Abstract

Microbiota therapeutics for inflammatory bowel disease: the way forward

Lancet Gastroenterol Hepatol. 2024 May;9(5):476-486.doi: 10.1016/S2468-1253(23)00441-7.

 

Lukas Bethlehem 1Maria Manuela Estevinho 2Ari Grinspan 3Fernando Magro 4Jeremiah J Faith 5Jean-Frederic Colombel 6

 
     

Author information

1Department of Genomics and Genetic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

2Department of Gastroenterology, Vila Nova de Gaia Espinho Hospital Center, Vila Nova de Gaia, Portugal; Unit of Pharmacology and Therapeutics, Department of Biomedicine, Faculty of Medicine, University of Porto, Porto, Portugal.

3Dr Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

4Unit of Pharmacology and Therapeutics, Department of Biomedicine, Faculty of Medicine, University of Porto, Porto, Portugal; CINTESIS@RISE, Department of Biomedicine, Faculty of Medicine, University of Porto, Porto, Portugal; Department of Gastroenterology, São João Hospital Center, Porto, Portugal.

5Department of Genomics and Genetic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

6Dr Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: jean-frederic.colombel@mssm.edu.

Abstract

Microbiota therapeutics that transplant faecal material from healthy donors to people with mild-to-moderate ulcerative colitis have shown the potential to induce remission in about 30% of participants in small, phase 2 clinical trials. Despite this substantial achievement, the field needs to leverage the insights gained from these trials and progress towards phase 3 clinical trials and drug approval, while identifying the distinct clinical niche for this new therapeutic modality within inflammatory bowel disease (IBD) therapeutics. We describe the lessons that can be learned from past studies of microbiota therapeutics, from full spectrum donor stool to defined products manufactured in vitro. We explore the actionable insights these lessons provide on the design of near-term studies and future trajectories for the integration of microbiota therapeutics in the treatment of IBD. If successful, microbiota therapeutics will provide a powerful orthogonal approach (complementing or in combination with existing immunomodulatory drugs) to raise the therapeutic ceiling for the many non-responders and partial responders within the IBD patient population.

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