炎症性肠病
溃疡性结肠炎
临床试验
医学
肠道菌群
药品
人口
疾病
重症监护医学
免疫学
内科学
药理学
环境卫生
作者
Lukas Bethlehem,María Manuela Estevinho,Ari Grinspan,Fernando Magro,Jeremiah J. Faith,Jean‐Frédéric Colombel
标识
DOI:10.1016/s2468-1253(23)00441-7
摘要
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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