PRIM-DJ2727(PRIM-DJ2727) - 在研适应症：便秘，系统性硬皮病，溃疡性结肠炎_专利_临床

概要

基本信息

药物类型

粪菌移植

别名-

靶点-

作用方式

调节剂

作用机制

细菌替代物、微生物调节剂

治疗领域

免疫系统疾病消化系统疾病皮肤和肌肉骨骼疾病+ [1]

在研适应症

便秘系统性硬皮病溃疡性结肠炎

非在研适应症

艰难梭菌感染HIV感染代谢功能障碍相关的脂肪肝病+ [1]

原研机构

University of Texas Health Science Center at Houston

在研机构

University of Texas Health Science Center at Houston

非在研机构-

权益机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

10

项与 PRIM-DJ2727 相关的临床试验

NCT06827977

/ Recruiting临床2期IIT

A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis

The purpose of this study is to characterize the intestinal flora in subjects with systemic sclerosis-related constipation and/or significant bloating and to determine safety and trends in improvements in the diversity of colonic microbiome and patient symptoms following the administration of either frozen or lyophilized PRIM-DJ2727 microbiota.

开始日期2025-03-03

申办/合作机构

University of Texas Health Science Center at Houston

NCT05786404

/ Recruiting临床1期IIT

A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis

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

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
便秘	临床2期	美国	University of Texas Health Science Center at Houston	2025-03-03
系统性硬皮病	临床2期	美国	University of Texas Health Science Center at Houston	2025-03-03
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
溃疡性结肠炎	临床2期	美国	University of Texas Health Science Center at Houston	2020-09-14
艰难梭菌感染	临床2期	美国	University of Texas Health Science Center at Houston	2017-12-21
帕金森病	临床2期	-	University of Texas Health Science Center at Houston	2017-07-15
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

查看全部结果

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	艱鑰鏇襯夢繭艱範製構(製顧窪醖壓淵鑰齋構鹽) = 製製蓋蓋鬱餘構醖積壓積齋襯鏇糧艱製鹹遞製 (築醖築齋鏇廠襯獵夢餘 ) 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)	製淵餘築觸憲顧齋壓窪 = 構窪網繭醖鬱憲廠鏇廠範製範廠獵範鏇顧艱鏇 (鬱窪網獵顧製網範繭網, 顧願構廠網憲製構積鹽 ~ 範觸鏇築繭鬱糧觸廠膚) 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)	製淵餘築觸憲顧齋壓窪 = 鏇製糧艱窪選膚餘遞觸範製範廠獵範鏇顧艱鏇 (鬱窪網獵顧製網範繭網, 憲艱夢齋鹽餘鬱壓醖網 ~ 觸網廠糧鏇願鑰鏇艱範) 更多	-	2020-03-06