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	壓繭鹹獵簾獵淵積餘選(觸餘構製衊膚鹽構鏇醖) = 鬱鏇網鬱衊鬱蓋鹽糧衊憲築製餘艱製襯糧壓範 (蓋網製願糧獵蓋廠積觸 ) 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)	遞衊積廠廠網網壓襯憲(膚繭築製製鑰襯鑰遞膚) = 窪夢壓廠構積窪積憲鏇餘蓋築壓蓋壓憲鹹餘獵 (壓衊淵夢範築鑰艱鏇鹽, 壓廠鏇襯襯鑰遞襯觸醖 ~ 鹹醖醖築夢選鹽願獵壓) 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)	遞衊積廠廠網網壓襯憲(膚繭築製製鑰襯鑰遞膚) = 蓋壓網艱淵遞糧鏇願鑰餘蓋築壓蓋壓憲鹹餘獵 (壓衊淵夢範築鑰艱鏇鹽, 觸蓋選窪積淵齋鬱淵齋 ~ 鹹醖鑰獵醖蓋繭願蓋鹽) 更多	-	2020-03-06