Drugs / VSL#3
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VSL#3

Other / unclassified

Developed for
irritable bowel syndrome · cirrhosis of liver · Crohn disease · atopic eczema · hepatic encephalopathy · acute diarrhea · alcoholic liver disease · Alzheimer disease
+33 more · asthma · classic or attenuated familial adenomatous polyposis · constipation disorder · dental caries · esophageal varices · fatty liver disease · food allergy · group B streptococcal infection · hematopoietic and lymphoid cell neoplasm · Hirschsprung disease · HIV infectious disease · immune dysregulation, neurodevelopmental defects, and colitis · lichen planus, oral · mixed anxiety and depressive disorder · NAFLD1 · perennial allergic rhinitis · periodontitis · persian gulf syndrome · portal hypertension · postmenopausal osteoporosis · primary dysmenorrhea · rheumatoid arthritis · Sjogren syndrome · squamous cell intraepithelial neoplasia · ulcerative colitis · urinary system disorder · diarrheal disease · epilepsy · hyperbilirubinemia · infectious peritonitis · necrotizing enterocolitis · psoriasis · Rotavirus infection
Investigated by
CD Pharma India Pvt. Ltd. · Post Graduate Institute of Medical Education and Research, Chandigarh · Rise Therapeutics LLC · University of Alberta · University of Wisconsin, Madison · VSL Pharmaceuticals
+62 more · AIDS Healthcare Foundation · All India Institute of Medical Sciences · Ashok Tuteja · Asian Institute of Gastroenterology, India · B-Crobes Marketing(M) Sdn Bhd · Baylor College of Medicine · Beth Israel Deaconess Medical Center · Bill and Melinda Gates Foundation · BioGaia AB · Biosearch S.A. · Canadian Institutes of Health Research (CIHR) · Cukurova University · Department of Gastroenterology, Govt. Medical College, Kozhikode, Kerala, India · Duke University · Dutch Cancer Society · Emanual Maverakis, MD · Emory University · Exegi Pharma, LLC · Faculty of Medicine, University of Indonesia · Federico García García, PhD · First Affiliated Hospital of Harbin Medical University · Flinders Medical Center · Flinders University · Govind Ballabh Pant Hospital · HIV Immunotherapeutics Institute · Indian Council of Medical Research · Institute of Liver and Biliary Sciences, India · International Flavors & Fragrances Inc. · London North West Healthcare NHS Trust · Ministry of Science and Technology, India · Moon (Guangzhou) Biotechnology Co., Ltd. · National Cancer Institute (NCI) · National Institute of Nursing Research (NINR) · National Institute on Aging (NIA) · National University of Malaysia · Next Gen Pharma India Pvt. Ltd. · Northwell Health · Norwegian University of Science and Technology · Nottingham University Hospitals NHS Trust · Orphan Australia · Pfizer · Phramongkutklao College of Medicine and Hospital · Prolacta Bioscience · Radboud University Medical Center · Sharda University · South Australian Health and Medical Research Institute · St. Olavs Hospital · Sunstar, Inc. · The Baruch Padeh Medical Center, Poriya · The University of Western Australia · Tine · Tropical Gastroenterology & Nutrition Group (TROPGAN) · United States Agency for International Development (USAID) · United States Department of Defense · Universitaire Ziekenhuizen KU Leuven · University of California, Los Angeles · University of California, San Francisco · University of Michigan · University of Sao Paulo · University of Washington · Women's & Children's Hospital Foundation · Women's and Children's Hospital, Adelaide

Trials 45 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT03682094 Aug 2018 → Jan 2020 University of Wisconsin, Madison Completed No outcome recorded
Phase 0 NCT03574051 May 2018 → May 2020 First Affiliated Hospital of Harbin Medical University Unknown No outcome recorded
Phase 17 trials
Phase 1 NCT06297213 Jun 2026 → Aug 2028 expected Sjogren syndrome Rise Therapeutics LLC Not yet recruiting No outcome recorded
Phase 1 NCT07234227 Jun 2026 → Nov 2027 expected urinary system disorder Duke University Not yet recruiting No outcome recorded
Phase 1 NCT05961592 Oct 2023 → Nov 2026 expected rheumatoid arthritis Rise Therapeutics LLC Recruiting No outcome recorded
Phase 1 NCT04165551 Oct 2019 → Sep 2020 group B streptococcal infection Biosearch S.A. Unknown No outcome recorded
Phase 1 NCT02286999 Oct 2015 → Jan 2018 atopic eczema, food allergy Emanual Maverakis, MD Withdrawn No outcome recorded
Phase 1 NCT00971711 Sep 2009 → Dec 2013 irritable bowel syndrome Baylor College of Medicine Completed No outcome recorded
Phase 1 NCT00099723 Oct 2004 → Dec 2005 fatty liver disease VSL Pharmaceuticals Terminated No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT04119011 Oct 2019 → Mar 2020 primary dysmenorrhea National University of Malaysia Completed No outcome recorded
Phase 1/2 NCT03511365 May → Dec 2018 NAFLD1 Northwell Health Terminated No outcome recorded
Phase 1/2 NCT03399903 May 2017 → Mar 2019 HIV infectious disease, colitis AIDS Healthcare Foundation Completed No outcome recorded
Phase 1/2 NCT01032941 Dec 2009 → Jun 2011 portal hypertension University of Alberta Completed No outcome recorded
Phase 211 trials
Phase 2 NCT06949800 Sep 2026 → May 2027 expected human papillomavirus-related squamous cell carcinoma, squamous cell intraepithelial neoplasia University of California, San Francisco Not yet recruiting No outcome recorded
Phase 2 NCT07413744 Aug 2026 → Mar 2029 expected Alzheimer disease University of Wisconsin, Madison Not yet recruiting No outcome recorded
Phase 2 NCT07189390 May 2026 → May 2029 expected immune dysregulation, neurodevelopmental defects, and colitis South Australian Health and Medical Research Institute Recruiting No outcome recorded
Phase 2 NCT06102213 Sep 2023 → Aug 2024 hematopoietic and lymphoid cell neoplasm Prolacta Bioscience Terminated No outcome recorded
Phase 2 NCT05608928 Dec 2022 → May 2023 Tropical Gastroenterology & Nutrition Group (TROPGAN) Unknown No outcome recorded
Phase 2 NCT03386643 Nov 2017 → Apr 2018 lichen planus, oral University of Sao Paulo Completed No outcome recorded
Phase 2 NCT03165747 Oct 2017 → Mar 2019 postmenopausal osteoporosis Emory University Terminated No outcome recorded
Phase 2 NCT01701297 Feb 2012 → Oct 2014 cirrhosis of liver Nottingham University Hospitals NHS Trust Terminated No outcome recorded
Phase 2 NCT01465802 Dec 2011 → May 2015 non-small cell lung carcinoma Pfizer Completed No outcome recorded
Phase 2 NCT00630838 Sep 2006 → Sep 2010 Hirschsprung disease University of Michigan Completed No outcome recorded
Phase 2/35 trials
Phase 2/3 NCT03829358 Feb → Jul 2018 constipation disorder Faculty of Medicine, University of Indonesia Completed No outcome recorded
Phase 2/3 NCT02752594 Apr 2015 dental caries Sharda University Completed No outcome recorded
Phase 2/3 NCT03078530 Sep 2013 → May 2018 persian gulf syndrome Ashok Tuteja Unknown No outcome recorded
Phase 2/3 NCT01110447 Apr 2010 → Mar 2013 hepatic encephalopathy CD Pharma India Pvt. Ltd. Completed No outcome recorded
Phase 2/3 NCT01008293 Oct 2009 → Jun 2012 hepatic encephalopathy, liver disorder CD Pharma India Pvt. Ltd. Completed No outcome recorded
Phase 33 trials
Phase 3 NCT02545413 May 2016 → Jun 2017 irritable bowel syndrome Next Gen Pharma India Pvt. Ltd. Withdrawn No outcome recorded
Phase 3 NCT00175292 Dec 2003 → ? Crohn disease University of Alberta Completed No outcome recorded
Phase 3 NCT01134692 cirrhosis of liver, esophageal varices Govind Ballabh Pant Hospital Unknown No outcome recorded
Phase 45 trials
Phase 4 NCT01765998 Feb 2013 → Feb 2014 Crohn disease The Baruch Padeh Medical Center, Poriya Unknown No outcome recorded
Phase 4 NCT01638208 Aug → Dec 2012 irritable bowel syndrome Asian Institute of Gastroenterology, India Unknown No outcome recorded
Phase 4 NCT01479660 Mar 2011 → Oct 2014 ulcerative colitis Post Graduate Institute of Medical Education and Research, Chandigarh Unknown No outcome recorded
Phase 4 NCT00418340 Dec 2007 → ? irritable bowel syndrome London North West Healthcare NHS Trust Unknown No outcome recorded
Phase 4 NCT00114465 Jun 2005 → Dec 2008 Crohn disease Orphan Australia Completed No outcome recorded
Phase not applicable8 trials
NCT07331987 Jun → Dec 2026 expected mixed anxiety and depressive disorder Moon (Guangzhou) Biotechnology Co., Ltd. Recruiting No outcome recorded
NCT05548361 Apr 2022 → Dec 2024 periodontitis Cukurova University Completed No outcome recorded
NCT05007470 Jan 2022 → Jun 2025 overdue alcoholic liver disease University of California, Los Angeles Active not recruiting No outcome recorded
NCT02736994 Apr → Sep 2014 Universitaire Ziekenhuizen KU Leuven Completed No outcome recorded
NCT01196481 Dec 2012 → Aug 2015 cirrhosis of liver Institute of Liver and Biliary Sciences, India Completed No outcome recorded
NCT01273012 Apr 2010 → Aug 2011 acute diarrhea Phramongkutklao College of Medicine and Hospital Unknown No outcome recorded
NCT00179582 Jan 2005 → Jan 2006 irritable bowel syndrome Beth Israel Deaconess Medical Center Terminated No outcome recorded
NCT00159523 Dec 2003 → Sep 2007 asthma, atopic eczema, perennial allergic rhinitis Norwegian University of Science and Technology Completed No outcome recorded
Also used as a comparator or background therapy in 13 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT01635192 Comparator Dec 2011 → Jul 2013 Göteborg University Completed No outcome recorded
Phase 11 trial
Phase 1 NCT00932841 Comparator Jan 2008 → Aug 2011 irritable bowel syndrome Dayton Children's Hospital Terminated No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT05254249 Comparator Feb → Aug 2022 psoriasis Dr. Soetomo General Hospital Unknown No outcome recorded
Phase 1/2 NCT00852124 Comparator Feb 2007 → Jan 2013 asthma University of Maryland, Baltimore Terminated No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT02011542 Comparator Sep 2013 → Jul 2016 persian gulf syndrome University of Utah Terminated No outcome recorded
Phase 2/3 NCT00973908 Comparator Apr 2010 → Apr 2012 diarrheal disease National Health Service, United Kingdom Completed No outcome recorded
Phase 2/3 NCT00678613 Comparator Jul 2007 → ? cirrhosis of liver, infectious peritonitis All India Institute of Medical Sciences Unknown No outcome recorded
Phase 31 trial
Phase 3 NCT03266913 Comparator Aug → Oct 2017 hyperbilirubinemia Hormozgan University of Medical Sciences Unknown No outcome recorded
Phase 43 trials
Phase 4 NCT05160350 Comparator Apr → Oct 2021 epilepsy Mazandaran University of Medical Sciences Completed No outcome recorded
Phase 4 NCT01632462 Comparator Sep 2012 → Dec 2014 Crohn disease Federico II University Unknown No outcome recorded
Phase 4 NCT01178372 Comparator Sep 2008 → Sep 2010 hepatic encephalopathy Govind Ballabh Pant Hospital Unknown No outcome recorded
Phase not applicable2 trials
NCT07233382 Comparator Dec 2025 → May 2026 overdue necrotizing enterocolitis Hayatabad Medical Complex Not yet recruiting No outcome recorded
NCT00683982 Comparator Aug 2007 → May 2008 Rotavirus infection, diarrheal disease Centro Pediatrico Albina de Patino Completed No outcome recorded

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 60 sources stand behind the page.

FieldValueCited text
Known as VSL #3 “VSL#3 is a commercial probiotic mixture consisting of eight probiotic lactic acid bacteria and Bifidobacteria including Lactobacillus acidophilus, Lactobacillus plantarum,...” NCT05608928
35

“The probiotic VSL #3 is easily available, cheap, effective and safe alternative or substitute for the existing therapeutic agents will be evaluated in this study for their...” NCT01479660

“This will be a double blind randomized placebo controlled study to determine the clinical efficacy of 12 weeks of oral probiotics (VSL#3) in patients with inflammatory bowel disease.” NCT01479660

“Patients will be randomised to receive either VSL#3 (450 billion lyophilized bacteria/sachet) twice daily for 4 weeks or a placebo powder containing starch but no bacteria.” NCT00418340

“The probiotic product VSL#3® comes in a powder (sachet) that is to be dissolved in half a glass of cold water before ingestion.” NCT01635192

“Patients will receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.” NCT00973908

“Adults with IBS were randomized into an open label trial to receive the probiotic VSL#3 for 4 or 8 weeks.” PMID 35295488 Sep 2021

“Patients in this group will be given the probiotic VSL#3 2 packets BID for a total of 8 weeks.” NCT01032941

“VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks” NCT01465802

“VSL#3 is a commercial probiotic mixture consisting of eight bacterial strains:” NCT05007470

VSL #3 (probiotic mixture) is given to this group” NCT02011542

“The Probiotics used in this study will be VSL#3.” NCT00678613

NCT01701297

NCT00932841

NCT00114465

NCT00099723

NCT01196481

NCT01632462

NCT02011542

NCT00179582

NCT00630838

NCT02545413

NCT00175292

NCT00852124

NCT00973908

NCT03682094

NCT01635192

NCT01008293

NCT00319007

NCT03165747

NCT03078530

NCT01638208

NCT01134692

NCT01110447

NCT01178372

NCT03511365

Known as Align ClinicalTrials.gov intervention name — accepted as the source's own label NCT03399903
Known as B. infantis ClinicalTrials.gov intervention name — accepted as the source's own label NCT02286999
1

NCT06102213

Known as Bifidobacterium animalis subsp. lactis HN019 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03386643
Known as Bifidobacterium longum subsp. infantis “Herein we propose a novel phase I ascending dose trial of Bifidobacterium longum subsp. infantis (B. infantis) to identify the dose required to produce predominant gut...” PMID 27449926 Jul 2016
Known as EXE-346 Probiotic ClinicalTrials.gov intervention name — accepted as the source's own label NCT06949800
Known as Infloran “Probiotic Infloran® Hard capsules” NCT07189390
1

NCT01273012

Known as L. acidophilus La-5 “In a randomized, double-blind trial, women received probiotic milk or placebo from 36 weeks of gestation up to 3 months postnatally while breast-feeding. The probiotic milk...” PMID 25782657 Aug 2015
Known as Lactobacillus crispatus probiotic ClinicalTrials.gov intervention name — accepted as the source's own label NCT07234227
Known as Lactobacillus Plantarum IS-10506 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05254249
1

NCT03829358

Known as PIP toothbrush cleaner (Chrisal, Lommel, Belgium). ClinicalTrials.gov intervention name — accepted as the source's own label NCT02736994
Known as Probiotic “Drug: ProbioticNCT03266913
11

NCT07233382

NCT03574051

NCT01765998

NCT05160350

NCT00159523

NCT02752594

NCT07331987

NCT04119011

NCT07413744

NCT05548361

NCT04165551

Known as Probiotic mix preparation ClinicalTrials.gov intervention name — accepted as the source's own label NCT00683982
Known as R-2487 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06297213
1

NCT05961592

Action Inhibit “the ability of a battery of Lactobacillus strains to inhibit the growth of S. agalactiae” NCT04165551
Modality Other / unclassified “Probiotics, living bacteria taken orally” NCT00099723
Route Oral “Probiotics, living bacteria taken orally” NCT00099723