[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biocodex\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":163},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,51,83,110,135],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100609309","probiotic-and-ginger-supplement-for-symptoms-and-quality-of-life-in-functional-dyspepsia-subtile-100609309",false,"NCT07212907","Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)","Effect of a Combination of Spore-forming Probiotics (Bacillus Coagulans MY01 and Bacillus Subtilis MY02) and Ginger Extract on Symptoms and Quality of Life in Patients With Functional Dyspepsia","SUBTILE","Inclusion Criteria:\n\n* Adults (male or female) aged ≥18 years.\n* Diagnosis of functional dyspepsia (FD) according to Rome IV criteria, with normal upper endoscopy including negative Helicobacter pylori test. Rome IV criteria define FD as the presence of one or more of the following symptoms: bothersome postprandial fullness, early satiety, epigastric pain, or epigastric burning, occurring at least 3 days per week during the last 3 months, with symptom onset at least 6 months prior to diagnosis.\n* PAGI-SYM total score \\>1 at baseline.\n* Ability to comply with study requirements and provide signed written informed consent before any study-related procedures.\n* Ability to complete the patient diary and questionnaires, in the investigator's opinion (sufficient reading and language comprehension).\n* For women of childbearing potential : Negative urine pregnancy test immediately before starting study product ; Agreement to use an approved method of contraception for the duration of the study, unless meeting criteria for menopause (≥12 months of spontaneous amenorrhea). Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, including those whose career, lifestyle, or sexual orientation normally precludes heterosexual intercourse.\n* Affiliation with a national health insurance or social security system.\n\nExclusion Criteria:\n\n* Use within 2 weeks prior to baseline of treatments that could interfere with study evaluation, including Bacillus coagulans MY01, Bacillus subtilis MY02, ginger, peppermint, or antibiotics.\n* Known allergy or hypersensitivity to any component of the investigational product.\n* Contraindication or specific warning related to the investigational product, including use of anticoagulants.\n* Use of immunosuppressive therapy within the last 3 months.\n* Use of medications affecting gastrointestinal motility or sensitivity, including opioids, GLP-1 analogs, neuroleptics, antiemetics, or anticholinergics. (Stable antidepressant therapy allowed.)\n* Significant changes in diet or physical activity within 2 weeks prior to baseline or anticipated during the study period.\n* Active somatic or psychiatric disorder that could explain dyspeptic symptoms (e.g., active cancer, inflammatory disease). Stable use of one antidepressant is allowed for psychiatric indication.\n* Active Helicobacter pylori infection.\n* Predominant symptoms of gastroesophageal reflux disease (GERD) or irritable bowel syndrome (IBS).\n* Functional diarrhea or functional constipation as defined by Rome IV criteria.\n* History of abdominal surgery within the past year, except appendectomy, cholecystectomy, inguinal hernia repair, or splenectomy.\n* Pregnant or breastfeeding women.\n* Individuals under legal guardianship or curatorship.\n* Participation in another interventional clinical trial and receipt of an investigational product within 30 days prior to baseline.\n* Any acute or chronic medical or psychiatric condition that, in the investigator's judgment, could interfere with study assessments, including but not limited to severe hepatic or renal insufficiency, immunodeficiency, or substance abuse (alcohol or drugs).\n* Any personal condition or circumstance that, in the investigator's judgment, would make full participation in the study unlikely or impossible.","ALL","18 Years",{"count":20,"type":21},198,"ESTIMATED","INTERVENTIONAL",[24],"NA","Functional dyspepsia (FD) is a frequent functional gastrointestinal disorder characterized by bothersome postprandial fullness, early satiety, epigastric pain, or burning, in the absence of any structural or metabolic cause. It significantly impairs quality of life and has limited therapeutic options, as conventional treatments such as proton pump inhibitors often show modest efficacy and may cause side effects with long-term use.\n\nThe gut and duodenal microbiota may play a role in FD. Spore-forming probiotics such as Bacillus coagulans MY01 and Bacillus subtilis MY02 have shown beneficial effects on FD symptoms in a randomized controlled trial. Ginger (Zingiber officinale) has a long history of traditional use as a gastroprotective agent and is supported by clinical and non-clinical data for improving gastric motility and related symptoms.\n\nThis study (SUBTILE, STO-253) is a prospective, interventional, multicenter trial conducted in France. It will evaluate the effect of a dietary supplement containing Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger extract (50 mg, 20% gingerols) on FD symptoms and quality of life.\n\nA total of 198 adult patients diagnosed with FD according to Rome IV criteria and with a normal upper endoscopy will be recruited in primary care and gastroenterology practices. Participants will take one capsule of the study product daily for 8 weeks.\n\nThe primary outcome is the change in the Patient Assessment of Gastrointestinal Symptom Severity (PAGI-SYM) total score between baseline and Week 8.\n\nSecondary outcomes include changes in quality of life (PAGI-QoL), treatment adherence, use of concomitant medications, evolution of lower gastrointestinal symptoms, patient and physician global impressions of change (PGI-C, CGI-I), and satisfaction (Likert scales). An exploratory objective will assess psychological impact using the Hospital Anxiety and Depression Scale (HADS).\n\nThe study includes two site visits (baseline and end of study) and one telephone follow-up at Day 28. Safety and tolerability will be monitored through active reporting of adverse events.\n\nThe trial aims to provide new evidence on the role of probiotics combined with ginger extract as a non-pharmacological strategy to improve digestive comfort and quality of life in patients with functional dyspepsia.",[27],"Functional Dyspepsia",[27,29,30,31,32,33,34,35,36,37],"Bacillus coagulans MY01","Bacillus subtilis MY02","Ginger extract","Symbiosys Stomalex","Gut microbiota","Quality of life","Gastrointestinal symptoms","Spore-forming probiotics","Epigastric Pain Syndrome","RECRUITING","2026-01-05",{"date":41,"type":42},"2026-01-07","ACTUAL",{"date":44,"type":42},"2025-12-22",{"date":46,"type":21},"2027-01",{"name":48,"class":49},"Biocodex","INDUSTRY",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100605892","phase-3-saccharomyces-boulardii-cncm-i-745-in-irritable-bowel-syndrome-100605892","NCT07168434","Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome","A Double-blind, Randomized, Placebo-controlled, Multicenter Trial Evaluating the Efficacy and Safety of Saccharomyces Boulardii CNCM I-745 in Adult Patients With Non-constipated Irritable Bowel Syndrome","BoWell Sb252","Inclusion Criteria:\n\n1. Male or female aged ≥ 18 and ≤ 65 years.\n2. Diagnosis of IBS of any subtype, except constipation predominant (IBS-C), according to Rome IV criteria.\n3. IBS-SSS total score ≥ 175 at inclusion.\n4. Able and willing to maintain their nutrition habits throughout the study participation.\n5. Able to understand and willing to comply with study requirements and to provide written informed consent.\n6. For women of childbearing potential: willing to use one or more acceptable birth control method throughout the study participation.\n\nExclusion Criteria:\n\n1. Diagnosis of IBS-C according to Rome IV criteria.\n2. Patient with more than 5 bowel movements per day on average during the screening period, according to the patient's diary (BSFS).\n3. Severe illness(es) or medical condition(s), including gastrointestinal pathologies (other than IBS): gastrointestinal ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, acute or chronic diarrhea secondary to confirmed infectious gastroenteritis, or enteral or parenteral nutrition.\n4. History of abdominal surgery (except for appendectomy, cholecystectomy, surgery for hemorrhoids or cesarian section, more than 6 months prior to inclusion).\n5. Familial colorectal cancer syndrome (Lynch, Familial Adenomatous Polyposis).\n6. Fecal transplant within 6 months prior to screening.\n7. Use of products marketed as prebiotics, probiotics or synbiotics within 2 weeks prior to screening. These products, with the exception of the investigational product, will not be allowed during the trial. Regular cheese or yogurt containing lactic acid bacteria are not an exclusion criterion.\n8. Systemic antibiotic or antimycotic treatment within 2 weeks prior to randomization. These treatments are not allowed during the study.\n9. Laxatives, antibloating agents, antidiarrheal medication, antispasmodics, within 2 weeks prior to screening. These treatments are not allowed during the study, except loperamide which can be used as rescue medication.\n10. Daily or regular non-steroidal anti-inflammatory drugs (NSAIDS) at doses above cardiovascular prophylaxis (low dose aspirin) are not allowed within 2 weeks prior to screening and throughout the study participation.\n11. Use of opioids or narcotic analgesics, including tramadol and codeine, within 6 weeks prior to screening. These treatments are not allowed during the study.\n12. Treatment with two or more antidepressant\u002Fanxiolytic\u002Fantipsychotic within 3 months prior to study entry or during the trial. Treatment with a single antidepressant or anxiolytic or antipsychotic agent before and during the trial is allowed provided that the dose is stable within 3 months prior to study entry and during the trial participation.\n13. Treatment with anticholinergics for overactive bladder such as solifenacin, darifenacin, oxybutynin, tolterodine, fesoterodin, propiverin, trospium chloride, or mirabegron, within 1 week prior to screening. These treatments are not allowed during the study.\n14. Allergy to yeast, especially Saccharomyces boulardii, or known hypersensitivity to one of the components.\n15. Patients having a central venous catheter, critically ill patients, and immunocompromised patients.\n16. Patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.\n17. Excessive alcohol consumption (\\>7 units\u002Fweek) and\u002For drug abuse.\n18. Other medical conditions or comorbidities, treatment, which in the opinion of the investigator, would interfere with study compliance or data interpretation.\n19. Presenting any significant biological or clinical anomalies that are not compatible with participation in the study according to the investigator.\n20. Participant at risk of pregnancy, pregnant or breastfeeding female.\n21. Participant under guardianship or curatorship.\n22. Participant under the protection of the Court or deprived of liberty.\n23. Participant participating in another interventional clinical trial which could interfere with the trial's results or impact the other trial's results; or within 5 half-lives of the study investigational treatment, whichever is longer.\n24. Participant whose current state of health does not allow him\u002Fher to give consent.","65 Years",{"count":61,"type":21},406,[63],"PHASE3","This is a double-blind, randomized (group assignment by chance), placebo-controlled, multicenter trial which will be conducted over a 13.5-months period The main objective of the research is to demonstrate the efficacy of Saccharomyces boulardii CNCM I-745 on global IBS symptoms, measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), in comparison to placebo after 8 weeks.\n\nSecondary efficacy objectives are to evaluate the impact of Saccharomyces boulardii CNCM I-745 on quality of life of IBS patients and on global and individual IBS symptoms, using the IBS-SSS, in comparison to placebo at regular intervals over a 3-month treatment period. This research also aims to evaluate the proportion of patients who improved ≥ 50 points on IBS-SSS and the proportion of responders according to the European Medicines Agency (EMA) definition (based on the patient's global assessment of efficacy and on abdominal pain score), after 8 weeks of treatment. Secondary safety objective is to evaluate the safety profile and tolerability of Saccharomyces boulardii CNCM I-745 capsules 500 mg\u002Fday in IBS patients in comparison to placebo",[66,67,68],"IBS (Irritable Bowel Syndrome)","IBS-D (Diarrhea-predominant)","IBS, Mixed Symptoms",[70,71,72,73],"IBS","Irritable Bowel Syndrome","Saccharomyces boulardii","Non-constipated IBS","2025-11-17",{"date":76,"type":42},"2025-11-18",{"date":78,"type":42},"2025-10-22",{"date":80,"type":21},"2026-10-11",{"name":48,"class":49},10,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":50},"100550810","phase-4-effect-of-saccharomyces-boulardii-cncm-i-745-on-gut-microbiota-in-patients-undergoing-antibiotic-therapy-in-the-context-of-erythema-migrans-early-skin-form-of-lyme-borreliosis-100550810","NCT06451913","Effect of Saccharomyces Boulardii CNCM I-745 on Gut Microbiota in Patients Undergoing Antibiotic Therapy (in the Context of Erythema Migrans (Early Skin Form of Lyme Borreliosis))","SUBLYME","Inclusion Criteria:\n\n* Adult Patients, ≥18 years old.\n* Who are prescribed antibiotic therapy (as per medical routine practices, amoxicillin 1000 mg bid for 14 days) in the context of erythema migrans (early skin form of Lyme borreliosis).\n* Able to comply with study requirements and to provide signed informed consent before any study procedure.\n* Has no condition that may interfere with the study assessments.\n* Able to fulfil in the diary stool log, according to the physician's opinion.\n* Regular defecation (frequency and stool consistency, with at least about three bowel movements a week).\n* For women of childbearing potential:\n* A negative urine pregnancy test immediately prior to starting the study treatment,\n* Agreement to comply with approved methods of contraception during the whole study: unless they meet the criteria of post-menopausal, i.e. 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, should use one or more acceptable methods of contraception that should be maintained throughout the study.\n\nExclusion Criteria:\n\n* History of hypersensitivity to the study treatments (active substance or excipients), brewer's or baker's yeast,\n* Contraindication and special warning to the study drugs according to the SmPCs,\n* History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average,\n* History of chronic or recurrent diarrhoea with spontaneous unformed bowel movements equivalent to or more often than 3 times daily,\n* Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy performed at least more than one year ago),\n* History of Clostridium difficile infection,\n* Active gastrointestinal inflammatory disease,\n* Known chronic or recurrent systemic disorder that may interfere with the study drug evaluation,\n* Immunocompromised (organtransplants, leukaemia, malignant tumours, radiotherapy, chemotherapy,prolonged high dose cortisone treatment, immunosuppressant treament) or critically ill patients (such as autoimmune disease, HIV,…), patients with a central venous catheter,\n* Severe hepatic or renal impairment,\n* Systemic antibacterial therapy during the 2 months prior to study enrollment,\n* New prescription medications during the 2 weeks prior to study enrollment,\n* Use of any drug or product that alters gut microbiota or function, such as probiotics, laxatives, antiemetics, cisapride, antisecretory or adsorbent treatments (racecadotril, smectite, activated charcoal), opiates such as loperamide, atropine and other cholinergic agents, 4 weeks prior to study enrollment and during the study,\n* Intake of antifungals within 14 days prior to study enrollment,\n* Substantial changes in eating habits within 30 days prior to receiving the first dose of IMP product, and during the study as assessed by the Investigator,\n* History or presence of drug or alcohol abuse,\n* Heavy smoker (more than 10 cigarettes per day),\n* Breast-feeding woman,\n* Patients enrolled in another interventional clinical trial where they received an investigation treatment within the past 30 days,\n* Any condition or personal circumstance that, in the opinion of the investigator, rendered the subject unlikely or unable to comply with the full study protocol",{"count":91,"type":21},120,[93],"PHASE4","The aim of this study is to assess the effect of Saccharomyces boulardii CNCM I-745 on gut microbiota in patients undergoing antibiotic therapy (in the context of erythema migrans (early skin form of Lyme borreliosis)).",[96],"Erythema Migrans of Lyme Disease",[98,99,33,100,101],"Erythema Migrans","Lyme Disease","Saccharomyces boulardii CNCM I-745","Lyme borreliosis","2025-08-21",{"date":104,"type":42},"2025-08-27",{"date":106,"type":42},"2025-07-16",{"date":108,"type":21},"2026-12",{"name":48,"class":49},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":118,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100561086","the-effect-of-mucogyne-ovule-on-wound-healing-origyne-100561086","NCT06585579","The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)","ORIGYNE (MUCO232) - the Effect of Mucogyne® Ovule on Wound Healing","ORIGYNE","Inclusion Criteria:\n\n1. Adult women who had undergone localized surgery (laser or loop electrosurgical excision procedure (LEEP) conization) for cervical or vaginal dysplasia,\n2. Is able to understand the study related information and to give a written informed consent,\n3. Has signed the informed consent form before beginning any study procedure,\n4. Has no condition that may interfere with the study assessments,\n5. Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,\n6. Is able to comply with protocol requirements and respect the conditions of the study,\n7. Affiliated to the Social Security system.\n\nExclusion Criteria:\n\n1. Previous vaginal surgery within the year preceding the inclusion in the study,\n2. Known hypersensitivity to any of the medical device ingredients,\n3. Patient with local infectious lesions in the area to be repaired.\n4. Patient who had used anti-inflammatory drugs (regular intake) or anticoagulants during the month preceding the inclusion in the study,\n5. Patient who had a history of diseases known to disturb wound healing (e.g. systemic, heart, and renal diseases, coagulation disorders, immunedeficiency, connective tissue disorders, diabetes, anemia (with hemoglobin level \\\u003C 9 g\u002Fdl) and hemophilia),\n6. Immunosuppressive treatment,\n7. Heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent\u002Fday, according to the patient and their documented records),\n8. Patients under judicial protection or under guardianship and patients deprived of freedom,\n9. Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments.","FEMALE",{"count":120,"type":21},144,[24],"This clinical investigation is a post-market clinical follow-up performed to confirm the performance and safety of the Mucogyne® ovule medical device in promoting the process of wound healing, when used in accordance with its approved labelling, in the context of local cervicovaginal surgery.",[124],"Cervicovaginitis","NOT_YET_RECRUITING","2024-09-03",{"date":128,"type":42},"2024-09-05",{"date":130,"type":21},"2024-10",{"date":132,"type":21},"2025-11",{"name":48,"class":49},3,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":142,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":4},"100551852","phase-3-evaluation-of-the-efficacy-and-safety-of-stiripentol-in-patients-6-years-and-older-with-primary-hyperoxaluria-type-1-2-or-3-100551852","NCT06465472","Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1, 2 or 3","CRYSTAL","Screening Criteria :\n\n* 1\\. Male or female patients aged ≥ 6 years at the time of consent signature\n* 2\\. Diagnosed with primary hyperoxaluria (type 1, 2 or 3) documented as per standard methods\n* 3\\. With last estimated Glomerular Filtration Rate ≥ 45 mL\u002Fmin\u002F1.73 m2\n* 4\\. Able to understand and willing to comply with study requirements and to provide written informed consent. In case of patient under the age of legal consent, the legal guardian(s) must provide informed consent and the patient should provide assent as per local and national requirements\n* 5\\. Female patients with contraception (intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, surgical sterilization of male partner, established use of oral, implantable, injectable, or transdermal hormonal methods of contraception, a double-barrier method (combination of male condom with cap, diaphragm, or sponge, in conjunction with spermicide) or true sexual abstinence\n\nInclusion Criteria:\n\n* 1\\. Diagnosed with primary hyperoxaluria disease and subtype (type 1, 2 or 3) confirmed by genetic testing\n* 2\\. Receiving optimal management of the disease through standard of care strategies (e.g., increased fluid intake, vitamin B6, potassium citrate) with or without approved target medications (e.g., lumasiran). Patients not receiving lumasiran can only be enrolled if they are not eligible for treatment with lumasiran for the specific following reasons: contraindications, previous treatment discontinued due to lack of efficacy or poor tolerability, not meeting national or regional eligibility criteria for treatment, investigator judgement\n* 3\\. With mean 24-hour urinary oxalate excretion from 2 valid 24-hour urine collections ≥ 0.70 mmol\u002F24h\u002F1.73m²\n* 4\\. With estimated Glomerular Filtration Rate ≥ 45 mL\u002Fmin\u002F1.73 m2 (Schwartz et al., 2009 in pediatric patients and CKD-EPI in adults)\n* 5\\. Pubescent and adult female patients must have a negative urine or serum pregnancy test within 60 days prior to first dose of study treatment if of childbearing potential. If the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the patient to be eligible\n* 6\\. In France, patient affiliated with or who benefits from a social security scheme\n\nExclusion Criteria:\n\n* 1\\. Any relevant change in the use of any component of the standard of care (fluid intake, vitamin B6, potassium citrate) in the 4 weeks prior to inclusion or if such change is planned to occur during the first 6 months of the study\n* 2\\. If under approved targeted medications (e.g., lumasiran), treatment should have been administered for at least 6 months, with no change in dose or regimen in the 3 months prior to inclusion or ifsuch change is planned it should not occur during the first 12 months of the study\n* 3\\. History of kidney or liver transplant\n* 4\\. Presenting any of the following liver function tests abnormalities during the screening period:\n\n  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\\> 2 × upper limit of normal (ULN)\n  2. Total bilirubin \\> 1.5 x ULN. Patients with elevated total bilirubin that is secondary to documented Gilbert's syndrome are eligible if the total bilirubin is \\\u003C 2 x ULN\n* 5\\. Recent (4 weeks before the screening visit) or planned change in eating habits\n* 6\\. Intermittent fasting planned during the 6 first months of the study period (e.g., Ramadan)\n* 7\\. Other medical conditions or comorbidities, treatment, which in the opinion of the investigator, would interfere with study compliance or data interpretation\n* 8\\. Presenting any significant biological or clinical anomalies that are not compatible with participation in the study according to the investigator\n* 9\\. History of severe allergy, asthma, skin rashes, intolerance to lactose or hypersensitivity to the study treatments\n* 10\\. Treatment affecting hepatic metabolism (i.e., cimetidine, ketoconazole, fluconazole, itraconazole, phenytoin, rifampicin, rifabutin) that is ongoing or has been taken in the month prior to the selection visit\n* 11\\. Treatment affecting the renal tubule (probenecid, β-lactam, etc.,) that is ongoing or has been taken in the two weeks prior to the start of the study\n* 12\\. Contraindications to stiripentol as defined in the applicable Investigator's Brochure (i.e. patients presenting a hypersensitivity to the active substance or any excipients)\n* 13\\. Patient at risk of pregnancy, pregnant or breastfeeding female\n* 14\\. Patient under guardianship or curatorship\n* 15\\. Patient under the protection of the Court or deprived of liberty\n* 16\\. Patient participating in another interventional clinical trial which could interfere with the trial's results or impact the other trial's results; or within the last 30 days or 5 half-lives of the study investigational treatment, whichever is longer, prior to the urinary sampling during the screening period, or are in follow-up of another clinical study prior to randomization\n* 17\\. Patient whose current state of health does not allow him\u002Fher to give consent","6 Years",{"count":144,"type":21},42,[63],"Evaluation of the efficacy and safety of stiripentol in patients 6 years and older with primary hyperoxaluria type 1, 2 or 3.",[148,149,150],"Primary Hyperoxaluria Type 1","Primary Hyperoxaluria Type 2","Primary Hyperoxaluria Type 3",[152,153,154],"Stiripentol","Primary Hyperoxaluria","Oxalate","2024-06-12",{"date":157,"type":42},"2024-06-18",{"date":159,"type":21},"2024-08",{"date":161,"type":21},"2030-08",{"name":48,"class":49},""]