Microbiome - October 2020

Microbiome - October 2020

US FDA granted IND approval for Seed Health’s DS-01 microbiota therapy in Irritable Bowel Syndrome

29 Sep 2020

DS-01 (broad spectrum probiotic) – Seed Health

  • FDA granted new IND approval to Seed Health to evaluate impact of DS-01 probiotic on gut microbiota of patients with Irritable Bowel Syndrome (IBS)
  • Trial details:
    • Phase 2; randomized, triple-blind, placebo-controlled 12 week study; Recruiting; Location: Massachusetts, US; Primary endpoint: Metagenomic stability, metabolic output, quality of life
    • Objective: To assess the impact of DS-01 on both intestinal cells and metabolic output of the native intestinal microbial communities of patients with IBS (IBS-C and IBS-M)

DS-01 granted IND approval, Seed Health recruiting for microbiota therapy in IBS patients

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CI Scientists Remarks: 

  • DS-01 is a broad spectrum probiotic with 24 genetically distinct microorganisms across 12 species
  • This IND approval enables Seed Health to start its Phase 2 clinical trial for DS-01
  • Seed Health is also investigating:
    • Synbiotic (SH-DS01) + ingestible gas sensor to restore gut barrier integrity and gut microbiota composition after antibiotic administration in collaboration with Atmo Biosciences in Canada
    • Synbiotic (PDS-08) to evaluate the tolerability and gastrointestinal response in children (3-17 years) with Constipation in US

– Tarun Raisinghani, CI Scientists

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