusion Criteria:\n\n* Planned dose adjustment or change in immunomodulatory treatment the next 90 days\n* Disease or disorder with life expectancy of ≤5 years\n* Severe immune deficiency (acquired, congenital og du to medication)\n* Previous treatment with FMT\n* Regular use of opioids with the exception of codeine and tramadol\n* Any specific diagnosis that could explain or contribute to the patients back pain (e.g. tumor, fracture, infection or degenerative disease)\n* Inflammatory spinal disease other than axSpA\n* Severe psychiatric disorder, alcohol- or drug abuse\n* Active inflammatory bowel disease\n* Microscopic colitis, diverticulitis or ileus\n* Active psoriasis\n* Fibromyalgia\n* Abdominal surgery excluding appendectomy, cholecystectomy, hysterectomy, caesarian section, sapling-ooforectomy and hernia surgery\n* Malignant disease excluding basalioma and melanoma stage 1\n* Conditions with expected necessary treatment with antibiotics during the study period, e.g. periodontitis end ischemic digital ulcers\n* Treatment with antibiotics 12 weeks prior to study entry\n* Pregnancy, lactation or planned pregnancy within the next 3 months\n* Contraindications for rectal catheter insertion\n* Planned rehabilitation program the next 90 days\n* Limited ability to comply with protocol requirements, including biobank participation","65 Years",{"count":111,"type":21},99,[113],"PHASE2","Although biologic therapy have revolutionized the treatment of Spondyloarthrtitis (SpA), many patients do not experience complete relief of SpA related complaints.\n\nIt has been established that patients with SpA have an altered composition of microorganisms (microbiota) in the gut compared to healthy controls, and that this correlates to disease activity and respons to therapy.\n\nThe goal of this randomized double-blind study is to evaluate the efficacy of fecal microbiota transplantation (FMT) in patients with axial SpA with a suboptimal effect of biologic therapy.\n\nThe main questions it aims to answer are:\n\n* Can FMT reduce disease activity in axial SpA?\n* Can FMT alleviate pain and reduce fatigue in axial SpA?\n* Is the composition of microorganisms restored to normal in patients with SpA after a treatment with FMT?\n\nParticipants will receive a single treatment in the form of an enema with either donor FMT or placebo at baseline. The primary endpoint will be evaluated after 90 days, but efficacy and safety will be monitored from baseline until 365 days.",[74,75,77,116,33,78,31,32,117],"Spondyloarthritis","Joint Diseases",[74,119,120,121,122,123],"Microbiome","Fecal Microbiota Transplantation","Microbiota","FMT","RCT","2024-06-04",{"date":126,"type":48},"2024-06-11",{"date":128,"type":48},"2024-06-01",{"date":130,"type":21},"2026-03",{"name":132,"class":55},"University Hospital of North Norway"]