[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gut-dysbiosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gut-dysbiosis":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,68,113,166,201],{"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":24,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100639704","algal-lutein-against-decline-of-intellectual-nimbleness-100639704",false,"NCT07600567","Algal Lutein Against Decline of Intellectual Nimbleness","ALADIN","Inclusion Criteria:\n\n* Females\n* Age 48-60 years\n* Postmenopausal status (natural menopause, up to 5 years after menopause)\n* waist circumference ≥ 88 cm\n\nExclusion Criteria:\n\n* Diagnosis of dementia or cognitive impairment\n* Use of hormone replacement therapy within the last 6 months\n* Advanced age-related macular degeneration\n* History of major untreated neurological or psychiatric disorders (including depression, Parkinson's disease, Alzheimer's disease, psychiatric disorders, stroke within the last 3 months)\n* Presence of chronic diseases, including: diabetes mellitus (type 1 or 2), lipid disorders, cardiovascular diseases, thyroid diseases, anemia, liver diseases, gastrointestinal disorders, or cancer within the last 5 years\n* Use of anti-inflammatory medications or medications targeting lipid or carbohydrate metabolism within the last 3 months\n* Alcohol consumption \\> 100 g per week\n* Use of lutein-containing supplements",true,"FEMALE","48 Years","60 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"NA","Lutein is a xanthophyll pigment found in photosynthesizing organisms. Its beneficial effects on health, including brain function and visual performance, have been recognized for many years. However, to date, only a limited number of well-designed human intervention studies have been published regarding the effects of incorporating lutein into the daily diet (as humans are unable to synthesize lutein endogenously). Unfortunately, within the Western dietary pattern, the average daily intake of lutein is approximately 1.7 mg, whereas achieving health benefits- such as reducing the risk of age-related macular degeneration and cataract, as well as neurodegenerative diseases- requires an intake of 6 to 14 mg per day.\n\nIn light of the above, it is therefore justified to enrich the daily diet with products that are sources of lutein. Unfortunately, the consumption of dark green vegetables- the richest dietary source of lutein-remains insufficient. Lutein preparations currently available on the market are extracted from marigold or calendula flowers. However, lutein production from these raw materials requires greater water consumption and land use, which is not aligned with the principles of sustainable development. An alternative approach involves the production of lutein preparations from microalgae (from species approved as food by the European Food Safety Authority, EFSA), as the rate of lutein production from microalgae is three to six times higher than that from marigold flowers.\n\nTaking the above into account, the primary objective of this project is to evaluate the dose-response relationship in establishing the anti-aging mechanism of action of lutein derived from microalgae.\n\nAs part of the project, a six-month randomized, placebo-controlled trial is planned. The study will include 300 polish women (aged 48-60 years), after natural menopause, with visceral obesity (waist circumference ≥ 88 cm). In order to enable the inclusion of such a large study population, the research team will conduct intensified recruitment efforts for several months prior to the initiation of the dietary intervention.\n\nParticipants who meet the inclusion criteria will be randomly assigned to one of three groups: lutein supplementation at a dose of 6 mg (n = 100), lutein supplementation at a dose of 14 mg (n = 100), or placebo (n = 100). The volunteers will be instructed to take the prescribed preparation daily for 180 days. All preparations will be identical in appearance, taste, and smell.\n\nAll volunteers expressing willingness to participate in the experiment will be asked to provide written informed consent prior to enrollment in the study.\n\nThe study will be conducted in accordance with the previously calculated sample size (n = 300 postmenopausal women with visceral obesity). In order to obtain a homogeneous study population, appropriate inclusion and exclusion criteria will be applied.\n\nConducting the research in such a large and homogeneous group will enable the generation of high-quality scientific evidence identifying the dose of microalgae-derived lutein that allows for the determination of its anti-aging mechanism of action. It will also be possible to elucidate the potential role of short-chain fatty acids (SCFAs) in feces in this process, which may represent a significant novelty in this field of research.\n\nThe study will contribute to the development of new knowledge regarding the anti-aging properties of lutein derived from microalgae in populations vulnerable to cognitive impairment (postmenopausal women). However, microalgae-derived lutein may be used as a dietary supplement not only in the studied group but also in the general population.\n\nThe specific objectives are as follows:\n\n* To assess the effect of lutein derived from microalgae (at doses of 6 mg and 14 mg) on the concentration of brain-derived neurotrophic factor (BDNF), inflammatory markers, cardiometabolic parameters, fecal short-chain fatty acid (SCFA) concentrations, and cognitive function in postmenopausal women with visceral obesity.\n* To evaluate adherence to lutein supplementation recommendations (by assessing macular pigment optical density).\n* To determine whether supplementation with microalgal lutein increases fecal SCFA concentrations and whether SCFAs may act as mediators in improving inflammatory markers and cognitive function in postmenopausal women with visceral obesity.\n* To determine whether supplementation with microalgal lutein (at doses of 6 mg and 14 mg) affects changes in selected gut bacterial populations and β-glucuronidase enzymatic activity in postmenopausal women with visceral obesity.\n* To analyse the association between polymorphisms in genes related to lutein metabolism and transport in the body and the effectiveness of supplementation with this compound.\n* To identify dietary behaviour patterns associated with high exposure to bisphenol A (BPA) and the presence of inflammation in postmenopausal women with visceral obesity.",[28,29,30,31,32,33,34,35],"Menopausal Syndrome","Cognitive Decline","Obesity & Overweight","Menopause","Inflamation","Gut Dysbiosis","Bisphenol A","Cardio Vascular Disease",[37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"menopausal syndrome","cognitive decline","obesity","menopause","inflammation","dysbiosis","bisphenol A","gut microbiota","BNDF","intellectual nimbleness","beta-glucuronidase","lutein","supplementation","micro-algae","gene polimorfism","eye vision","chlorella","sustainable development","NOT_YET_RECRUITING","2026-05-13",{"date":58,"type":59},"2026-05-20","ACTUAL",{"date":61,"type":22},"2026-05-01",{"date":63,"type":22},"2027-04-30",{"name":65,"class":66},"Poznan University of Life Sciences","OTHER",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":16,"sex":75,"minAge":4,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":96,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100609268","infant-microbiota-restoration-with-maternal-microbes-100609268","NCT07212361","Infant Microbiota Restoration With Maternal Microbes","MaMi","Inclusion Criteria:\n\n* Healthy mother and healthy pregnancy\n* Singleton pregnancy,\n* Mothers who speak Finnish or Swedish\n* Mothers who are planning to breastfeed or give breastmilk by bottle to the infant\n* Infants who are expected to be healthy and who will not require BCG vaccination.\n\nExclusion Criteria:\n\n* Participants who lives further than a 2-hour drive from Meilahti, Helsinki, Finland\n* Mothers who are not planning to breastfeed or feed breastmilk by bottle to the infant\n* Mothers who are diagnosed with gestational diabetes, pre-eclampsia or who have been receiving antibiotics during the pregnancy or delivery\n* Premature infants born before the pregnancy week 37\n* Infants, who are born by urgent cesarean section or emergency cesarean section\n* Infants, who receive antibiotics during the first week of life\n* Infants, who are diagnosed with a disease, congenital anomaly or who receive less than 9 Apgar points at 5 minutes.\n* Infants, who receive BCG-vaccine","ALL","50 Years",{"count":78,"type":22},100,[25],"The goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants. The main question it aims to answer is:\n\nDo maternally derived strains of bacteria perform better than commercially available probiotic strains in restoring the gut microbiota of C-section born infants? Researchers will compare the gut microbiota of treated infants to that of untreated C-section born infants and untreated vaginally born infants to see if the bacterial treatments cause the microbiota to resemble that of vaginally born infants.\n\nParticipants will be given a bacterial product orally once daily for either one or four weeks and be asked to collect faecal, urine and saliva samples.",[82,83,33,84,85,86,87,88,89,90,91,92,93,94,95],"Infant, Newborn","Gut -Microbiota","Cesarean Delivery Affecting Newborn","Cesarean Section","Vaginal Delivery","Gastrointestinal Microbiota","Microbiota, Cesarean Section, Probiotics, Dysbiosis","Feces","Delivery, Obstetric","Microbiota","Microbiology","Humans","Pregnancy","Neonate",[97,98,99,100,101,44],"Infant","newborn","cesarean section","neonate","restore","RECRUITING","2025-09-30",{"date":105,"type":59},"2025-10-08",{"date":107,"type":59},"2025-07-17",{"date":109,"type":22},"2035-12-31",{"name":111,"class":66},"University of Helsinki",2,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":16,"sex":17,"minAge":121,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":125,"conditions":126,"keywords":139,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":67},"100607934","early-life-malnutrition-environmental-enteric-dysfunction-and-microbiome-trajectories-100607934","NCT07195006","Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories","Early Life Diarrhoea Episode(s), Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories From Birth Until 3 Years of Life ; The University of Zimbabwe Birth Cohort Study-2 (UZBCS-2)","UZBCS-2","Inclusion Criteria for Cases:\n\n* MUAC ≤23 cm in pregnancy\n* ≥18 years' old\n* At least 20 weeks' gestational age\n* Height ≥150 cm\n* Planning to be staying in the study area for the next 3 years\n* Willing to participate and comply with all study requirements and procedures.\n\nAny pregnant woman meeting the above eligible criteria regardless of HIV status who meet the above inclusion criteria will be invited to participate in the study\n\nInclusion criteria for Controls\n\n* Age, HIV status, gestational age at enrolment, and area residence matched normo-nourished peers with MUAC ≥25 - ≤35 cm\n* Haemoglobin level of ≥11g\u002FdL\n* ≥18 years' old\n* At least 20 weeks' gestational age\n* Height ≥150 cm\n* Planning to stay in the study area for the next 3 years\n\nExclusion Criteria\n\n* Acute or chronic conditions in mothers interfering with the study according to the judgment of the investigator (HIV infection is not an exclusion criterion)\n* Presence of severe mental health disorders interfering with study procedures according to the judgment of the investigator.","18 Years",{"count":123,"type":22},368,"OBSERVATIONAL","Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to also develop it. The interaction of the mother with the infant shapes the seeding and the trajectory of the infant intestinal microbiota which is crucial for development of a healthy immune system Malnutrition has been associated with intestinal inflammation, intestinal leakage and reduced calorie absorption. Early life malnutrition and environmental enteric dysfunction (EED) immunopathology remains poorly described in the context of mother-infant dyads. This is essential as malnutrition, poor water, sanitation and hygiene (WASH), including the presence of infectious diseases limit the developmental potential of the exposed infants in SSA, including Zimbabwe. In addition, maternal stress and poor mental health may also affect standard hygiene practices, including how a mother cares for her baby, potentially aggravating EED and the risk of the infant being malnourished.\n\nPrimary outcomes\n\n1. Infant malnutrition and recovery.\n2. Gut dysfunction (gut inflammation, leaky gut, malabsorption, dysbiosis)\n3. Diarrhea episodes, defined as any episode of acute diarrhoea (≥3 passages of loose stool within 24 hours as reported by the mother) occurring before the next study visit.\n\nDefinition of malnutrition outcomes to be assessed in babies born to malnourished women, is a mid- upper arm circumference (MUAC) \\\u003C23cm;\n\n* MUAC for age: Malnourished defined as those below -2 standard (SD) of the World Health Organisation (WHO) reference\n* Weight-for-age: Underweight defined as those below -2SD WHO reference\n* Weight-for-height: Wasted defined as those below -2SD WHO reference\n* Height-for-age: Stunted defined as those below -2SD WHO reference\n* Z-scores (as they are i.e. a continuous variable, taking age of infants into account)\n* A composite variable, any of malnourished, underweight, wasted or stunted.",[127,128,129,130,33,131,132,133,134,135,136,137,138],"Malnutrition Pregnancy","Malnutrition in Children","Malnutrition (Calorie)","Environmental Enteric Dysfunction","Gut Permeability, Gut Inflammation","Diarrhea Infectious","Maternal Stress","Child Mental Health","Natural Killer Cell Mediated Immunity","Mycotoxin Biomonitoring","Environmental Exposures","Cell-Mediated Immune Deficiency",[140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156],"diarrhoeal episodes","short chain fatty acids receptor agonists","intestinal inflammation, leakage and calory extraction","toxins in drinking water and food","macro- and micronutrient composition of breast milk","human anti-Gal antibodies","mitochondria health and nutrient uptake","endothelial dysfunction and oxidative stress","hormonal mediated molecular signalling mechanisms","interaction of epigenetics & socioeconomic factors","microbiota, pathobionts and oral microbiota","metagenomics","undernutrition and intestinal infections","infant mortality, morbidity within 1st 1000 days of life","low mid upper arm circumference","sleep adequacy in maternal mental health","chronic inflammation","2025-09-18",{"date":159,"type":59},"2025-09-26",{"date":161,"type":59},"2025-01-27",{"date":163,"type":22},"2032-12-31",{"name":165,"class":66},"University of Zimbabwe",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":75,"minAge":121,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":179,"conditions":180,"keywords":184,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":67},"100582429","phase-1-probiotic-supplementation-and-disease-progression-in-ckd-a-randomized-trial-100582429","NCT06863194","Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial","Effects of Probiotic Supplementation on Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease: A Randomized Controlled Trial","PRO-CKD","Inclusion Criteria:\n\n* Adults aged ≥ 18 years (both males and females).\n* Diagnosed with Chronic Kidney Disease (CKD) Stage III or IV, confirmed by eGFR.\n* Stable medical condition with no recent hospitalization for acute kidney injury or other serious illnesses.\n* Not currently on probiotic supplementation or prebiotic therapy.\n* Willing to provide informed consent and comply with the study protocol, including clinic visits and sample collection.\n\nExclusion Criteria:\n\n* CKD Stage I, II, or V, or on dialysis.\n* Currently using probiotics or prebiotics as part of their diet or treatment.\n* History of active malignancy (cancer) or undergoing chemotherapy.\n* Significant gastrointestinal disease (e.g., inflammatory bowel disease, irritable bowel syndrome, or recent GI surgery).\n* Pregnant or breastfeeding women (due to safety concerns).\n* Patients with autoimmune diseases (e.g., lupus, rheumatoid arthritis).\n* Individuals on long-term antibiotic or anti-inflammatory medication that could interfere with microbiota composition.\n* Individuals with severe behavioral or cognitive disorders that may prevent adherence to the study protocol.",{"count":175,"type":22},72,[177,178],"PHASE1","PHASE2","The goal of this clinical trial is to learn whether probiotic supplementation can slow disease progression in patients with moderate to severe chronic kidney disease (CKD). The trial will also assess the safety of probiotics in these patients.\n\nThe main questions the study aims to answer are:\n\nDoes probiotic supplementation improve kidney function by reducing serum creatinine levels and protein in urine? Does it reduce inflammation and metabolic imbalances in CKD patients? Does it affect gut microbiota composition and lower harmful toxins in the body? Is probiotic supplementation safe and well-tolerated in CKD patients?\n\nParticipants will:\n\nBe randomly assigned to receive either probiotics or a placebo for 6 months. Have clinic visits every 6 months for checkups, blood tests, and urine tests. Be monitored for any side effects and changes in kidney function. Researchers will compare the probiotic group to the placebo group to determine whether probiotics are effective in slowing CKD progression.",[181,182,33,183],"Kidney Disease, Chronic","Renal Insufficiency, Chronic","Uremic Toxins",[185,186,187,183,188,189,190,191],"Chronic Kidney Disease (CKD)","Probiotics","Gut Microbiota","Indoxyl Sulfate (IS)","Inflammation in CKD","Dysbiosis in CKD","Lactobacillus plantarum","2025-05-13",{"date":194,"type":59},"2025-05-16",{"date":196,"type":59},"2025-04-03",{"date":198,"type":22},"2025-10-20",{"name":200,"class":66},"Mansoura University",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":67},"100569884","probiotic-supplementation-during-pregnancy-in-women-with-high-risk-pregnancies-100569884","NCT06700044","Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies","Assessing the Effects of Probiotic Supplementation in Women With High-Risk Pregnancies: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Pregnant women ≥ 18 years old\n* High risk of PE (≥ 1 high-risk factor, or ≥3 moderate risk factors according to the Swedish Society of Obstetrics and Gynecology (SFOG) 2019 guidelines); or low risk of PE (no high-risk factors, or \\<3 moderate risk factors):\n\n  * High risk factors are:\n\n    * Auto-immune diseases such as SLE or anti-phospholipid syndrome\n    * Previous preeclampsia or eclampsia\n    * Previous hypertension of pregnancy with preterm birth before gestational week 34, growth restriction, intrauterine fetal death or ablatio\n    * Type 1 or 2 diabetes\n    * Duplex (or triplex) pregnancy\n    * Kidney disease\n    * Chronic hypertension\n    * IVF with egg donation\n  * Moderate risk factors are:\n\n    * Nulliparity\n    * Heredity for preeclampsia (at least one of mother, maternal grandmother, or sister)\n    * BMI\\>30\n    * Age\\>40\n    * Pregnancy interval \\>10 years\n    * Systolic blood pressure \\>130 mmHg or diastolic blood pressure \\> 80 mmHg at admission in antenatal maternity care\n    * African descent\n    * Verified obstructive sleep apnea\n* Ability to give written informed consent\n\nExclusion Criteria:\n\n* Enrollment in another clinical study\n* Use of other probiotic supplements in the last 2 weeks before baseline, or during the course of the study\n* Use of antibiotics in the last 6 weeks\n* Current treatment with metformin, progesterone, or regular medical treatment which may impact study aim (e.g. laxatives)\n* Immunosuppression\n* Diabetes mellitus (type I and type II)\n* Inflammatory bowel disease\n* Celiac disease\n* Bad obstetric history\n* Other serious conditions that might affect gut flora or capability of the subject to participate\n* Language difficulties or difficulties understanding informed consent",{"count":209,"type":22},150,[25],"Preeclampsia (PE) is a complication during pregnancy characterized by hypertension, organ damage, and inflammation, without an effective treatment. The underlying mechanisms causing the disease also remain partly unknown. In this double-blind placebo-controlled study, the effects of probiotic dietary supplement GutMagnific during pregnancy will be assessed in pregnancies with a high risk of PE as well as low risk. The hypothesis is that probiotic dietary supplement GutMagnific can prevent or reduce the inflammatory response and clinical manifestations associated with PE through counteracting imbalances in the oral and gut microbiome composition.",[213,33],"Preeclampsia",[215,216,217,218,219,220],"preeclampsia","probiotics","microbiome","lactobacillus","pregnancy","GutMagnific","2024-12-20",{"date":223,"type":59},"2024-12-27",{"date":225,"type":59},"2024-12-10",{"date":227,"type":22},"2027-12",{"name":229,"class":66},"Region Skane"]