14 completed, 4 unknown, 3 recruiting, 1 active not recruiting. 8 Not applicable, 4 Phase 3, 4 Phase 4, 3 Phase 1, 3 Phase 2.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE) Symbiosys® Stomalex (commercial name) - Functional Dyspepsia | Not applicable | Recruiting | Biocodex | 198 | 2025-12-22 | 2026-01-07 |
| Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome Saccharomyces Boulardii 250 MG, Placebo 250 mg - IBS (Irritable Bowel Syndrome), IBS-D (Diarrhea-predominant) | Phase 3 | Recruiting | Biocodex | 406 | 2025-10-22 | 2025-11-18 |
| 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)) Amoxicillin + Saccharomyces boulardii CNCM I-745, Amoxicillin + Placebo, Stool samples - Erythema Migrans of Lyme Disease | Phase 4 | Recruiting | Biocodex | 120 | 2025-07-16 | 2025-08-27 |
| Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ) Stiripentol capsule (Diacomit®), Stiripentol oral suspension (Diacomit®) - Dravet Syndrome, Epilepsy | Phase 1 | Completed | Biocodex | 24 | 2025-06-01 | 2025-09-16 |
| The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE) Mucogyne Ovule - Cervicovaginitis | Not applicable | Unknown | Biocodex | 144 | 2024-10-01 | 2024-09-05 |
| Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1, 2 or 3 Stiripentol Oral Capsule, Placebo Oral Capsule, Urine samples collect - Primary Hyperoxaluria Type 1, Primary Hyperoxaluria Type 2 | Phase 3 | Not yet recruiting | Biocodex | 42 | 2024-08-01 | 2024-06-18 |
| Performance and Safety of MUCOGYNE® Ovule as a Moisturizer Mucogyne Ovule - Vaginal Dryness | Not applicable | Terminated | Biocodex | 33 | 2024-04-11 | 2025-04-13 |
| Effects of Probiotic Consumption in Children With Autism Spectrum Disorder (ASD) S. boulardii CNCM (National Collection of Cultures of Microorganisms) I-745 - Autism Spectrum Disorder | Phase 2 | Active not recruiting | Universidad San Francisco de Quito | 66 | 2024-01-06 | 2026-01-15 |
| Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer Mucogyne Gel - Vaginal Dryness | Not applicable | Completed | Biocodex | 34 | 2023-10-10 | 2026-02-19 |
| Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function STIRIPENTOL oral administration - Chronic Renal Insufficiency | Phase 1 | Completed | Biocodex | 39 | 2023-07-24 | 2025-09-05 |
| The Effect of Mucogyne® Gel on Wound Healing Mucogyne® gel - Perineal Tear and Episiotomy | Not applicable | Unknown | Biocodex | 118 | 2023-06-12 | 2024-03-12 |
| Study of Interest of Stiripentol and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies Stiripentol - Pharmacoresistant Focal Epilepsies | Phase 4 | Completed | Biocodex | 52 | 2022-10-13 | 2024-07-24 |
| Retrospective Non-interventional Study of Stiripentol Use in Dravet Patients in the USA Retrospective study - Dravet Syndrome | Completed | Biocodex | 100 | 2022-04-27 | 2024-08-02 | |
| Effect of Ultra-gyn® on Vulvovaginal Candidiasis Ultra-gyn® - Vulvovaginal Candidiasis, Genital | Not applicable | Unknown | Biocodex | 30 | 2022-02-23 | 2022-03-10 |
| Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria stiripentol (Diacomit) - Primary Hyperoxaluria | Phase 2 | Completed | Biocodex | 15 | 2019-05-21 | 2021-03-26 |
| Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers Stiripentol - Healthy Volunteers | Phase 1 | Completed | Biocodex | 14 | 2019-02-12 | 2019-12-20 |
| Efficacy of Bifidobacterium Longum 35624 on the Quality of Life of IBS Patients With Different Symptom Severity Bifidobacterium longum 35624 - Irritable Bowel Syndrome | Completed | Biocodex | 220 | 2018-11-22 | 2021-03-12 | |
| Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children Probiotic : Saccharomyces boulardii, Probiotic : Bacillus clausii - Acute Gastroenteritis | Phase 4 | Completed | Biocodex | 317 | 2017-06-19 | 2019-01-22 |
| Effect of Probiotics on the Fecal Resistome During Helicobacter Pylori Eradication Therapy Saccharomyces Boulardii-Containing Product in Oral Dose Form - Gut Resistome | Phase 4 | Completed | Universidad San Francisco de Quito | 72 | 2016-04-07 | 2021-10-04 |
| Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure intradermal pholcodine allergy test in cases, Blood sampling - Neuromuscular Blocking Agents Anaphylaxis | Not applicable | Unknown | Central Hospital, Nancy, France | 1020 | 2014-07-01 | 2018-12-27 |
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Epilepsies, Myoclonic (2) · Hyperoxaluria, Primary (2) · Irritable Bowel Syndrome (2) · AIDS-Related Complex (1) · Acquired Immunodeficiency Syndrome (1) · Anaphylaxis (1) · Autism Spectrum Disorder (1) · Candidiasis, Vulvovaginal (1) · Diarrhea (1) · Epilepsy (1) · Erythema Chronicum Migrans (1) · Glossitis, Benign Migratory (1) · HIV Infections (1) · Ichthyosis Bullosa of Siemens (1) · Lyme Disease (1)
stiripentol (5) · Amoxicillin (1) · Amoxicillin-Potassium Clavulanate Combination (1) · Blood Specimen Collection (1) · Dosage Forms (1) · Lorazepam (1) · Retrospective Studies (1) · Suspensions (1) · etifoxine (1)
France (11) · United States (3) · Argentina (1) · Belgium (1) · Bulgaria (1) · Ecuador (1) · Mauritius (1) · Pakistan (1) · Portugal (1) · Slovenia (1) · Spain (1)
Ciaran P Kelly, MD (1) · Diyan Genov, MD (1) · Gyasi K Johnson, PhD (1) · Oana Bernard, DR (1) · Surawicz CM (1) · Zaigham Abbas, FACG (1)
PMID 30135030, PMID 30881353, PMID 33295643, PMID 36086703, PMID 36967281, PMID 42643155
2023 (2)