[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University College Cork\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":494},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,46,84,115,137,155,177,207,235,264,290,318,346,372,396,424,442,473],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100639038","generating-intervals-of-reference-ffor-early-life-brain-biomarkers-100639038",false,"NCT07585149","Generating Intervals of Reference FFor Early Life Brain Biomarkers.","GIRAFFE","Inclusion Criteria:\n\n* Term neonate (≥37 weeks)\n* Planned routine venous blood drawn within one week of life\n* Relevant demographic\u002Fclinical information available, including gestational age, day of life, birth weight, sex, race, mode of delivery, and 5-minute Apgar score\n* Informed parental consent obtained prior to any study procedures\n\nExclusion Criteria:\n\n* Pre-term neonates \\\u003C37 weeks\n* Any clinical evidence of neurological\u002F CNS abnormalities.\n* NICU admission\n* Any neonates with Suspected or culture-positive sepsis or meningitis Any known inborn errors of metabolism (IEM). Any known chromosomal abnormalities or any apparent congenital abnormalities\n* When the relevant demographic\u002Fclinical information is not available.",true,"ALL","0 Days","7 Days",{"count":21,"type":22},150,"ESTIMATED","OBSERVATIONAL","Highly sensitive immunoassays for the detection of neuro-specific biomarkers are becoming more accessible. Currently, the majority of these biomarkers are detected with the use of labour-intensive and highly skilled wet lab work. However, recent advancements have allowed for the introduction of these neuro-specific biomarkers into mainstream clinical chemistry analysers, bringing them closer to clinical care. There is a vast amount of published literature for neuro-specific biomarkers in an adult and ageing population, unfortunately, the same cannot be said for the neonatal population. From the limited available literature, clear differences are being documented in physiological levels of neuro-specific biomarkers in adults and infants. Neuro-specific biomarkers such as GFAP (Glial Fibrillary Acidic Protein) and Tau are demonstrating promise for the early detection and prediction of neuro-developmental disorders. There is a need for an understanding of physiological levels of these neuro-specific biomarkers in a neonatal population before they can be fully adopted into clinical routine. The development of a neonatal reference interval for neuro-specific biomarkers may provide a foundation for the accurate interpretation of neuro-specific biomarker elevations in neonatal brain injury, aiding in the development of biomarker-based screening tools for early diagnosis and intervention.",[26,27,28],"Reference Intervals","Biomarker in Early Diagnosis","Neonatal",[30,31,28,32],"Neurospecific","Biomarker","Reference Interval","RECRUITING","2026-05-08",{"date":36,"type":37},"2026-05-13","ACTUAL",{"date":39,"type":37},"2026-04-13",{"date":41,"type":22},"2027-06-30",{"name":43,"class":44},"University College Cork","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":57,"studyType":23,"phases":4,"briefSummary":58,"conditions":59,"keywords":70,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100581994","assessing-intellectual-and-motor-outcomes-in-high-risk-infants-100581994","NCT06857539","Assessing Intellectual and Motor Outcomes in High-risk Infants","The ELEVATE Program for Prediction, Early Detection & Intervention in Cerebral Palsy","AIM-High","Inclusion Criteria (High Risk Group) :\n\n* Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol.\n* All infants considered high risk for a diagnosis of cerebral palsy and neuro-developmental impairment will be eligible, specifically including:\n\n  * All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight\n  * All encephalopathic infants\n  * Neurological risk factors (e.g., cerebral birth defect, injury\u002Fmalformation on neuroimaging, persistently abnormal neurological exam)\n\n(Control Group)\n\n-A control arm will also be recruited.\n\nExclusion Criteria:\n\n* Death prior to discharge from the neonatal unit (High-Risk Infants only)\n* No parental consent (High-Risk and Control Infants)","4 Months",{"count":56,"type":22},600,"30 Months","Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated issues with their motor skills. Some newborns are at higher risk of developing CP, including babies born prematurely, those who have an injury to their brain, and those who have an abnormal neurological examination. However, most babies with a higher risk of CP do not develop CP. The problem is that doctors can't tell early on who will and who will not develop CP, they can only say who has a risk of it. Therefore, these babies are followed up in out-patient clinics to see how they are progressing, usually by a neonatologist (baby doctor), often a physiotherapist, and some may also be referred to services in the community like the Early Intervention Team. If there is a significant concern, doctors will often perform a scan of the baby's brain to provide more information. Even with all this follow-up, it still usually takes at least 12 months, and can be up to 2 years, to diagnose a child as having CP.\n\nIn this study the aim is to try and reduce the age of diagnosis of CP by assessing children in high-risk out-patient clinics using novel and specific examinations. We would also like to improve our ability to predict who will need help with learning, language or other non-motor outcomes. This study is being conducted at several hospitals in Ireland, including Cork University Maternity Hospital (CUMH), The Rotunda Hospital and the Coombe Women and Infants Hospital. It is being coordinated by the In4kids network and will be conducted in the INFANT Centre\u002F University College Cork (UCC). The study has been funded by Research Ireland and the Cerebral Palsy Foundation, USA.",[60,61,62,63,64,65,66,67,68,69],"Cerebral Palsy","Cerebral Palsy (CP)","Cerebral Palsy Children","High-risk Infants","Intellectual and Developmental Disabilities","Motor Impairment","Cognitive Development","HIE - Hypoxic - Ischemic Encephalopathy","Preterm","Prematurity; Extreme",[60,71,72,73,74,75,76],"High-Risk Infant Follow-up","Motor Difficulty","Intellectual Delay","Cognitive Impairment","Hypoxic--Ischaemic Encephalopathy","Prematurity",{"date":36,"type":37},{"date":79,"type":37},"2025-03-21",{"date":81,"type":22},"2030-07-31",{"name":43,"class":44},4,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":16,"sex":17,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":45},"100631795","an-intervention-study-in-healthy-infants-aged-0-6-months-with-probiotics-lacticaseibacillus-rhamnosus-lra05-lra05-and-bifidobacterium-animalis-subsp-lactis-bla80-bla80-vs-placebo-for-promoting-gut-microbiome-development-100631795","NCT07505329","An Intervention Study in Healthy Infants Aged 0-6 Months With Probiotics Lacticaseibacillus Rhamnosus LRa05 (LRa05) and Bifidobacterium Animalis Subsp. Lactis BLa80 (BLa80) vs. Placebo, for Promoting Gut Microbiome Development.","SMILE","Inclusion criteria Written (electronic) informed consent provided by parent to allow their infant to participate in the study.\n\nNo antibiotic use since birth. Infant not to be taking any medications. Infant not to be taking probiotics. Breastfed or formula fed until weaning. Infants born via c-section or vaginally. Healthy male and female infants.\n\nExclusion criteria Infant is older than 3 months at the time their first study visit (Baseline visit).\n\nInfants who have a known diagnosis of inflammatory bowel disease or another medical condition.\n\nInfants with complex medical or behavioural needs that would deem the infant unable to participate in the study.\n\nHave a significant acute or chronic co-existing illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic) or any condition which contraindicates entry to the study according to the investigator's judgement.\n\nInfants who are receiving treatment involving experimental medications. Have a malignant disease or any concomitant end-stage organ disease. Infants born before 37 weeks of pregnancy.","1 Month","3 Months",{"count":94,"type":22},300,"INTERVENTIONAL",[97],"NA","The probiotics Bifidobacterium animalis subsp. lactis BLa80 and Lacticaseibacillus rhamnosus LRa05 have potential to enhance infant health and development based on previous research conducted on human infants.\n\nBifidobacterium animalis subsp. lactis BLa80 was isolated from healthy breast milk samples.\n\nTen clinical studies have been conducted using this strain, including randomized, double-blind, placebo-controlled trials, involving over 700 clinical subjects, adults and children. Based on the results from these studies, functional benefits associated with ingestion of this probiotic include relief of diarrhea, relief of constipation, improved sleep quality, resistance to H. pylori infection, modulation of gut microbiota, promotion of infant growth and development, gestational diabetes management and emotional management.\n\nLacticaseibacillus rhamnosus LRa05 was isolated from healthy baby faeces. Six clinical studies have been conducted, involving randomized, double-blind, placebo-controlled studies using this strain, involving over 500 clinical subjects. Based on the results from these studies, functional benefits associated with ingestion of this probiotic include relief of diarrhea, relief of eczema, resistance to H. pylori infection, modulation of gut microbiota, promotion of infant growth and development, and gestational diabetes management.\n\nThis proposal describes a three-year collaboration with APC Microbiome Ireland, INFANT Research Centre and WeCare to conduct clinical studies to investigate the effects of probiotics (Bifidobacterium animalis subsp. lactis BLa80 and Lacticaseibacillus rhamnosus LRa050), compared to a placebo, on the growth of infants and toddlers and the development of their gut microbiota. The focus of this study is on infant growth and gut microbiota development in infants up to 6 months old.",[100,101],"Less Than 3 Months Old","Healthy Infants",[103,104,105],"Gut microbiome","Oral probiotics","Healthy infants","NOT_YET_RECRUITING","2026-03-26",{"date":109,"type":37},"2026-04-01",{"date":111,"type":22},"2026-04",{"date":113,"type":22},"2028-03",{"name":43,"class":44},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":45},"100570623","microbiome-immunotherapy-neoadjuvant-assessment-100570623","NCT06709651","Microbiome Immunotherapy Neoadjuvant Assessment","Prospective Evaluation of the Breast Microbiome and Tumor Microenvironment-related Biomarkers of Response to Neoadjuvant Systemic Therapy in Triple Negative Breast Cancer","MINA","Inclusion Criteria:\n\n1. Be willing and able to provide written informed consent for the trial in accordance with national\u002Flocal guidelines.\n2. Be a male or female subject 18 years of age on day of signing informed consent.\n3. Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is:\n\n   HER2 negative in primary tumour pre-treatment by local pathology assessed according current ASCO\u002FCAP guidelines: In situ hybridization non-amplified (ratio of HER2 to CEP17 \\\u003C 2.0 or single probe average HER2 gene copy number \\\u003C 4 signals\u002Fcell), OR Immunohistochemistry (IHC) 0 or IHC 1+.\n\n   ER and PR negative in primary tumour pre-treatment defined as \\\u003C 10% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.\n4. Unresected, untreated breast cancer planned to undergo neoadjuvant systemic therapy, that meets one of the following clinical stages (see Appendix A):\n\n   o T2, T3, or T4a-d lesion, any N, M0\n5. Be willing to undergo mandatory research biopsy procedure at baseline (up to 4 core samples may be taken from this procedure).\n\nExclusion Criteria:\n\n1. Patients who are pregnant or breast-feeding\n2. Current use of any investigational agents\n3. History or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.","18 Years",{"count":125,"type":22},30,"Predictive biomarkers of response to combination chemotherapy and immune-checkpoint inhibitors are urgently needed to help tailor treatment recommendations for patients with early-stage TNBC. Tumour-associated microbiota in primary breast tumours represent promising and novel candidate biomarkers modulators of the efficacy of therapies for patients with TNBC. It has been shown that microbes colonizing breast tumours can modulate the efficacy of commonly used drugs and that the microbiome of breast tissue biopsies could represent a new biomarker. Data on the microbiome of patients with cancer indicate the potential for a new class of bacteria-based oncological biomarkers, for exploitation in precision oncology.",[128],"Triple Negative Breast Cancer","2026-03-02",{"date":131,"type":37},"2026-03-04",{"date":133,"type":37},"2024-10-02",{"date":135,"type":22},"2027-11",{"name":43,"class":44},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":45},"100558093","investigating-mechanistic-predictors-of-interpatient-variability-and-temozolomide-tmz-induced-haematological-toxicity-for-glioma-patients-100558093","NCT06546631","Investigating Mechanistic Predictors of Interpatient Variability and Temozolomide (TMZ) Induced Haematological Toxicity for Glioma Patients","Improve TMZ","Part A\n\nInclusion Criteria:\n\n1. 18 years of age or over\n2. Will receive or are currently receiving concurrent phase treatment with TMZ for high grade glioma (WHO Grade 3 or Grade 4 Astrocytoma, Oligodendroglioma or Glioblastoma).\n3. Provision of informed consent to participate.\n\nExclusion Criteria:\n\na. Patients who, in opinion of supervising clinician, are clinically too unwell to provide informed consent or for whom additional blood samples, or other research samples, would not be indicated or appropriate.\n\nPart B\n\nInclusion Criteria:\n\n1. 18 years of age or over\n2. Receiving or received treatment with TMZ for high grade glioma (WHO Grade 3 or Grade 4 Astrocytoma, Oligodendroglioma or Glioblastoma).\n3. Developed any CTCAE Grade ≥3 Haematological Toxicity associated with Temozolomide, and\u002For any 1 of:\n\ni. Platelet count \\\u003C100 x 109\u002FL ii. Neutrophil Count \\\u003C1.0 x 109\u002FL iii. Haemoglobin value \\\u003C8.0 g\u002FL iv. Omission of daily TMZ dose for ≥3 consecutive days during concurrent phase due to FBC concerns v. Deferral of subsequently due TMZ cycle by ≥7 days during adjuvant phase; vi. Dose reduction or permanent discontinuation of TMZ for reasons of haematological toxicity (as per treating physician discretion); vii. Use of growth factors, platelets or packed-cell transfusions during the course of TMZ.\n\nd. Provision of informed consent to participate.\n\nExclusion criteria:\n\na. Patients who, in opinion of supervising clinician, are clinically too unwell to provide informed consent or for whom additional blood samples, or other research samples, would not be indicated or appropriate.",{"count":145,"type":22},55,"A medication called temozolomide has been used for many years in the treatment of high-grade gliomas, which are tumours that originate in the brain. While this drug is the normal treatment for high-grade glioma, a number of patients develop a side-effect which results in low levels of some important blood cells, such as platelets or white blood cells. If this side-effect occurs, treatment with temozolomide may have to be stopped or paused, which may affect how well this treatment works.\n\nAt present, it is unknown why some patients develop this side effect and others do not. It is known that patients with a higher concentration of temozolomide in their blood are at an increased risk of developing this toxicity. There may be some factors associated with the movement of the drug in the body or the removal of the drug from the body which may affect the concentration of temozolomide in blood. There are many factors which may be involved, including genes, other medicines that are taken, how well kidneys and liver are working or even the microbiome (which is the bacteria in the gut).\n\nThis study is being done to find out what these factors could be. In the future, this may lead to medical care teams being able to predict which patients are at higher risk of side-effects, allowing them to implement measures to reduce the risk of this occurring.",[148],"Glioma",{"date":131,"type":37},{"date":151,"type":37},"2024-08-22",{"date":153,"type":22},"2027-12",{"name":43,"class":44},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":95,"phases":164,"briefSummary":165,"conditions":166,"keywords":170,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":45},"100505851","discontinuation-study-100505851","NCT05866757","Discontinuation Study","Discontinuation of Maintenance Therapy for the Patients Diagnosed With Multiple Myeloma in Sustainable Minimal Residual Disease (MRD) Negative Remission Without High Risk Features","Inclusion Criteria:\n\n1. 18 years of age or over\n2. Patient with diagnosis of multiple myeloma as per IMWC in first line of treatment (induction, consolidation, ASCT, maintenance is considered single line therapy for the purpose of this study, also discontinuation of 1 maintenance regimen due to toxicity and start of another is considered single line therapy for the purpose of this study).\n3. Received at least 2 years of maintenance therapy, defined as any anti-myeloma therapy to prevent disease recurrence and prolong time in remission\n4. Patients who have discontinued maintenance therapy earlier than 2 years due to side effects but also achieved sustained MRD negative CR might be also included\n5. Patients must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule, with the knowledge that they may withdraw consent at any time without impact on future medical care.\n\nExclusion Criteria:\n\n1. Patients who have received more than one line of therapy (induction, consolidation, ASCT, maintenance is considered single line therapy for the purpose of this study, also discontinuation of 1 maintenance regimen due to toxicity and start of another is considered single line therapy for the purpose of this study) or patients who have not completer two years of maintenance therapy, unless maintenance was discontinued voluntarily and the patient has achieved sustainable MRD negative remission..\n2. Patients with plasma cell disorders other than MM: lymphoplasmacytic lymphoma\u002FWaldenstrom macroglobulinemia, AL amyloidosis, POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes), etc…\n3. Prior organ transplant or condition requiring immunosuppressive therapy.\n4. Prior allogenic haematopoietic cell transplant\n5. Treatment with any investigational therapy that does not include maintenance as a part of the treatment strategy.\n6. Unable to sign an informed consent form.",{"count":163,"type":22},70,[97],"An interventional, non-randomised study to assess the risk of progression after discontinuation of maintenance therapy in sustained MRD negative complete remission by flow cytometry MM patients without high-risk features who have completed at least two years of maintenance therapy or who have discontinued maintenance due to side effects. The primary endpoint is to assess the rates of sustained MRD negativity by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.",[167,168,169],"Multiple Myeloma","Cancer","Hematologic Cancer",[167,168],{"date":131,"type":37},{"date":173,"type":37},"2023-08-28",{"date":175,"type":22},"2028-07",{"name":43,"class":44},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":16,"sex":17,"minAge":123,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":95,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":45},"100625237","the-satiety-control-optimization-by-nutritional-enhancement-study-100625237","NCT07420023","The Satiety Control Optimization by Nutritional Enhancement Study","Characterization of the Impact of Dietary Fibre Interactions in Food Products on Postprandial Glycaemic Response, Satiety, and Microbiome Composition and Function","SCONE","Inclusion Criteria:\n\n* Be willing and able to give written informed consent.\n* Be between 18 and 45 years of age.\n* Have a BMI of =25\\\u003C30kg\u002Fm2(overweight).\n* Have a waist circumference of \\>94cm for a male, \\>80cm for a female (increased risk of metabolic syndrome).\n* Have had a stable body weight (\\\u003C5% change over the past three months).\n* Be in general good health as determined by the investigator through interview and vital signs (blood pressure, pulse, temperature). Systolic blood pressure less than 160mm Hg and diastolic blood pressure less than 100 mm Hg (defined as Hypertension stage 2).\n* Be willing to avoid consuming dietary supplements (at the discretion of the investigator), prebiotics, probiotics, or fibre-rich supplements within four weeks before the baseline visit, and until the end of the study.\n* Be willing to avoid vigorous physical activities on the interventional days (defined as any physical activity that is planned to achieve a fitness goal).\n* Be willing to consume the investigational food products and menu plan daily for the duration of the study.\n\nExclusion Criteria:\n\n* Pregnant, lactating, or post-menopausal women, or women who are planning to become pregnant over the study period.\n* Have had antibiotic treatment within three months before baseline.\n* Are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of study results; to include anti-inflammatory drugs, H2 blockers, antacids, proton pump inhibitors, anti-hypertensive medications, corticosteroids, laxatives, enemas, antibiotics, anti-coagulants, and immunosuppressant medication. Participants should have a wash-out period of at least two weeks for each of these medications except for antibiotics, which should not have been taken in the previous three months. Participants taking proton pump inhibitors and medications for chronic conditions (e.g., anti-hypertensive medication) will be allowed into the study if the dose has been stable for at least two months before the study baseline visit.\n* Have a history or indication of drug and\u002For alcohol abuse at the time of enrolment.\n* Have a habitual alcohol consumption of \\>2 alcoholic beverages\u002Fday (\\>28g ethanol daily).\n* Follow a vegetarian or vegan diet.\n* Have a typical fibre intake of \\>30g per day.\n* Have experienced major dietary changes within three months before the study baseline.\n* Plan major lifestyle changes (diet, physical activity, or travel) during the study period.\n* Have a clinically diagnosed eating disorder.\n* Have a food allergy or intolerance that would preclude study product intake (for example, eggs, gluten, nuts, milk, or any other food allergy or intolerance).\n* Have an active gastrointestinal disorder or previous gastrointestinal surgery.\n* Have a significant active and medically-diagnosed acute or chronic co-existing illness including: metabolic, psychiatric, cardiovascular, endocrinological, immunological condition, gastrointestinal disease or any other condition which contraindicates, in the investigator's judgement, entry to the study (such as, diarrhoea, Crohn's disease, ulcerative colitis, IBS, diverticulosis, stomach or duodenal ulcers, hepatitis A\u002FB\u002FC, HIV, cancer, diabetes etc) or a significant history of such diseases.\n* Are severely immunocompromised (e.g., HIV positive, transplant patient, on anti-rejection medications, on a steroid for \\>30 days, or chemotherapy or radiotherapy within the last 12 months).\n* Have a malignant disease or concomitant end-stage organ disease.\n* Have symptomatic respiratory or cardiac illness.\n* Experience alarm features such as sudden weight loss, rectal bleeding, a recent change in bowel habits, or significant abdominal pain within three months before baseline.\n* Individuals who, in the opinion of the investigator, are poor attendees or unlikely for any reason to be able to comply with the study protocol.\n* Are receiving treatment involving experimental drugs.\n* If the participant has been in a recent experimental trial, these must have been completed not less than 30 days before this study.\n* Individuals who regularly undertake rigorous exercise.\n* Individuals who smoke or vape.","45 Years",{"count":187,"type":22},24,[97],"High-glycaemic foods contribute to elevated risk of obesity, type 2 diabetes, and cardiometabolic disease. Replacing digestible carbohydrates with dietary fibres is known to reduce postprandial glycaemic excursions, enhance satiety, and support beneficial microbial fermentation. However, limited evidence exists on how interactions between different isolated fibres within a processed food matrix may modulate these responses, particularly when such interactions could recreate structural features of intrinsic plant fibre networks that naturally restrict starch accessibility and alter fermentation dynamics.\n\nThis randomized, single-blinded, placebo-controlled crossover trial will investigate how isolated dietary fibres, alone and in combination, influence metabolic and microbial responses when incorporated into a commonly consumed cereal-based food (scone). Overweight but otherwise healthy adults (BMI 25-\\\u003C30 kg\u002Fm²) will consume seven fibre-enriched scone formulations across two consecutive mornings per intervention phase. Outcomes include postprandial glycaemic response measured via continuous glucose monitoring (primary outcome), perceived satiety and energy intake, gastrointestinal symptoms, fermentation dynamics via breath hydrogen and methane, and gut microbiota composition assessed through 16S rRNA sequencing. This study will generate novel insights into potential synergistic interactions between isolated fibres within a food matrix and their consequences for glycaemic control, satiety, microbial fermentation, and community. Findings will inform next-generation food design strategies aimed at replicating complex intrinsic fibre structures to enhance the health impact of processed foods.",[191],"Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease",[193,194,195,196,197,198],"Dietary fibers","metabolic diseases","blood glucose","satiety","fermentation","food matrix","2026-02-11",{"date":201,"type":37},"2026-02-19",{"date":203,"type":37},"2025-08-18",{"date":205,"type":22},"2026-05",{"name":43,"class":44},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":16,"sex":17,"minAge":123,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":95,"phases":218,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":45},"100621909","improving-adhd-symptoms-and-quality-of-life-through-diet-100621909","NCT07376746","Improving ADHD Symptoms and Quality of Life Through Diet","Improving ADHD Core Symptoms and Individual Quality of Life With Dietary APproaches Through Microbiota-Gut-Brain Signalling","ADAPT","ADHD Group Inclusion Criteria:\n\n1. Be able to give written informed consent\n2. Should be stable for 4 weeks on psychopharmacological medication or without medication\n3. Should have an established diagnosis of ADHD or ADD as the main mental disorder diagnosis. This will be validated by the ADHD diagnostic criteria after DSM-5, with the DIVA interview.\n4. Aged 18-50 years\n5. Fluency in English language\n\nControl Group Inclusion Criteria\n\n1. Be able to give written informed consent\n2. Should be stable for 4 weeks on any medication for physical health or without medication\n3. Should not currently taking psychopharmacological medicine or discontinued psychopharmacological medicine in the past 6 months (due to relapse risk)\n4. Should NOT have an established diagnosis or clinical symptoms of ADHD or ADD. This will be validated using with the ASRS-6 (\\\u003C 4)\n5. Should not have a diagnosis of ASD as indicated by self-report.\n6. Not have current, or in the past 2 years, symptoms or diagnosis of a depressive disorder, bipolar spectrum disorder, OCD, PTSD, generalised anxiety disorder, severe alcohol or illegal drug dependency, psychotic disorder, anorexia nervosa, and bulimia nervosa\n7. Not have current symptoms or diagnosis of a panic disorder or social anxiety disorder that is not currently being treated by a psychotherapist or other mental health care professional\n8. Aged 18-50 years\n9. Fluency in English language\n\nADHD and Control Group Exclusion criteria:\n\n1. Current severe depressive (PHQ-9\\>15), manic or psychotic episode, acute suicidality or suicide attempt in the past 3 months, current severe alcohol and illegal drug dependency as determined by the MINI Psychiatric Interview or clinical diagnosis.\n2. Pregnant, breastfeeding, or planning to be pregnant.\n3. Habitual fibre intake exceeding 25g\u002Fday.\n4. Allergy to intervention foods.\n5. Allergy to local anaesthesia (only if opting for the skin punch).\n6. Taking anticoagulant medication or have coagulation disorder like haemophilia (only if opting for the skin punch).\n7. Have a BMI below 18.5 kg\u002Fm2.\n8. Current diagnosis or symptoms of anorexia nervosa or bulimia nervosa, as determined by clinical diagnosis or on the MINI.\n9. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic) or any condition which contraindicates, in the investigator's judgement, entry to the study.\n10. Taking antibiotics in the past month (washout period of 1 month is required).\n11. Taking medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include anti-inflammatory drugs, corticosteroids, laxatives, enemas, anti-coagulants, and over-the counter non-steroidal analgesics. Participants should have a wash-out period of one month.\n12. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.\n13. Participants receiving treatment involving experimental drugs. Washout period of one month is required.\n14. Current prebiotic or probiotic supplement use (a wash-out period of 4 weeks after cessation will allow entry to the study).\n15. Previous participation in the Diet Study (APC150)\n16. Uncorrected vision.\n17. A history of any other condition affecting cognitive function (besides ADHD or ASD for ADHD group participants).\n\nThe specific exclusion criteria for electroencephalography (EEG) recording for both the ADHD and Control groups are as follows:\n\n1. Left-handedness,\n2. Non-removable medical devices such as pacemakers, hearing aids, cochlear implants, or deep brain stimulators,\n3. Hairstyles that prevent access to the scalp, and\n4. Skin conditions on the scalp.\n\nParticipants who meet these exclusion criteria for the EEG portion of the study will still be included in the overall study but will not undergo EEG recording and will instead complete neurocognitive tasks outside of EEG recording.","50 Years",{"count":217,"type":22},200,[97],"The goal of this randomised controlled trial is to evaluate whether a specific dietary intervention can reduce core symptoms of Attention-Deficit\u002FHyperactivity Disorder (ADHD) in adults aged 18 to 50 years. The study also aims to understand how changes in diet may influence quality of life, neurocognitive function, and gut-brain signaling through the microbiota.\n\nThe main questions it aims to answer are:\n\n1. Does a high-fiber, fermented food-based diet reduce ADHD core symptoms over a 12-week period, as measured by the Conners' Adult ADHD Rating Scale (CAARS)?\n2. Does the diet improve neurocognitive function, mood, food reward, individual goals, and other quality-of-life outcomes?\n3. How does the diet affect gut microbial composition, inflammation, and stress-related biomarkers?\n4. Is the diet well-accepted and feasible to follow?\n\nResearchers will compare a combination intervention diet (high in fiber and fermented foods) to a control diet based on general healthy eating guidelines to assess differences in symptom improvement and biological outcomes.\n\nParticipants will:\n\n1. Complete six study visits over a 24-week period (screening, baseline, weeks 4, 8, 12, and optional follow-up at week 24).\n2. Be randomly assigned to one of two dietary groups after baseline assessments.\n3. Provide stool, saliva, urine, and blood samples at multiple timepoints.\n4. Undergo cognitive testing and EEG recording to assess brain function.\n5. Wear a wristband to track sleep and activity patterns.\n6. Use a nutrition app to log dietary intake and receive weekly dietary support.\n7. Complete validated questionnaires on ADHD symptoms, mood, eating behavior, gastrointestinal health, sleep, and lifestyle factors. Feasibility and acceptability of following the diet will also be self-reported.\n\nThis study includes both adults diagnosed with ADHD and matched controls without a psychiatric condition to better understand the mechanisms and potential differential responses to dietary intervention.",[221],"ADHD",[223,221,224,225,226],"Psychobiotic diet","Fermented foods","Gut-Brain Axis","Dietary fibre","2026-02-09",{"date":229,"type":37},"2026-02-12",{"date":231,"type":22},"2026-02",{"date":233,"type":22},"2028-05",{"name":43,"class":44},{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":95,"phases":243,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":45},"100596483","peng-block-continuous-infusion-vs-programmed-intermittent-bolus-in-neck-of-femur-fracture-100596483","NCT07046052","PENG Block: Continuous Infusion vs. Programmed Intermittent Bolus in Neck of Femur Fracture","A Double Blind Randomised Controlled Trial Comparing Continuous Infusion vs. Programmed Intermittent Bolus Via a Pericapsular Nerve Group (PENG) Catheter for Post Operative Fractured Neck of Femur Analgesia","Inclusion Criteria:\n\n* English-speaking\n* over the age of 18 years\n* hemiarthroplasty for fractured neck of femur\n* able to provide written consent.\n\nExclusion Criteria:\n\n* under 50kg body weight.\n* unable to provide consent due to incapacity\n* pregnant women\n* vulnerable adults under state guardianship\n* Patients with pre-existing chronic pain disorders or with a history of long-term opioid use\n* those with contraindications to a peripheral nerve block such as local site infection, allergy to local anaesthetic or those who are coagulopathic",{"count":21,"type":22},[97],"Pericapsular Nerve Group Block (PENG) is an effective regional anaesthesia modality in providing analgesia following neck of femur fracture. Continuous PENG techniques, using indwelling catheters and infusions of local anaesthetic, facilitate the continuation of analgesia for a number of days following hip fracture surgery. It is unclear from the published literature whether an optimal strategy of local anaesthetic delivery has been characterized.\n\nSimilar doses of local anaesthetic agents can be administered by either continuous infusion or timed intermittent bolus. It is unclear whether one dosing strategy is superior to the other in the context of hip fracture analgesia. The study aims to evaluate the clinical efficacy of both dosing strategies in patients undergoing hip fracture surgery.",[246,247],"Hip Fracture","Analgesia Post Fracture",[249,250,251,252,253,254,255],"hip fracture","regional anaesthesia","analgesia","peng block","continuous infusion","programmed intermittent bolus","randomised controlled trial","2025-06-22",{"date":258,"type":37},"2025-07-01",{"date":260,"type":37},"2024-03-28",{"date":262,"type":22},"2026-01-07",{"name":43,"class":44},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":271,"enrollmentInfo":272,"targetDuration":4,"studyType":95,"phases":273,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},"100572161","a-probiotic-strategy-for-antipsychotic-induced-metabolic-dysfunction-100572161","NCT06729671","A Probiotic Strategy for Antipsychotic-induced Metabolic Dysfunction","MetaboMicrobe","Inclusion Criteria:\n\n* 8.1 Inclusion Criteria To be considered eligible for enrolment into the study, subjects must;\n\n  1. Aged between 18-65 years old including women of child-bearing age\n  2. Having a diagnosis of affective or non-affective functional psychosis defined according to ICD-10 criteria for psychosis (codes F20-30 \\& F32.3)\n  3. Patients who are able to and have given written informed consent\n  4. Patients who are willing to provide blood samples\n  5. Patients who are willing to provide saliva (cortisol) and faecal microbiome samples\n  6. Considering the nature of the study participants, a broad spectrum of concomitant medication will be permissible. Psychotropic meds, including antidepressants, mood stabilisers (lithium, valproate, carbamazepine), hypnotics and benzodiazapines, will be allowed as to not limit recruitment of this type of study participant.\n\nExclusion Criteria:\n\n1. Intravenous drug use\n2. Diagnosis of substance dependence in the past 3 months\n3. Pregnancy or planning a pregnancy\n4. Antibiotic use in the past 30 days\n5. Steroid use in the past 30 days\n6. Use of anti-coagulants, anti-inflammatory drugs, over-the counter non-steroidal anti-inflammatories (NSAIDS) and analgesics. Subjects should have a wash-out period of 4 weeks.\n7. Patients suffering from any clinically significant or unstable medical condition, including congestive heart failure, coeliac disease, or an immunodeficiency syndrome.\n8. Pre or probiotic supplements within the past 30 days.","65 Years",{"count":163,"type":22},[97],"Antipsychotic drugs are used to treat a range of psychiatric disorders including schizophrenia, bipolar disorders, and psychotic depression. Most antipsychotics are associated with significant weight gain and metabolic disturbances, which increase the risks for other diseases (obesity, diabetes, coronary diseases, etc.) and negatively impact medication adherence and quality of life. Evidence has shown that Olanzapine, for example, increases appetite, food intake, and food reward and modulates the gut microbiota. The gut microbiota can modulate adiposity, metabolism and immune-endocrine signals that impact host's energy balance and feeding behaviour. This, together with the fact that antipsychotic-induced remodelling of the gut microbiota has been associated with weight gain, suggests that microbiota-targeted interventions could help to alleviate or prevent the distressing side-effects of antipsychotic medications. The investigators have previously published promising data demonstrating anti-obesity effects of a novel Bifidobacterium longum APC1472, in a mouse model of obesity and in an overweight\u002Fobese population of humans, reducing levels of glucose and normalizing ghrelin levels. Because atypical antipsychotic medications are often used in people experiencing psychosis and the mechanisms of antipsychotic-induced weight gain and metabolic dysfunction have been suggested to include glucose intolerance (hyperglycaemia) and aberrant ghrelin signalling, the investigators propose to assess if adjunct supplementation of Bifidobacterium longum APC1472 can attenuate weight gain and metabolic side-effects associated with the use of atypical antipsychotic medication in people with non- affective psychosis. The investigators propose an exploratory patient-oriented research study, to assess the potential of adjunct Bifidobacterium longum APC1472 supplementation in individuals with psychosis receiving antipsychotic treatment, to ameliorate the liability to gain weight and\u002For normalize metabolic disturbances. Findings from this study will support clinical decision-making, increasing patient choice, and increase medication adherence, which will ultimately improve health and quality of life, and overall wellbeing of individuals as they pass through normal life stages.",[276],"Psychosis",[278,279,280],"microbiota","antipsychotic","weight gain","2024-12-09",{"date":283,"type":37},"2024-12-11",{"date":285,"type":37},"2024-05-16",{"date":287,"type":22},"2026-11-30",{"name":43,"class":44},2,{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":298,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":317},"100570589","ai-driven-narrow-band-imaging-score-for-disease-assessment-and-outcome-prediction-in-ulcerative-colitis-100570589","NCT06709209","AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis","A Novel Simplified Endoscopic Score aiMed at Evaluating Ulcerative cOlitis Activity Through TXI, RDI and NBI Vascular Assessment and at prEdicting Clinical Outcome and Its Applicability in an arTificial Intelligence System: the MONET Study","MONET","Inclusion Criteria:\n\n* Adult patients aged 18 to 75 years old\n* Established diagnosis of UC (for at least six months in duration), independently from their active treatment\n* Undergoing endoscopy for disease activity assessment or cancer surveillance.\n\nExclusion Criteria:\n\n* Contraindications to endoscopy (including toxic megacolon) and biopsies (including severe coagulopathy\u002Fthrombocytopenia)\n* Poor bowel preparation (defined as total BBPS \\\u003C6 or BBPS \\\u003C2 in observed segment for sigmoidoscopy)\n* Significant co-morbidities limiting life expectancy and conferring high risk of endoscopy\n* Pregnant and breast-feeding subjects\n* Inability to provide informed consent\n* If the participant has been in a recent experimental trial, these must have been completed not less than thirty days prior to this study","75 Years",{"count":94,"type":22},"This international multicentre prospective study aims to develop a new simple score using enhanced endoscopic techniques which focus on the vascular features of the colon and reliably distinguish between a quiescent and a mild inflammation in ulcerative colitis (UC). The diagnostic performance of the new score in defining disease activity\u002Fremission compared to existing endoscopic and histological scores and predict long-term clinical outcomes will be evaluated. The study also aims to adapt current artificial intelligence (AI) algorithms for enhanced endoscopic techniques to improve standardization in UC disease assessment and outcome prediction.",[302],"Ulcerative Colitis (UC)",[304,305,306,307,308],"Ulcerative Colitis","Virtual Chromoendoscopy","Artificial Intelligence","Disease Assessment","Outcome Prediction","2024-11-28",{"date":311,"type":37},"2024-12-03",{"date":313,"type":37},"2024-11-04",{"date":315,"type":22},"2027-09-30",{"name":43,"class":44},11,{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":95,"phases":329,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":45},"100546711","the-effects-of-exercise-on-gut-bacteria-mood-and-cognition-in-depression-100546711","NCT06398496","The Effects of Exercise on Gut Bacteria, Mood and Cognition in Depression","Investigating the Effects of an Exercise Intervention on Gut Bacteria, Mood and Cognition in Individuals With Major Depressive Disorder","Move4Mood","Inclusion Criteria:\n\n* Be able to give written informed consent.\n* Be between 18 and 59 years of age.\n* Be in generally good health as determined by the investigator (excluding Major Depressive Disorder diagnosis).\n* Community dwelling with a current diagnosis of Major Depressive Disorder, and current depression episode\u002Fsymptoms as determined via Beck's depression inventory-II (score 13-31).\n\nExclusion Criteria:\n\n* Change of pharmacological therapy less than 2 weeks prior to beginning of study (including beginning pharmacological treatment).\n* Have a significant acute or chronic coexisting illness \\[cardiovascular, gastrointestinal (GI) \\[including functional GI disorders, inflammatory bowel disease, coeliac disease\\], immunological, psychiatric \\[to include formal\u002Fclinical diagnosis or as determined via participant self-report i.e., bipolar spectrum disorder, schizophrenia, or psychosis, but not anxiety disorder\\], neurodevelopmental or neurodegenerative disorders, metabolic disorders \\[to include type I or II diabetes\\], or any condition which contraindicates, in the investigators judgement, entry to the study (including conditions which may prevent an individual from safely participating in low-to-moderate exercise intensities (57-76% heart rate max \\[HRmax\\], rating of perceived exertion \\[RPE\\]:9-13 (13))-i.e., cardiorespiratory disease\\[s\\]).\n* Have a malignant disease or any concomitant end-stage organ disease.\n* Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results; to include anti- inflammatory drugs, corticosteroids, laxatives, enemas, proton-pump inhibitors, antibiotics, or probiotics (within 1 month of starting study), anti-coagulants, thrombocyte-aggregation blocking medication(s) and over-the counter non-steroidal analgesics. Participants should have a wash-out period of four-weeks of the above-mentioned medication to be eligible for participation.\n* Individuals who are considered to be poor attendees, in the opinion of the investigator, or unlikely for any reason to be able to comply with the trial.\n* Participants must not be currently receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.\n* Are meeting the national physical activity guidelines (16) (i.e., at least 30 minutes a day of moderate intensity activity, five days a week (or 150 minutes a week), specifically in relation to structured aerobic exercise, as assessed via the international physical activity questionnaire (IPAQ). NB: if guidelines are met from occupational or incidental physical activity, individuals would not meet exclusion criteria.\n* Current perimenopause, menopause, or post-menopause, in the case of females.\n* Females who are pregnant, planning a pregnancy within duration of the study intervention period, or currently lactating.\n* Participants who are not fluent in English or English is not first language.\n* Are colour blind.\n* Have dyslexia or dyscalculia.\n* Are a current habitual daily smoker.\n* Regular, illegal drug use.\n* Alcohol abuse disorder.\n* Acute suicidality or suicide attempt in the past 6 months.\n* Current eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder).","59 Years",{"count":328,"type":22},40,[97],"This study aims to investigate the effects of a 12-week aerobic (cardio) exercise intervention in people with Major Depressive Disorder.\n\nMeasurements taken before, during, and following the 12-week intervention will include assessments of cognition, cardiorespiratory fitness, stress, mood and emotion, and gut bacteria.",[332],"Depressive Disorder, Major",[334,335,336,337],"gut bacteria","exercise","cardiorespiratory fitness","negative biases","2024-11-05",{"date":340,"type":37},"2024-11-08",{"date":342,"type":37},"2024-02-14",{"date":344,"type":22},"2026-07",{"name":43,"class":44},{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":215,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":45},"100510830","the-relationship-between-diet-cognition-stress-and-the-gut-microbiota-100510830","NCT05931536","The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota","The Relationship Between Diet, Cognition, Stress, and the Gut Microbiota: A Cross-sectional Study in Healthy Adults","NMB","Inclusion Criteria:\n\n* Be able to give written informed consent.\n* Be between 18 and 50 years of age.\n* Have a body mass index (BMI) between 18.5-29.9 Kg\u002Fm2.\n* Be in generally good health as determined by the investigator.\n\nExclusion Criteria:\n\n* Are less than 18 and greater than 50 years of age.\n* Have a BMI below 18.5 or above 29.9 Kg\u002Fm2.\n* Have a significant acute or chronic coexisting illness \\[cardiovascular, gastrointestinal (GI) \\[to include functional GI disorders, inflammatory bowel disease, coeliac disease, lactose intolerance, food allergies\\], immunological, psychiatric \\[to include formal or as determined by MINI Psychiatric interview, diagnosis of current major depression, anxiety disorder, bipolar spectrum disorder, schizophrenia, other DSM-IV Axis I disorder\\], neurodevelopmental disorders, immunological, metabolic disorders \\[to include type I or II diabetes\\], or any condition which contraindicates, in the investigators judgement, entry to the study.\n* Have a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results; all psychoactive medications \\[to include anxiolytics, antipsychotics, antidepressants, anticonvulsants, centrally acting corticosteroids, and opioid pain relievers), laxatives, enemas, antibiotics, anti-coagulants, over-the counter non-steroidal anti-inflammatories (NSAIDS). Subjects should have a wash-out period of 4 weeks.\n* Current prebiotic or probiotic supplement use (a wash-out period of 4 weeks after cessation will allow entry to the study).\n* Females who are peri-menopausal, menopausal or post-menopausal.\n* Females who are pregnant or planning a pregnancy, or lactating.\n* Participants who are not fluent in English.\n* Are colour blind.\n* Have dyslexia or dyscalculia.\n* Are a current habitual daily smoker.\n* Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.\n* Subjects receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.\n* Have a malignant disease or any concomitant end-stage organ disease.\n* Have completed a study in our laboratory in the past 4 years.",{"count":355,"type":22},350,"This study aims to investigate the relationship between diet and the microbiota-gut-brain axis.",[358],"Healthy",[360,361,362,363,226],"Microbiota-gut-brain axis","Diet","Cognition","Stress","2024-09-20",{"date":366,"type":37},"2024-09-24",{"date":368,"type":37},"2022-07-14",{"date":370,"type":22},"2025-07-14",{"name":43,"class":44},{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":17,"minAge":379,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":395},"100539113","environmental-influence-on-mental-illness-via-modifications-of-genomes-and-metabolomes-in-adolescents-with-autism-100539113","NCT06299618","Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism","ENIGMA-I","Inclusion Criteria:\n\n* Autistic Adolescents\n* Must be able to interact verbally\n* Parental consent and participants must be able and willing to give written informed assent and to comply with the requirements of the study protocol\n* Must be willing to return for all study visits and wear the study device at home\n* Must have access to and be able to operate a smartphone.\n\nExclusion Criteria:\n\n* Adolescents with severe motor impairments or schizophrenia\n* Complex medical conditions, which would interfere with ability to take part in the study visits or outcomes.\n* Intellectual disability, not capable to attend mainstream school","11 Years","15 Years",{"count":382,"type":22},400,"The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism.",[385,386],"Autism","Autism Spectrum Disorder","2024-08-13",{"date":389,"type":37},"2024-08-14",{"date":391,"type":22},"2024-09",{"date":393,"type":22},"2025-12",{"name":43,"class":44},3,{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":298,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":406,"conditions":407,"keywords":409,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":423},"100554916","ai-enabled-endoscopic-prediction-of-post-operative-recurrence-in-crohns-disease-100554916","NCT06505304","AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease","Endoscopic Multimodal Assessment Using Advanced Imaging Integrated AI to Predict Recurrence in pOSt-oPerativE CRohn's Disease - PROSPER Study","PROSPER","Inclusion Criteria:\n\n* Patients aged between 18 years and 75 years.\n* Established diagnosis of CD at least six months prior to study.\n* Patients who have undergone intestinal resection within 3 months before study entry or have surgery planned.\n\nExclusion Criteria:\n\n* Inability to provide consent.\n* Presence of serious co-morbidities (clinical contraindication).\n* Presence of ostomy.\n* Pregnancy or breastfeeding.\n* Contraindication for colonoscopy or biopsies.\n* Boston Bowel Preparation Scale Score \\\u003C2 in the rectum plus left-sided colon.\n\nExclusion criteria for pCLE only:\n\n* Allergy to nuts or shellfish.\n* Severe or uncontrolled asthma.\n* Use of beta blockers.\n* Previous history of reaction to fluorescein.\n\nPatients excluded from pCLE can still enter the study and undergo only standard-of-care endoscopy.",{"count":405,"type":22},225,"This is a multicentre prospective international observational study. This study aims to introduce a novel multidimensional approach to precision imaging, enabling the identification and stratification of high-risk patients who can potentially benefit from early treatments to halt the progression of Crohn's disease (CD). The investigators will develop a novel endoscopic assessment system using endoscopic enhanced imaging (EEI) to evaluate early post-surgical changes and predict post-operative CD recurrence (POCr). By integrating with immune marker profiling, clinical data, and AI assessment of EEI and histology, the investigators further plan to improve risk stratification and reduce interobserver variability.",[408],"Crohn Disease",[410,306,305,411,412,413,414],"Crohn's disease","Confocal laser endomicroscopy","OMIC","Machine Learning","Post-operative recurrence","2024-07-16",{"date":417,"type":37},"2024-07-18",{"date":419,"type":37},"2024-05-01",{"date":421,"type":22},"2026-05-31",{"name":43,"class":44},15,{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":352,"eligibilityCriteria":430,"healthyVolunteers":16,"sex":17,"minAge":123,"maxAge":215,"enrollmentInfo":431,"targetDuration":4,"studyType":95,"phases":432,"briefSummary":433,"conditions":434,"keywords":435,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":439,"completionDateStruct":440,"leadSponsor":441,"locationsCount":45},"100510832","the-impact-of-diet-on-the-gut-microbiota-brain-axis-100510832","NCT05931562","The Impact of Diet on the Gut-Microbiota-Brain Axis","An Interventional Study on the Association Between Diet, Cognitive Function, Stress and the Gut Microbiota in Healthy Volunteers.","Inclusion Criteria:\n\n* Be able to give written informed consent.\n* Be between 18 and 50 years of age.\n* Have a body mass index (BMI) between 18.5-29.9 Kg\u002Fm2.\n* Be in generally good health as determined by the investigator.\n\nExclusion Criteria:\n\n* Are less than 18 and greater than 50 years of age.\n* Have a BMI below 18.5 or above 29.9 Kg\u002Fm2.\n* Have a significant acute or chronic coexisting illness \\[cardiovascular, gastrointestinal (GI) \\[to include functional GI disorders, inflammatory bowel disease, coeliac disease, lactose intolerance, food allergies\\], immunological, psychiatric \\[to include formal or as determined by MINI Psychiatric interview, diagnosis of current major depression, anxiety disorder, bipolar spectrum disorder, schizophrenia, other DSM-IV Axis I disorder\\], neurodevelopmental disorders, immunological, metabolic disorders \\[to include type I or II diabetes\\], or any condition which contraindicates, in the investigators judgement, entry to the study,\n* Have a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results; all psychoactive medications \\[to include anxiolytics, antipsychotics, antidepressants, anticonvulsants, centrally acting corticosteroids, and opioid pain relievers), laxatives, enemas, antibiotics, anti-coagulants, over-the counter non-steroidal anti-inflammatories (NSAIDS). Subjects should have a wash-out period of 4 weeks.\n* Current prebiotic or probiotic supplement use (a wash-out period of 4 weeks after cessation will allow entry to the study).\n* Females who are peri-menopausal, menopausal or post-menopausal.\n* Females who are pregnant or planning a pregnancy, or lactating.\n* Participants who are not fluent in English.\n* Are colour blind.\n* Have dyslexia or dyscalculia.\n* Are a current habitual daily smoker.\n* Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.\n* Subjects receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.\n* Have a malignant disease or any concomitant end-stage organ disease.\n* Have completed a study in our laboratory in the past 4 years.",{"count":217,"type":22},[97],"This study aims to investigate the effects of an 8-week dietary intervention on cognitive function, stress, and the gut microbiota in healthy adults with low fibre intake.",[358],[360,361,362,363,436,224],"Dietary Fibre","2024-07-15",{"date":415,"type":37},{"date":368,"type":37},{"date":344,"type":22},{"name":43,"class":44},{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":17,"minAge":449,"maxAge":450,"enrollmentInfo":451,"targetDuration":4,"studyType":95,"phases":453,"briefSummary":454,"conditions":455,"keywords":458,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":83},"100551438","evaluating-a-targeted-selective-speech-language-and-communication-intervention-at-scale---protocol-for-the-happy-talk-cluster-randomised-controlled-trial-100551438","NCT06460090","Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial.","HappyTalk","Inclusion Criteria for pre\u002Fschools:\n\n* Those falling within the Health Services Executive Community Healthcare Organisation (CHO) area for which support has been offered.\n* Those attached to DEIS schools (Delivering Equality of Opportunity in Schools i.e., those including a high concentration of students from socioeconomically disadvantaged backgrounds)\n* Child and Family Resource centres (established in Ireland for children from disadvantaged backgrounds)\n\nExclusion Criteria:\n\n* Pre\u002Fschools outside of supported areas.\n* Schools that are not defined as DEIS schools.\n* Preschools not attached to DEIS schools.","2 Years","6 Years",{"count":452,"type":22},840,[97],"The overall aim of this clinical trial is to evaluate an at scale version of 'Happy Talk' in a large scale effectiveness study (examining inputs, outputs and outcomes) based on a sample of children from socially disadvantaged areas. Researchers will compare Happy Talk to usual care and children's allocation to the programme will be decided on randomly.\n\nThe investigators also aim to\n\n* complete a pre-trial process evaluation to inform intervention implementation - examining factors which promote parental engagement and partnership between SLTs and educators and incorporating these into SLT training and future rollouts of the programme.\n* complete a concurrent process evaluation from a realist perspective to examine how the mechanisms underpinning Happy Talk are influenced by the implementation context and therefore what would need to be considered for successful implementation across varied settings. Our SWAT is embedded in this process evaluation and addresses the Trials Methodology Research Network methodological priority questions 1 and 5 https:\u002F\u002Fpriorityresearch.ie\u002Fpriority-one-questions\u002F\n* Complete an economic evaluation in which compare the costs and benefits of Happy Talk are compared to standard pre\u002Fschool care.\n\nThe study aims to answer the following research questions:\n\nWhen implemented at scale\n\n1. Does 'Happy Talk', a targeted selective intervention focused on increasing parent and early educator responsive interaction, improve language and quality of-life (QoL) outcomes in socially disadvantaged preschool and young school-aged children?\n2. Does Happy Talk enhance responsiveness and language promoting behaviours in home and pre\u002Fschool contexts?\n3. What programme features support successful real-world application of 'Happy Talk' including factors which promote parental engagement; partnership between SLTs and educators; and fidelity of implementation?\n4. How do contextual factors influence Happy Talk implementation \u002Foutcomes?\n5. How can trials become part of routine care?\n6. Is Happy Talk cost effective compared to usual care?\n\nIntervention: The programme is informed by general systems theory and is embedded in the preschools, and homes of socially disadvantaged children with the aim of effecting change in parent and educator behaviour. There are both parent and preschool staff components to the programme.",[456,457],"Developmental Language Disorder and Language Impairment","Deprivation",[459,460,461,462,463,464],"Developmental language disorder","social disadvantage","public health","intervention","children","speech and language","2024-06-10",{"date":467,"type":37},"2024-06-14",{"date":469,"type":22},"2024-06",{"date":471,"type":22},"2027-06",{"name":43,"class":44},{"id":474,"slug":475,"hasResults":11,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":479,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":482,"conditions":483,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":493},"100509008","early-detection--intervention-of-cerebral-palsy-in-ireland-100509008","NCT05907837","Early Detection & Intervention of Cerebral Palsy in Ireland","Inclusion Criteria:\n\n* Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol.\n* All infants considered high risk for cerebral palsy and neuro-developmental impairment will be eligible, specifically including:\n\n  * All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight\n  * All encephalopathic infants\n  * Neurological risk factors (e.g., injury\u002Fmalformation on neuroimaging, persistently abnormal neurological exam)\n\nExclusion Criteria:\n\n* Death prior to discharge from the neonatal unit.","40 Weeks",{"count":481,"type":22},1500,"Cerebral palsy (CP) is the most common lifelong physical disability. It is defined as a non-progressive disorder of movement originating from neural lesions in the perinatal period, and is associated with a wide range of common comorbidities in many individuals. These include problems speaking, hearing, seeing, thinking, feeding and controlling their bladder. People with CP often have additional challenges such as behavioural and emotional issues, pain, and poor sleep. Many of these challenges respond well to intervention in early childhood, as brain plasticity is at its greatest in the first 2 years of life. However, in most clinical settings, the age for diagnosis of CP is between 24 to 29 months, after this window of neurodevelopmental opportunity.\n\nThis project will aim to improve the Early Detection of Cerebral Palsy in Ireland. This will be achieved by implementing an evidence-based approach to follow-up of High risk infants.",[60,484],"Neurodevelopmental Disorders","2023-09-28",{"date":487,"type":37},"2023-10-02",{"date":489,"type":37},"2023-07-01",{"date":491,"type":22},"2028-06-30",{"name":43,"class":44},5,""]