[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Örebro University, Sweden\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":320},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,77,100,123,146,178,208,241,262,290],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100527002","digestibility-of-different-plant-based-proteins-in-humans-with-ileostomy-100527002",false,"NCT06142084","Digestibility of Different Plant-based Proteins in Humans With Ileostomy","True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model","PAN-Prodig","Inclusion Criteria:\n\n* Age: 18 - 75 years\n* Body mass index: 18.5 - 30 kg\u002Fm2\n* (double-loop) Ileostomy with an intact small bowel\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Ileostomy \\\u003C 3 months before the study\n* Any clinically significant present or past disease\u002Fcondition other than colon cancer which in the investigator's opinion could interfere with the results of the trial\n* Any clinically significant present or past medication which in the investigator's opinion could interfere with the results of the trial","ALL","18 Years","75 Years",{"count":5,"type":21},"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this interventional study is to learn about the digestibility of different plant-based proteins in adults (age 18-75) with an ileostomy.\n\nThe main questions the study aims to answer are:\n\n1. How does the digestibility of proteins in the small intestine differ between different plant-based proteins?\n2. Which proteins and amino acids are not digested or absorbed in the small intestine and are available for further metabolic processes in the large intestine?\n3. How do metabolites in the collected content of the ileostomy bag differ after consuming different plant-based proteins?\n4. Can the in vivo results be compared to results from existing in vitro models?\n\nParticipants will consume five different protein meals (oat protein - high bioavailable, oat protein - low bioavailable, pea protein - high bioavailable, pea protein low bioavailable, protein-free meal) on five different study days in a random order. Five hours after consuming the test meals ileostomy bags will be collected and the content will be analysed to answer the above mentioned research questions.",[27],"Ileostomy - Stoma",[29,30,31],"Protein","Plant-based","Digestibility","RECRUITING","2026-06-22",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":21},"2026-09",{"date":40,"type":21},"2028-12",{"name":42,"class":43},"Örebro University, Sweden","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":44},"100637075","the-effect-of-low-or-high-dietary-fiber-diet-on-volatile-organic-compounds-in-exhaled-breath-of-healthy-individuals-100637075","NCT07594600","The Effect of Low or High Dietary Fiber Diet on Volatile Organic Compounds in Exhaled Breath of Healthy Individuals","Characterization of Fiber-degrading Microbiota in Individuals Without Gastrointestinal Diseases","FIBRE-MATCH","Inclusion Criteria:\n\n1. Signed informed consent obtained prior to any study-related procedures.\n2. Willingness to refrain from regular consumption of prebiotic or probiotic products, as well as medications known to affect gastrointestinal function, for at least four weeks prior to the study visits.\n\nExclusion Criteria:\n\n1. History of complicated gastrointestinal surgery.\n2. Presence of a gastrointestinal diagnosis or any condition that, in the opinion of the principal investigator, may influence the study outcomes.\n3. Current diagnosis of a psychiatric disorder.\n4. Systemic use of antibiotics or steroid medications within the past 3 months.\n5. Frequent use of NSAIDs (non-steroidal anti-inflammatory drugs) within the 2 months preceding the study visit.\n6. Regular consumption of prebiotic or probiotic products within the past 4 weeks.\n7. Alcohol or substance abuse.\n8. Current smoking or use of nicotine pouches.\n9. Frequent use of laxatives, antidiarrheal agents, or anticholinergic medications within the 12 weeks preceding the study visit.\n10. Pregnancy or breastfeeding.\n11. Respiratory disease or infection.",true,"65 Years",{"count":56,"type":21},20,[24],"The aim of this crossover intervention study is to evaluate the volatile organic compounds (VOCs) present in participants at baseline and how these levels change after consuming either a low- or high-dietary fiber diet for three days. This study will involve adults, 18-65 years old, without any gastrointestinal diseases.\n\nThe primary objectives are to characterize baseline VOC profiles, assess changes in these profiles after a short-term dietary fiber intervention, determine if specific VOC patterns correlate with dietary fiber intake, and identify the time points at which VOC levels peak. This information will help establish the optimal timing for breath sampling and potentially provide insight into how VOC patterns relate to dietary fiber consumption and degradation.\n\nThe expected outcome is that a high-dietary fiber diet will produce a VOC profile enriched in metabolites associated with fiber fermentation compared to a low-dietary fiber diet, and that these VOCs will be consistent with those identified in vitro during fecal fermentation. Each participant will serve as an internal control, enabling within-subject comparisons of VOC levels at baseline and following the dietary fiber intervention.\n\nParticipants will receive a whole-food product that is rich in dietary fiber and will consume either a low-fiber diet (10 g\u002Fday) or a high-fiber diet (40 g\u002Fday) for three days. On the first day of each intervention, participants will also ingest a pH capsule to monitor gastrointestinal pH continuously throughout the three days. After a three-week washout period, participants will cross over to the other intervention arm and undergo another round of gastrointestinal pH monitoring.\n\nIn addition to the dietary intervention, participants will complete food and health questionnaires to assess habitual fiber intake and dietary habits. Fecal samples will be collected for in vitro fermentation to functionally profile the gut microbiota by assessing fecal VOCs, short-chain fatty acids (SCFA), and the microbial enzymatic activity and its pH-dependent modulation.",[60,61],"Healthy Adults","Dietary Fiber Fermentation",[63,64,65,66,67,68],"Volatile Organic Compounds","Food Intervention","Healthy participants","No gastrointestinal diseases","Without gastrointestinal diseases","Dietary Fiber","2026-06-01",{"date":71,"type":36},"2026-06-04",{"date":73,"type":21},"2026-05-25",{"date":75,"type":21},"2027-03",{"name":42,"class":43},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":44},"100633523","monitoring-changes-in-blood-circulating-metabolites-using-minimally-invasive-techniques-100633523","NCT07527793","Monitoring Changes in Blood Circulating Metabolites Using Minimally Invasive Techniques","MicroFastFood","Inclusion Criteria:\n\n1. Age: 18-65 years old\n2. Body Mass Index (BMI): 18.5-29.9 kg\u002Fm2\n3. Weight stability within the previous 3 months (self-reported).\n4. Positive intention to maintain usual routine physical activity and eating habits during the study.\n\nExclusion Criteria:\n\n1. Presence of acute chronic diseases, inflammatory or functional gastrointestinal disorders, or any diagnosed disease condition that disrupt daily routine activities.\n2. Routine use medications or supplements that could potentially interfere with the study outcomes\n3. History of eating disorder\n4. Recent use of antibiotic medication within the last 3 months prior to the first visit\n5. Active efforts to lose weight\n6. Smoking\n7. Consumption of alcoholic drinks exceeding nine standard cups per week and\u002For more than three standard cups per occasion",{"count":85,"type":21},35,[24],"This study investigates short-term intra- and inter-individual variability in human blood metabolism under real-life conditions. Using minimally invasive finger-prick blood sampling, dietary records, and wearable devices, we will longitudinally monitor blood-circulating metabolites and glucose levels in healthy individuals over a four-week period without dietary or lifestyle intervention. The study focuses on metabolic transitions between pre- and postprandial states during habitual daily activities and routine meals. Mass spectrometry-based metabolomics will be used to characterize metabolite profiles and their associations with diet, physical activity, sleep, and stress. In parallel, the study evaluates the feasibility of microsampling approaches, wearable-derived physiological data, and isotope-labelled standards for robust and cost-effective metabolite quantification. The results will inform the design of larger longitudinal studies using minimally invasive blood sampling in non-controlled settings.",[89],"Healthy Participants",[91],"Metabolomics, lipidomics, mass spectrometry, microsampling","2026-04-07",{"date":94,"type":36},"2026-04-14",{"date":96,"type":36},"2026-01-21",{"date":98,"type":21},"2026-12-31",{"name":42,"class":43},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":44},"100603851","the-effects-of-a-probiotic-food-supplement-in-hyperuricaemia-100603851","NCT07141888","The Effects of a Probiotic Food Supplement in Hyperuricaemia","The Effects of a Novel Probiotic Food Supplement in Hyperuricaemia - Towards Development of an Individualised Treatment Strategy","Bugs4U-PoC","Inclusion Criteria:\n\n1. Signed informed consent prior to any study-related procedures\n2. Age 18-80 years old\n3. BMI range 17.5-40 kg\u002Fm2\n4. Blood uric acid above 405 μmol\u002Fl (6.8 mg\u002Fdl)\n5. Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages) during the study\n6. Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study\n\nExclusion Criteria:\n\n1. Recent (within last month) episode of gout\n2. Diagnosis of type 1 diabetes\n3. Diagnosed inflammatory bowel disease (IBD)\n4. Current diagnosis of psychiatric disease\u002Fs or syndromes\n5. Current diagnosis of neurodegenerative disease\n6. Current pregnancy or breastfeeding\n7. History of complicated gastrointestinal surgery\n8. (Partial) resection of the small intestine or colon\n9. Regular use of urate-lowering treatment (apart from allopurinol) in the month prior to inclusion\n10. Oral or intravenous administration of antibiotics and\u002For corticosteroids in the 4 months prior to inclusion\n11. Regular use of any non-steroidal anti-inflammatory drug (NSAID) during the last month prior to inclusion (apart from low-dose acetylsalicylic acid)\n12. Consumption of more than 9 standard glasses of alcohol-containing drinks per week and\u002For more than 4 standard glasses per occasion\n13. Regular use of probiotic or prebiotic supplementation in the month prior to inclusion\n14. Any condition or intake of medication which could substantially interfere with the outcome of the study, as decided by the principal investigator's discretion","80 Years",{"count":110,"type":21},99,[24],"The overall aim of the project is to determine whether a daily intake of health-promoting bacteria, known as probiotics, with or without a dietary fiber, affects uric acid levels in individuals with elevated levels of uric acid in the blood (hyperuricemia). Additionally, the project will investigate which individuals benefit from this dietary supplement and which do not, based on factors such as gut microbiota composition and function, dietary habits, genetic factors, and inflammatory status. The ultimate goal is to develop a personalized therapy for hyperuricemia.\n\nAt the beginning of the study, blood samples will be taken to determine uric acid levels and 99 individuals with hyperuricemia will be invited to participate in a 6-week intervention study with daily intake of dietary supplements. To examine the effect of the supplement on various health variables, blood, urine, stool, and breath samples will be collected on several occasions.\n\nTo better understand the underlying factors of hyperuricemia, questionnaire data and results from biological will be compared between participants with normal versus elevated uric acid levels. Furthermore, different outcome parameters from questionnaires and samples before and after supplement intake will be compared. In addition, various methods for estimating dietary intake will be investigated and compared with each other.",[114],"Hyperuricemia With or Without Gout","2026-03-26",{"date":117,"type":36},"2026-03-27",{"date":119,"type":36},"2025-12-16",{"date":121,"type":21},"2027-12",{"name":42,"class":43},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":53,"sex":17,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":44},"100492255","promotion-of-healthy-lifestyle-habits-in-primary-care-settings-100492255","NCT05689762","Promotion of Healthy Lifestyle Habits in Primary Care Settings","PCrorelse","Inclusion Criteria:\n\n* age, high metabolic risk- poor lifestyle habits (diet and physical activity)\n\nExclusion Criteria:\n\n* overt disease","40 Years","70 Years",{"count":133,"type":21},100,[24],"Intervention aiming to promote healthy dietary and physical activity behaviors in adults with different socioeconomic status primary care settings",[137],"Healthy Lifestyle","2026-02-13",{"date":140,"type":36},"2026-02-18",{"date":142,"type":36},"2022-06-22",{"date":144,"type":21},"2028-01-10",{"name":42,"class":43},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":44},"100621140","acute-effects-of-a-urate-lowering-bacterial-therapeutic-on-small-intestinal-transcriptomics-and-glycomics-in-healthy-subjects-100621140","NCT07366749","Acute Effects of a Urate-lowering Bacterial Therapeutic on Small Intestinal Transcriptomics and Glycomics in Healthy Subjects","The Acute Effects of a Urate-lowering Probiotic Food Supplement\u002FBacterial Therapeutic on Small Intestinal Transcriptomics and Glycomics in Healthy Subjects","Bugs4U-MoA","Inclusion Criteria:\n\n* Signed informed consent.\n* Age 18-60 years.\n* BMI 18.5 - 29.9 kg\u002Fm².\n* Willing to avoid probiotics, fermented foods, and maintain stable diet\u002Flifestyle for the study duration.\n\nExclusion Criteria:\n\n* Chronic GI, inflammatory, metabolic (including renal), or significant psychiatric disease.\n* Acute infection\u002Fallergy within 2 weeks.\n* Regular use of NSAIDs, antibiotics, steroids, immunomodulators.\n* Alcohol \\>9 units\u002Fweek.\n* Use of recreational drugs, tobacco, or nicotine.\n* Known allergy to local anesthetics or sedatives for gastroscopy.\n* Bleeding disorder or use of anticoagulants.\n* Use of probiotics or antibiotics within 4 weeks prior.\n* Pregnancy, breastfeeding, or planning pregnancy.\n* Any condition deemed by investigator to compromise safety or data integrity","60 Years",{"count":156,"type":21},8,[24],"This is a pilot study investigating how a novel probiotic supplement (BEO001), with and without a dietary fiber (beta-glucan), affects the lining of the small intestine in healthy people. The main goal is to see if a single dose of the probiotic changes gene activity (transcriptomics) and sugar molecule patterns (glycomics) in the gut. Eight participants will take three different treatments (placebo, probiotic alone, probiotic with fiber) in a random order, with at least 10 days between each. A gastroscopy to collect small intestinal tissue samples (biopsies) is performed the morning after each treatment. Blood and breath samples are also collected at these visits to explore effects on metabolism and inflammation. To understand how different sampling methods compare, participants collect stool samples and simple rectal swabs at home before any treatment. Researchers analyze the sugar molecules and bacteria in these samples, then compare them to each other and to the gut tissue samples collected after treatment. This helps determine if easier-to-collect samples can provide similar information to gut biopsies. The study also aims to combine all data (including genetics and diet) to identify key targets for future research and to attempt to grow 'mini-gut' organoids from the biopsies. The results will help design larger future studies in people with high uric acid levels.",[160,161],"Healthy","Hyperuricemia, Gout",[163,164,165,166,167,168],"probiotics","gut microbiome","small intestine","transcriptomics","glycomics","urate metabolism","NOT_YET_RECRUITING","2026-01-16",{"date":172,"type":36},"2026-01-26",{"date":174,"type":21},"2026-02",{"date":176,"type":21},"2026-07",{"name":42,"class":43},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":187,"conditions":188,"keywords":192,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":4},"100619870","clinical-microbial-and-tissue-based-characterization-of-patients-treated-for-severe-temporomandibular-joint-pathology-100619870","NCT07350239","Clinical, Microbial and Tissue-based Characterization of Patients Treated for Severe Temporomandibular Joint Pathology","Prospective Clinical, Microbial and Tissue-based Characterization Analyses of Severe Temporomandibular Joint Pathology","Inclusion Criteria:\n\n* Patients subjected to open TMJ surgery such as arthroplastic surgery with or without autogen or allogen reconstruction\n* Preserved biobank material (resected bone and soft tissue).\n\nExclusion Criteria:\n\n* Absence of biobank material.\n* Inability to give informed consent.",{"count":56,"type":21},"OBSERVATIONAL","The general objective of this observational study is to clarify the clinical, microbial, and tissue characteristics, aetiology, and risk factors behind severe TMJ pathology. The main questions it aims to answer are:\n\n* What are the clinical and histologic characteristics of patients with severe pathology of the TMJ?\n* Can microbial DNA be found in TMJ tissue from patients with severe pathology of the TMJ, and if so, does this correlate to the outcome of the surgery?",[189,190,191],"TMJ Disorder","Ankylosis","Osteoarthritis",[193,194,195,196,197,198,199],"TMJ","Temporomandibular joint","TMJ disorder","oral and maxillafacial surgery","TMJ pain","TMJ ankylosis","Severe osteoarthritis","2026-01-13",{"date":202,"type":36},"2026-01-20",{"date":204,"type":21},"2026-03-01",{"date":206,"type":21},"2029-02-01",{"name":42,"class":43},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":216,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":239,"locationsCount":240},"100569242","evaluation-of-co-op-for-adolescents-with-mild-intellectual-disability-100569242","NCT06691698","Evaluation of CO-OP for Adolescents With Mild Intellectual Disability","Evaluation of The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach for Adolescents With Mild Intellectual Disability","CO-OPIF","Study I-II\n\nInclusion criteria\n\n* 13-17 years\n* Diagnosed mild intellectual disability\n* Motivation to reach self-selected goals\n* Ability to identify those goals\n* Possibility to meet once a week for ten weeks\n* Access to a parent or significant other for support during intervention\n\nExclusion criteria:\n\n* Movement related diagnosis (i.e. cerebral palsy or neuro muscular diseases)\n* Diagnosed attention deficit hyperactivity disorder\u002Fattention deficit disorder (ADHD\u002FADD) or autism spectrum disorder\n* Progressive diagnoses\n* Need for language interpreting\n* Need for alternative and augmentative communication (i.e. pictures or signs).\n\nStudy III\n\nInclusion criteria:\n\n* 13-17 years\n* Diagnosed mild intellectual disability\n* Completed CO-OP intervention or at lest half way trough the intervention\n* Opportunity to meet physically for an interview with in a month post and 6 months post intervention.\n* CO-OP intervention done with high fidelity to CO-OP format with a CO-OP therapist that has written field notes, preferrably recruited from study I-II.\n\nExclusion criteria:\n\n* Movement related diagnosis (i.e. cerebral palsy or neuro muscular diseases)\n* Diagnosed attention deficit hyperactivity disorder\u002Fattention deficit disorder (ADHD\u002FADD) or autism spectrum disorder\n* Progressive diagnoses\n* Need for language interpreting\n* Need for alternative and augmentative communication (i.e. pictures or signs).\n\nStudy IV\n\nInclusion criteria:\n\n* Parents with legal guardianship that lives full- or part time with an adolescent reaching the inclusion criteria for study I who has completed CO-OP within or out of the project\n* Opportunity to meet physically for an interview with in a month post and 6 months post the adolescent's completed, or at least half way through, CO-OP intervention.\n\nExclusion criteria:\n\n* Need for language interpreting\n* Need for alternative and augmentative communication (i.e. pictures or signs)\n* Irregular and brief living with the adolescent comparable to less than half-time and therefore does not observe the adolescent's occupational performance enough to answer the interview questions.","13 Years","17 Years",{"count":219,"type":21},60,[24],"Intellectual disability (ID) affects a person throughout life and includes difficulties to manage what is expected in everyday life based on age. One difficulty is to create strategies for and solve problems related to everyday occupations. Treatment options with good evidence to enhance occupational performance for persons with ID are limited. The Cognitive Orientation to Daily Occupational Performance (CO-OP) is an approach with good evidence within other diagnostic groups, i.e. adolescents with cerebral palsy. CO-OP has a unique person-centered approach where the person chooses his\u002Fher own goals and creates his\u002Fher own strategies to reach them. Initial research shows potential for CO-OP with adolescents with ID, although due to scientific flaws there is still a lack of evidence regarding feasibility and effectiveness for adolescents with ID. Based on the results with other diagnostic groups and clinical knowledge and experience, CO-OP can be assumed to be feasible and effective for adolescents with ID and to have a long term effect transferred to everyday life in a way other treatment options do not.\n\nThe aim of the project is to describe and evaluate CO-OP for adolescents with mild ID. Participants will be adolescents aged 13-17 and their parents. The project is designed as a feasibility study with two qualitative, one quantitative and one mixed method data collection. The quantitative data will be ordinal and nominal data from observational and self-assessment assessments. The mixed methods include comparison between filmed sessions and the CO-OP manual, use of field notes to analyse fidelity and needs for adaptations, and comparison between the CO-OP manual and policy documents. The qualitative outcome will be experiences by the adolescents and perceptions of CO-OP by parents.",[223],"Intellectual Disability, Mild",[225,226,227,228,229,230,231,232],"adolescents","executive function","metacognition","mild intellectual disability","occupational therapy","occupational performance","person-centered intervention","self-efficacy","2025-08-22",{"date":235,"type":36},"2025-08-29",{"date":237,"type":36},"2025-01-16",{"date":75,"type":21},{"name":42,"class":43},2,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":248,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":261,"locationsCount":44},"100591533","effects-of-fibres-combined-with-probiotics-on-uric-acid-in-an-ex-vivo-fermentation-model-100591533","NCT06981663","Effects of Fibres Combined With Probiotics on Uric Acid in an ex Vivo Fermentation Model","Potential Effects of Fibres Combined With Probiotics on Uric Acid and Related Metabolites in an ex Vivo Fermentation Model","Inclusion Criteria:\n\n1. Signed informed consent prior to any study-related procedures\n2. Age 18-80 years old\n3. BMI range 18.5-35 kg\u002Fm2\n4. Blood uric acid above 0.36 mmol\u002FL (6 mg\u002Fdl)\n5. Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages), until collection of faecal material\n6. Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study, until collection of faecal material\n\nExclusion Criteria:\n\n1. Diagnosis of type 1 and\u002For type 2 diabetes\n2. Diagnosed inflammatory bowel disease (IBD)\n3. Current diagnosis of psychiatric disease\u002Fs or syndromes\n4. Current diagnosis of neurodegenerative disease\n5. Current pregnancy or breastfeeding\n6. History of complicated gastrointestinal surgery\n7. Systemic use of antibiotics and\u002For steroid medication in the last 4 months prior to inclusion\n8. Regular use of any non-steroidal anti-inflammatory drug (NSAID) for the last 2 months\n9. Consumption of any NSAID within 3 days of sample collection\n10. Current (or within the last 4 weeks prior to study start) use of probiotic supplementation\n11. Any condition or intake of medication which could substantially interfere with the outcome of the study, as decided by the principal investigator's discretion\n12. After being included in the study and until collection of faecal material, starting any medication or treatment that could potentially influence the study participation and\u002For study analysis",{"count":249,"type":21},15,"In this study, we will collect faecal samples from individuals with hyperuricaemia (assessed by blood test) and perform in vitro faecal fermentation studies to assess how probiotics in combination with fibres affect urate metabolism in these faecal samples.",[252],"Hyperuricemia",[254],"hyperuricemia","2025-08-11",{"date":257,"type":36},"2025-08-12",{"date":259,"type":36},"2025-06-12",{"date":40,"type":21},{"name":42,"class":43},{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":277,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},"100511152","evaluation-of-a-home-based-parenting-support-program-parenting-young-children-100511152","NCT05935722","Evaluation of a Home-based Parenting Support Program: Parenting Young Children","Evaluation of a Home-based Parenting Support Program - Parenting Young Children - for Parents With Intellectual and Developmental Disabilities When There is a Risk for Neglect","PYC","Inclusion Criteria:\n\n* Parents with IDDs, including ID and other cognitive disabilities (e.g., ADHD and ASD).\n* Parents must have children aged 0-9 years living at home and be assessed by the social services to be eligible for tailored parenting support.\n\nExclusion Criteria:\n\n* Ongoing substance abuse, and\u002For mental illness of such nature and degree that it may affect parent management training.\n* Ongoing child abuse.",{"count":219,"type":21},[24],"Background: Parents with intellectual and developmental disabilities (IDDs) have a tendency to provide insufficient caregiving and often need parenting support to prevent neglect and child removal. However, parents with IDDs are not provided with appropriate support, and there is a lack of evidence-based programmes tailored to these parents' needs. Parenting Young Children (PYC) is a home-based parenting programme developed for parents with IDDs. PYC has shown promising clinical results in interview-based studies, but there is no evidence of its effectiveness. The purpose of the proposed study is to evaluate the PYC programme for improving parenting in parents with IDDs where there is risk of child neglect. The study will include a quantitative evaluation, a process evaluation, and a qualitative evaluation of the children's and parents' perspectives on participating in PYC.\n\nMethods: The quantitative evaluation will have a multi-centre, non-randomised, comparative study design. Eligible for participation are parents with IDDs who have children aged 0-9 years living at home and who are assessed as needing tailored parenting support. Thirty parents receiving PYC and thirty parents receiving treatment as usual (TAU) will be recruited from Swedish municipal social services. Outcome variables will be examined before and after the intervention, with a follow-up 6 months after completing the intervention. The primary outcome will be goal-attainment in parenting skills, and secondary outcomes will be parental self-efficacy and children's wellbeing. Interview methods will be used to explore the perspectives of parents and children in the PYC group.\n\nDiscussion: This study is motivated by the need for evidence-based support for parents with IDDs, and it focuses on upholding the centrality of child-caregiver relationships and family preservation, as well as children's rights and the rights of people with disabilities. Social services have expressed ethical concerns with employing a randomized design for this vulnerable group, and this study will therefore evaluate PYC in a non-randomized comparative study.",[274,275,276],"Intellectual Disability","Attention Deficit Hyperactivity Disorder","Autism Spectrum Disorder",[278,279,280,281],"Intellectual and developmental disabilities","parents","parenting skills","support programme",{"date":283,"type":36},"2025-08-14",{"date":285,"type":36},"2022-09-08",{"date":287,"type":21},"2026-06-30",{"name":42,"class":43},5,{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":305,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},"100536042","a-mixed-method-pilot-investigation-of-paradoxical-intention-for-insomnia-100536042","NCT06259682","A Mixed-method Pilot Investigation of Paradoxical Intention for Insomnia.","A Mixed-method Pilot Investigation of Paradoxical Intention for Insomnia. Assessing Acceptability, Feasibility and Preliminary Effectiveness.","Inclusion Criteria:\n\n* Undergoing three screening phases: a web-based questionnaire, a telephone interview with a structured assessment, and a 7-day sleep diary completion.\n* Screening resulting in diagnosis of insomnia, including co-morbid insomnia.\n* Participant should fulfill the following DSM-5 criteria. (1)Difficulty in sleep Initiation, maintenance, or early morning awakening. (2)Frequency and duration of at least three nights per week and has been present for at least three months.(3) Problems persist despite candidates having had adequate opportunity and circumstances for sleep. (4) The sleep disturbance causes significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.\n* Age above 18 and Swedish resident and language proficient.\n\nExclusion Criteria:\n\n* Severe depressive episode with suicidal intentions or actions\n* Current or past diagnosis of psychotic or bipolar disorders\n* Current substance use disorder\n* Recent changes in psychopharmacotherapy (within the last three months) or use of \"as-needed\" hypnotic medications during the trial.","90 Years",{"count":299,"type":21},40,[24],"The investigators aim to test the preliminary efficacy as well as the acceptability and feasibility of paradoxical intention, which is a psychotherapeutic technique, for improving insomnia symptoms in adults. Previous research has tested this technique for insomnia and found overall positive results. However, during the last decades very few studies have examined paradoxical intention. Therefore the investigators wish to conduct a pilot study examining the effects in a modern context.",[303,304],"Insomnia","Comorbidities and Coexisting Conditions",[306,307,308,309,310],"Insomnia disorder","mechanisms","mixed-methods","paradoxical intention","sleep performance anxiety","2024-08-14",{"date":313,"type":36},"2024-08-15",{"date":315,"type":21},"2024-09",{"date":317,"type":21},"2026-06",{"name":42,"class":43},3,""]