[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lallemand Health Solutions\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":103},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100611867","phase-2-vaginal-detection-of-orally-delivered-probiotic-strains-in-healthy-women-100611867",false,"NCT07246161","Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women","Detection of Orally Delivered Probiotic Strains in the Vaginal Microbiome of Healthy Female Adults","VSS2","Inclusion Criteria:\n\n* Clinically healthy female between the ages of 18 and 50 years, inclusive,\n* have a regular or predictable menstrual cycle\n* Typically have regular bowel movements,\n* Willing and able to consume a probiotic supplement for 4 weeks,\n* Willing to discontinue consumption of probiotic supplement and probiotic-fortified products 2 weeks before the start of the study and throughout the study,\n* Willing to discontinue fiber supplements 2 weeks before the start of the study, and throughout the study,\n* Willing to provide 1 stool sample 4 times throughout the study,\n* Willing to provide 2 vaginal swabs 4 times throughout the study,\n* Willing to undergo vaginal pH swab measurements (with a swab) 5 times throughout the study,\n* Willing to provide 2 perineal skin swabs (skin between the vagina and the anus) 3 times throughout the study,\n* Willing to complete a pregnancy test at the screening visit.\n\nExclusion Criteria:\n\n* Menopausal women,\n* Vaginal pH \\\u003C 2 or \\> 5 measured at screening,\n\n  •. Menstruation during the sample collection times,\n* Women that are lactating, pregnant, attempting to get pregnant, or have a positive pregnancy test,\n* Use of vaginal probiotics in the last 3 months,\n* Use of local vaginal antibiotics or antifungals in the last 3 months.\n* Use of oral antibiotics or antifungals in the last month,\n* Ongoing symptoms of vaginal and\u002For urinary tract infections,\n* Current treatment for vaginal sepsis or urosepsis,\n* Currently being treated for a severe chronic disease (e.g. cancer, renal failure, chronic inflammatory digestive or gastro-intestinal disease, immunodeficiency, etc.),\n* Clinical diagnosis of a gynecological disease or condition (e.g, fibroma, endometriosis, polycystic ovarian syndrome, etc.),\n* Clinical diagnosis of secondary dysmenorrhea,\n* Intolerance, allergy or sensitivity to milk, soy, or yeast.",true,"FEMALE","18 Years","50 Years",{"count":22,"type":23},72,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","The purpose of the present study is to obtain more information on the transit of orally ingested probiotics to the vagina.",[29],"Focus is on Healthy Subjects",[31,32],"Probiotics","Women's Health","RECRUITING","2026-06-16",{"date":36,"type":37},"2026-06-18","ACTUAL",{"date":39,"type":37},"2025-10-20",{"date":41,"type":23},"2026-10",{"name":43,"class":44},"Lallemand Health Solutions","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":17,"sex":54,"minAge":20,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":45},"100576496","phase-2-exploratory-study-on-postprandial-energy-metabolism-100576496","NCT06786052","EXploratory Study on Postprandial Energy Metabolism","Efficacy of Probiotics on Postprandial Energy Metabolism of Adults With Overweight or Obesity: an EXploratory Clinical Trial","EXPEM","Inclusion Criteria:\n\n1. Man or woman;\n2. Age between 50 and 70 years old (inclusively);\n3. Postmenopausal women, i.e. with amenorrhea for more than a year with no identified cause\n4. BMI between 27 and 34.9 kg\u002Fm2 (inclusively);\n5. Stable weight in the last 3 months (+\u002F- 5% of total body weight);\n6. Waist circumference ≥ 80 cm for women, ≥ 94 cm for men;\n7. Sedentary to moderately active (less than 30 minutes of moderate physical activity, 3 times a week);\n8. Agreeing not to consume fermented or supplemented foods (including bifidus yogurts and other foods supplemented with probiotics), dietary supplements (high in fiber (prebiotics), high protein, or other food supplements that may interact with the gut microbiota or energy metabolism), laxatives and any substance that can control metabolic parameters such as weight, blood glucose or lipid metabolism during the study period (from the screening visit);\n9. Agreeing to receive probiotics or placebo supplementation randomly;\n10. Able to understand the information given, read and write in French and have signed the informed consent form;\n11. Agreeing to submit to the entire study protocol;\n12. Having fibre consumption (through diet or supplementation) of less than 30g\u002Fday;\n13. Having a freezer to store stool samples before the visit.\n\nExclusion Criteria:\n\n1. Participant with unstable medical or psychological conditions that, in the opinion of the investigator, could lead the participant to be non-compliant or uncooperative during the study or that could compromise the safety or participation in the study (according to articles L.1121-6, L.1121-8, L.1121-9 and L1122-1-2 of the Public Health Code);\n2. Presence of pathology detectable on clinical examination and medical questioning that may interfere with the study endpoints;\n3. Alcohol consumption exceeding 30g of alcohol\u002Fday (1 dose of alcoholic beverage = 10g of alcohol) or abuse or dependence on another proven drug;\n4. Tobacco consumption (or vaping equivalent) \\> to 5 cigarettes per day and inability to restrict smoking or vaping on the exploratory days provided for in the protocol;\n5. Failure to comply with the exclusion period for another study specified in the \"national volunteer file\";\n6. Adult subject to a legal protection measure (guardianship, curatorship);\n7. Person deprived of liberty by a judicial or administrative decision;\n8. Person who has exceeded the annual amount of compensation in the year for participation in research protocols;\n9. Person not affiliated to a social security system or beneficiary of a similar system;\n10. Absence of valid approved health proof(s) in the event of government measures in an exceptional epidemic situation;\n11. Person with a specific diet (vegetarian, lacto-vegetarian, vegan, high-protein, etc.);\n12. People consuming food supplements (pre or probiotics, or minerals (divalent cations such as magnesium and calcium)) regularly during the month prior to the screening visit;\n13. Blood donation within 2 months prior to the screening visit;\n14. Claustrophobic to the point that indirect calorimetry measurement cannot be done;\n15. Person with limited venous access that can make it difficult to draw blood and insert a catheter;\n16. Type 1 or 2 diabetes;\n17. Systolic blood pressure ≥140 mmHg measured during the screening visit and mean systolic blood pressure from self-measurement over 3 days ≥140 mmHg;\n18. Diastolic blood pressure≥ 90 mmHg measured during the screening visit and mean diastolic blood pressure from self-measurement over 3 days ≥90 mmHg;\n19. Treatment for hypertension or dyslipidemia;\n20. Known endocrine pathology that may interfere with carbohydrate metabolism (uncontrolled dysthyroidism, acromegaly, hypercorticism, etc.);\n21. People with gastrointestinal pathologies with an inflammatory component or associated with malabsorption;\n22. People suffering from bloody diarrhoea;\n23. Exocrine pancreatic insufficiency;\n24. People who have had intestinal or abdominal surgery (apart from appendectomy and simple hernias), bariatric surgery (gastric banding, calibrated vertical gastroplasty and sleeve gastrectomy accepted if done more than 5 years ago);\n25. Severe eating disorders (e.g., anorexia\u002Fbulimia, uncontrolled binge eating syndrome, noctophagia);\n26. Chronic kidney failure;\n27. Hepatocellular insufficiency;\n28. Immunocompromised individuals (e.g., those with AIDS, lymphoma, patients on long-term corticosteroid therapy, patients undergoing chemotherapy and allogeneic transplants);\n29. Patients with central venous catheters and post-surgical patients;\n30. Hematological, gastrointestinal, hepatic, neurological, or psychiatric clinically significant according to the investigator;\n31. Drug treatments for obesity in the last 3 months or prescribed for the duration of the study;\n32. Taking antibiotics in the month preceding the explorations (for the so-called common antibiotics of the beta-lactam family) or in the 3 months preceding the explorations according to the investigator's judgment (for other families of antibiotics) except for certain types of antibiotics, particularly local or single-dose antibiotics: antibiotic eye drops (Oflocet), topical ointments (Fucidin), single-dose treatments (Monuril), and single-dose fosfomycin;\n33. Taking antidepressants in the 2 months prior to the explorations or prescribed for the duration of the study;\n34. Daily intake of laxatives in the 3 months prior to explorations or other medications that may strongly interfere with the composition of the gut microbiota;\n35. Taking a treatment that may interfere with the study measures, according to the judgment of the co-investigating physicians of the study.","ALL","70 Years",{"count":57,"type":23},66,[26],"This exploratory, double-blinded clinical trial on 66 randomized adults aged 50 to 70 years with moderate overweight or obesity but considered metabolically healthy will consist of comparing metabolic and microbiota parameters before and after 3 months of consumption of a probiotic or a placebo.",[61,62],"Obesity and Overweight","Moderately Obese",[64,31,65],"Metabolic health","Postprandial metabolism","2026-05-26",{"date":68,"type":37},"2026-05-28",{"date":70,"type":37},"2025-04-07",{"date":72,"type":23},"2028-02",{"name":43,"class":44},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":54,"minAge":4,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":24,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100545680","phase-2-effect-of-probiotics-on-infantile-colic-symptoms-100545680","NCT06385054","Effect of Probiotics on Infantile Colic Symptoms","Effect of Probiotics on Infantile Colic Symptoms: a Randomized, Double-blind, Placebo-controlled Study (EPIC).","EPIC","Inclusion Criteria:\n\nI1. Healthy male or female. I2. Age ≤ 8 weeks old. I3. Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behavior for 3 or more hours per day, during 3 or more days in 7 days.\n\nI4. Exclusively breastfeeding and planning to breastfeed for the duration of the study.\n\nI5. With a written informed consent signed by the father and mother or legal guardian.\n\nI6. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and scheduled telephone calls.\n\nI7. At least one of the legal representatives is affiliated with a social security scheme.\n\nExclusion Criteria:\n\nE1. Birthweight \\\u003C 2500 g. E2. Gestational age \\\u003C 37 weeks. E3. Apgar score at 5 minutes \\\u003C 7. E4. Partially or fully formula fed infants except for the 4 first days after birth.\n\nE5. Stunted growth\u002Fweight loss (\\\u003C 100 g\u002Fweek from birth to last reported). E6. Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases, or gastrointestinal malformations.\n\nE7. Diagnosed or reported fever and\u002For infectious diseases, or current systemic infections, or history of congenital infections.\n\nE8. Genetic diseases and chromosomal abnormalities. E9. Metabolic diseases or pancreatic insufficiency. E10. Immunodeficiency. E11. Neurological diseases. E12. Suspected or confirmed food allergies and intolerances. E13. Mother who consumed antacid medications (proton pump inhibitor and H2 receptor antagonist) within the month before birth and intend to consume any during the trial.\n\nE14. Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening and during the trial.\n\nE15. Use of anti-colic medication at any time from birth to the moment of screening.\n\nE16. Use of probiotics and prebiotics supplements by the mother between the birth of their infant and the moment of screening and intend to consume any during the trial.\n\nE17. Currently enrolled in another clinical study or having participated in another clinical from birth to the moment of screening.\n\nE18. Whose legal representatives have psychological or linguistic incapability to sign the informed consent.\n\nE19. Impossibility to contact the legal representatives in case of emergency.","8 Weeks",{"count":84,"type":23},70,[26],"The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention.",[88],"Infantile Colic",[80,90,31,91,92,93],"Infant Colic","Crying Time","Gut Microbiota","Sleep Duration","2024-08-14",{"date":96,"type":37},"2024-08-16",{"date":98,"type":23},"2024-08",{"date":100,"type":23},"2027-02",{"name":43,"class":44},10,""]