The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.

开始日期2023-12-15

申办/合作机构

University of Texas Health Science Center at Houston

NCT04371653 / Withdrawn临床2期IIT

A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Nonalcoholic Fatty Liver Disease (NAFLD)

Potential subjects with non-alcoholic fatty liver disease (NAFLD) will be identified by gastroenterologists (study investigators). Twelve eligible subjects with NAFLD will be randomly assigned to receive either active fecal microbiota transplantation in orally administered capsules or Placebo capsules and dosed twice weekly for 12 weeks. .

开始日期2023-12-01

申办/合作机构

University of Texas Health Science Center at Houston

NCT04373473 / Recruiting临床2期IIT

A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in Combination With Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.

开始日期2020-09-14

申办/合作机构

University of Texas Health Science Center at Houston

100 项与 PRIM-DJ2727 相关的临床结果

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100 项与 PRIM-DJ2727 相关的转化医学

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100 项与 PRIM-DJ2727 相关的专利（医药）

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100 项与 PRIM-DJ2727 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
代谢功能障碍相关的脂肪肝病	临床2期	-	University of Texas Health Science Center at Houston	2023-12-01
艰难梭菌感染	临床2期	美国	University of Texas Health Science Center at Houston	2017-12-21
溃疡性结肠炎	临床1期	美国	University of Texas Health Science Center at Houston	2023-03-27
帕金森病	临床1期	美国	University of Texas Health Science Center at Houston	2019-05-15
HIV感染	临床1期	美国	University of Texas Health Science Center at Houston	2018-04-12

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


MDS2021	N/A	帕金森病	12	PRIM-DJ2727 capsules	遞製構醖構獵壓齋齋鹽(網廠網範鑰夢窪鬱膚蓋) = 鬱膚鏇醖膚糧淵鬱餘鏇選窪餘鏇餘鹹廠繭淵鏇 (遞網鑰糧蓋襯願齋憲膚 ) 更多	-	2021-09-17
NCT03298048 (CTgov)	临床2期	艰难梭菌感染	17	Low fecal microbiota dose (Low Fecal Microbiota Dose)	積顧繭齋觸廠醖選網糧(糧襯蓋願衊鑰齋憲築積) = 艱衊壓鹽構襯廠構願壓壓築簾選願窪廠網鏇鬱 (築鹹範夢襯鹹築襯鹹製, 窪築願網鹹廠築襯製選 ~ 壓製製夢醖繭鑰獵餘顧) 更多	-	2020-03-06
NCT03298048 (CTgov)	临床2期	艰难梭菌感染	17	Mid fecal microbiota dose (Mid Fecal Microbiota Dose)	積顧繭齋觸廠醖選網糧(糧襯蓋願衊鑰齋憲築積) = 窪網鬱選範鬱積餘繭蓋壓築簾選願窪廠網鏇鬱 (築鹹範夢襯鹹築襯鹹製, 製範醖選醖繭願簾選築 ~ 壓遞膚觸夢顧壓鑰艱廠) 更多	-	2020-03-06