Drugs / VSL#3
last change Sep 2025 re-read 9 days ago

VSL#3

Other / unclassified

Developed for
irritable bowel syndrome · cirrhosis of liver · Crohn disease · hepatic encephalopathy · alcoholic liver disease · classic or attenuated familial adenomatous polyposis · esophageal varices · fatty liver disease
+8 more · Hirschsprung disease · NAFLD1 · persian gulf syndrome · portal hypertension · postmenopausal osteoporosis · ulcerative colitis · diarrheal disease · infectious peritonitis
Investigated by
CD Pharma India Pvt. Ltd. · Post Graduate Institute of Medical Education and Research, Chandigarh · University of Alberta · VSL Pharmaceuticals · All India Institute of Medical Sciences · Ashok Tuteja
+26 more · Asian Institute of Gastroenterology, India · Baylor College of Medicine · Beth Israel Deaconess Medical Center · Bill and Melinda Gates Foundation · Canadian Institutes of Health Research (CIHR) · Department of Gastroenterology, Govt. Medical College, Kozhikode, Kerala, India · Dutch Cancer Society · Emory University · Govind Ballabh Pant Hospital · Indian Council of Medical Research · Institute of Liver and Biliary Sciences, India · London North West Healthcare NHS Trust · Ministry of Science and Technology, India · National Institute of Nursing Research (NINR) · Next Gen Pharma India Pvt. Ltd. · Northwell Health · Nottingham University Hospitals NHS Trust · Orphan Australia · Pfizer · Radboud University Medical Center · Tropical Gastroenterology & Nutrition Group (TROPGAN) · United States Department of Defense · University of California, Los Angeles · University of Michigan · University of Washington · University of Wisconsin, Madison

Trials 24

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03682094 Aug 2018 → Jan 2020 — University of Wisconsin, Madison Completed No outcome recorded
Phase 12 trials
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 1/22 trials
Phase 1/2 NCT03511365 May → Dec 2018 NAFLD1 Northwell Health Terminated No outcome recorded
Phase 1/2 NCT01032941 Dec 2009 → Jun 2011 portal hypertension University of Alberta Completed No outcome recorded
Phase 26 trials · 1 missed
Phase 2 NCT05608928 Dec 2022 → May 2023 — Tropical Gastroenterology & Nutrition Group (TROPGAN) Unknown 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 Missed primary
Phase 2 NCT00319007 Apr → Dec 2006 classic or attenuated familial adenomatous polyposis Radboud University Medical Center Unknown No outcome recorded
Phase 2/33 trials · 1 missed
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 Missed primary
Phase 2/3 NCT01008293 Oct 2009 → Jun 2012 hepatic encephalopathy, liver disorder CD Pharma India Pvt. Ltd. Completed No outcome recorded
Phase 33 trials · 1 missed
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 Missed primary
Phase 3 NCT01134692 — cirrhosis of liver, esophageal varices Govind Ballabh Pant Hospital Unknown No outcome recorded
Phase 44 trials
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 applicable3 trials
— NCT05007470 Jan 2022 → Jun 2025 overdue alcoholic liver disease University of California, Los Angeles Active not recruiting No outcome recorded
— NCT01196481 Dec 2012 → Aug 2015 cirrhosis of liver Institute of Liver and Biliary Sciences, India Completed No outcome recorded
— NCT00179582 Jan 2005 → Jan 2006 irritable bowel syndrome Beth Israel Deaconess Medical Center Terminated No outcome recorded Stop: Enrollment
Comparator or background therapy8 trials
Phase 0 NCT01635192 Comparator Dec 2011 → Jul 2013 — Göteborg University Completed No outcome recorded
Phase 1 NCT00932841 Comparator Jan 2008 → Aug 2011 irritable bowel syndrome Dayton Children's Hospital Terminated No outcome recorded
Phase 1/2 NCT00852124 Comparator Feb 2007 → Jan 2013 asthma University of Maryland, Baltimore Terminated No outcome recorded Stop: Enrollment
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

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2024-12-17 Exegi Pharma, LLC Results ExeGi Pharma Positive Topline Results in EXE-346 PROF Phase 1b Study exegipharma.com ↗
ExeGi Pharma LLC, a company focused on developing live biotherapeutic (“LBP”) drugs and probiotics, announced positive topline results in the Phase 1b portion of its PROF study.
2017-05-04 Exegi Pharma, LLC Results Visbiome Probiotic May Play a Role in Recovery of GI Functions in HIV Patients exegipharma.com ↗

All press releases naming this drug 2 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 32 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 ↗

Show 25 more sources

Modality Other / unclassified “Probiotics, living bacteria taken orally” NCT00099723 ↗
Route Oral “Probiotics, living bacteria taken orally” NCT00099723 ↗