bifidobacterium breve
Cell therapyexperimental
Bifidobacterium breve is a bacterial species of the genus Bifidobacterium which has probiotic properties. Bifidobacteria are a type of bacteria that live symbiotically in the intestines of humans. They have been used to treat a number of conditions including constipation, diarrhea, irritable bowel syndrome and even the cold and flu. Some of these uses have been backed up by scientific research, but others have not. B.breve also shows a stronger affinity for immature bowels than other species evidencing in its strong capabilities as a probiotic. — Wikipedia
Clinical trial activity
90 trials · 122 clinical orgs · 0 marketing orgs
Phase 1
10
Phase 2
20
Phase 3
12
Phase 4
15
Earliest trial started Dec 1, 2003 (NCT00175292)
Timeline
Indications
Approved for
Studied for
- Acute-On-Chronic Liver Failure · Phase 2/Phase 3
- Adenomatous Polyposis Coli · Phase 2
- Aged · Early Phase 1
- Ascites · Phase 2
- Asthma · Phase 1/Phase 2
- Bifidobacterium breve · Phase 4
- Celiac Disease · Phase 4
- Cognitive Dysfunction · Phase 4
- Colic · Phase 4
- Crohn Disease · Phase 4
- Deglutition Disorders · Early Phase 1
- Diabetes Mellitus · Phase 2
- Diarrhea · Phase 4
- Drug Resistance, Bacterial · Phase 2
- Fatty Liver · Phase 1
- Fibrosis · Phase 4
- Gastrointestinal Microbiome · Phase 4
- General Surgery · Phase 3
- Healthy Volunteers · Early Phase 1
- Hepatic Encephalopathy · Phase 4
- Hirschsprung Disease · Phase 2
- Hypersensitivity · Phase 4
- Inflammation · Phase 2
- Inflammatory Bowel Diseases · Phase 3
- Interleukin-17 · Phase 1/Phase 2
- Intestinal Neoplasms · Early Phase 1
- Irritable Bowel Syndrome · Phase 4
- Kidney Failure, Chronic · Phase 2
- Klebsiella pneumoniae · Phase 1/Phase 2
- Liver Cirrhosis · Phase 2/Phase 3
- Neonatal Sepsis · Phase 3
- Non-alcoholic Fatty Liver Disease · Phase 1/Phase 2
- Osteoporosis · Phase 2
- Pediatric Obesity · Phase 4
- Peritonitis · Phase 2/Phase 3
- Probiotics · Phase 4
- Scleroderma, Systemic · Phase 2
Mechanism of action
- microbiotaTissue restoration
microbiota tissue restoration
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaBifidobacterium breve ↗
Also known as
- bif195
- bifidobacterium breve
- vsl #3
- vsl#3
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07234448 | N/A | Dec 1, 2025 | Liaquat University of Medical & Health Sciences, University of Urbino "Carlo Bo" |
| NCT07082062 | N/A | Jun 2, 2025 | Chung Shan Medical University, TCI Co., Ltd. |
| NCT06850714 | N/A | Feb 23, 2025 | Liaquat University of Medical & Health Sciences, University of Insubria |
| NCT06720805 | N/A | Dec 1, 2024 | University of Roma La Sapienza |
| NCT06148714 | N/A | Dec 1, 2023 | Citruslabs, Maneuver Marketing |
| NCT05767450 | N/A | Dec 16, 2022 | Vita-Salute University of Milano. Italy |
| NCT05614726 | N/A | Jun 18, 2021 | Biohm Health, LLC, The Center for Applied Health Sciences, LLC |
| NCT04842149 | N/A | May 21, 2021 | Chr Hansen, University of Copenhagen |
| NCT04808271 | N/A | Apr 16, 2021 | Chr Hansen, University of Copenhagen |
| NCT04769687 | Phase 2 | Nov 21, 2020 | University of Franche-Comté |
| NCT05461833 | N/A | Sep 1, 2020 | Bogomolets National Medical University, Government of Ukraine |
| NCT04677738 | N/A | Aug 30, 2020 | KGK Science Inc., Morinaga Milk Industry Co. Ltd., Japan |
| NCT04374955 | N/A | Jul 31, 2020 | Halic University, Nobel Pharmaceuticals |
| NCT04447924 | N/A | Jun 22, 2020 | Chr Hansen, Methodist Cancer Center, Houston, Texas |
| NCT04448847 | N/A | Jun 8, 2020 | Chr Hansen, University of Copenhagen |
| NCT04172012 | Phase 3 | Mar 1, 2020 | Arctic University of Norway, Haydom Lutheran Hospital, Muhimbili University, University of Bergen, University of Stavanger |
| NCT04065503 | Early Phase 1 (Phase 1) | Sep 30, 2019 | Lallemand SAS, University of Florida |
| NCT03910322 | N/A | Aug 1, 2019 | Atlantia Food Clinical Trials, Chr Hansen, Methodist Cancer Center, Houston, Texas |
| NCT05146921 | N/A | Jul 4, 2019 | University of London |
| NCT03893162 | N/A | May 31, 2019 | University of London |
Showing 20 of 90 trials
Page 1 / 5
Organizations
Research & Development (122)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| VSL Pharmaceuticals | For profit | 8 | 3 | 4 | 2004 |
| Chr Hansen | For profit | 6 | 4 | 1 | 2017 |
| University of Copenhagen | Academic/Hospital | 4 | 3 | 1 | 2018 |
| University of London | Academic/Hospital | 4 | 4 | 2 | 2007 |
| University of Milan | Academic/Hospital | 4 | 3 | 2 | 2010 |
| Hebrew University | Academic/Hospital | 3 | 3 | 3 | 2004 |
| University of Roma La Sapienza | Academic/Hospital | 3 | 2 | 1 | 2014 |
| All India Institute of Medical Sciences | Academic/Hospital | 2 | 1 | 1 | 2007 |
| Atlantia Food Clinical Trials | For profit | 2 | 0 | 1 | 2017 |
| Bambino Gesù Hospital and Research Institute | Academic/Hospital | 2 | 2 | 1 | 2012 |
| Biosearch S.A. | For profit | 2 | 2 | 2 | 2011 |
| CD Pharma India Pvt. Ltd. | For profit | 2 | 2 | 1 | 2009 |
| Ferring | For profit | 2 | 0 | 2 | 2010 |
| Lallemand SAS | For profit | 2 | 0 | 2 | 2015 |
| Liaquat University of Medical & Health Sciences | Academic/Hospital | 2 | 2 | 1 | 2025 |
| Methodist Cancer Center, Houston, Texas | Academic/Hospital | 2 | 0 | 1 | 2019 |
| University of Alberta | Academic/Hospital | 2 | 1 | 2 | 2003 |
| University of Calgary | Academic/Hospital | 2 | 2 | 2 | 2017 |
| University of Eastern Piedmont | Academic/Hospital | 2 | 2 | 1 | 2013 |
| University of Florida | Academic/Hospital | 2 | 2 | 2 | 2015 |
122 organizations
Page 1 / 7