bifidobacterium infantis

Cell therapyexperimental

Bifidobacterium longum is a Gram-positive, catalase-negative, rod-shaped bacterium present in the human gastrointestinal tract and one of the 32 species that belong to the genus Bifidobacterium. It is a microaerotolerant anaerobe and considered to be one of the earliest colonizers of the gastrointestinal tract of infants. When grown on general anaerobic medium, B. longum forms white, glossy colonies with a convex shape. B. longum is one of the most common bifidobacteria present in the gastrointestinal tracts of both children and adults. B. longum is non-pathogenic, is often added to food products, and its production of lactic acid is believed to prevent growth of pathogenic organisms. — Wikipedia

Clinical trial activity

101 trials · 147 clinical orgs · 0 marketing orgs

Phase 1
12
Phase 2
28
Phase 3
19
Phase 4
13

Earliest trial started Jan 1, 2002 (NCT00510978)

Timeline

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • microbiotaTissue restoration

    microbiota tissue restoration

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • align
  • bifidobacteria infantis
  • bifidobacterium infantis
  • bifidobacterium infantis 35624
  • bifidobacterium infantis r0033
  • bifidobacterium longum bv. infantis
  • bifidobacterium longum infantis
  • bifidobacterium longum ss. infantis r0033
  • bifidobacterium longum ssp infantis r0033
  • bifidobacterium longum subp. infantis r0033
  • b. infantis 35624
  • vsl #3
  • vsl#3

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06452199N/AJun 10, 2024Aarhus University, Gødstrup Hospital, Regionshospitalet Horsens, Statens Serum Institut, Technical University of Denmark, University of Copenhagen
NCT06102213Phase 2Sep 18, 2023Prolacta Bioscience
NCT05923333N/AJul 31, 2023Hoag Memorial Hospital Presbyterian, National Institutes of Health (NIH), Stellenbosch University, University of Cape Town, University of Washington
NCT05952076Phase 3Jul 3, 2023Bill and Melinda Gates Foundation
NCT05703659N/AMar 1, 2023University of Florida
NCT05767450N/ADec 16, 2022Vita-Salute University of Milano. Italy
NCT05129384N/ADec 8, 2021Evolve Biosystems, Inc., Sprim Consulting
NCT04769037N/AApr 22, 2021Gottfried Wilhelm Leibniz Universität Hannover, Helmholtz Centre for Infection Research, Katholieke Universiteit Leuven, Lund University, Medical University of Warsaw, Royal Victoria Infirmary, Newcastle upon Tyne, UK, Technical University of Dresden, Technical University of Munich
NCT04662619N/ADec 18, 2020Evolve Biosystems, Inc., Johnson and Johnson, University of Helsinki
NCT04769687Phase 2Nov 21, 2020University of Franche-Comté
NCT05461833N/ASep 1, 2020Bogomolets National Medical University, Government of Ukraine
NCT04374955N/AJul 31, 2020Halic University, Nobel Pharmaceuticals
NCT04172012Phase 3Mar 1, 2020Arctic University of Norway, Haydom Lutheran Hospital, Muhimbili University, University of Bergen, University of Stavanger
NCT04175392Phase 1/Phase 2 (Phase 2)Dec 1, 2019Oakland University
NCT05146921N/AJul 4, 2019University of London
NCT03994315N/AJun 10, 2019Coastal Pediatric Research, Evolve Biosystems, Inc.
NCT03939546N/AMay 31, 2019Evolve Biosystems, Inc., Orlando Health
NCT03893162N/AMay 31, 2019University of London
NCT04160767Phase 4Jan 30, 2019University of Milan
NCT03666572Phase 2Sep 15, 2018International Center for Diarrheal Disease Research
Showing 20 of 101 trials
Page 1 / 6

Organizations

Research & Development (147)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
VSL PharmaceuticalsFor profit8342004
Evolve Biosystems, Inc.For profit5412018
University of California, DavisAcademic/Hospital5422004
Lallemand SASFor profit4112008
University of LondonAcademic/Hospital4422007
University of MilanAcademic/Hospital4322010
Hebrew UniversityAcademic/Hospital3332004
National Institutes of Health (NIH)Government3032006
Procter and GambleFor profit3222004
Alimentary Health LtdFor profit2122004
All India Institute of Medical SciencesAcademic/Hospital2112007
Bambino Gesù Hospital and Research InstituteAcademic/Hospital2212012
CD Pharma India Pvt. Ltd.For profit2212009
FerringFor profit2022010
Govind Ballabh Pant Institute of Postgraduate Medical Education and ResearchAcademic/Hospital2222008
International Center for Diarrheal Disease ResearchAcademic/Hospital2122013
Johns Hopkins UniversityAcademic/Hospital2022004
National Center for Complementary and Integrative Health (NCCIH)Government2012006
Stanford UniversityAcademic/Hospital2222013
Statens Serum InstitutAcademic/Hospital2012018
147 organizations
Page 1 / 8