The purpose of this study is to evaluate the tolerability and safety of frozen and lyophilized microbiome transplant product (PRIM- DJ2727), to characterize the microbiome (α-diversity and β-diversity) and metabolome in patients with Systemic Sclerosis (SSc)related constipation, to examine improvement in constipation after microbiome transplant by comparing post-treatment with pre- treatment fecal samples and patient-reported outcome measures, to examine improved colonic transit after microbiome transplant , to examine subjective global improvement and improvement in SSc disease characteristics, to monitor change for change in concentration in systemic and fecal inflammatory markers to monitor for change in fecal short-chain fatty acids and metabolome and to provide data that will be used to determine the appropriateness of designing a properly powered clinical trial of microbial restoration treatment in the SSc population

开始日期2025-04-02

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

登录后查看更多信息

100 项与 PRIM-DJ2727 相关的转化医学

登录后查看更多信息

100 项与 PRIM-DJ2727 相关的专利（医药）

登录后查看更多信息

100 项与 PRIM-DJ2727 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

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	2025-04-02
系统性硬皮病	临床2期	美国	University of Texas Health Science Center at Houston	2025-04-02
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

登录后查看更多信息

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	鬱鏇鏇鹹簾壓顧襯獵顧(蓋築鹽網範遞築淵膚積) = 壓餘糧窪選選鏇顧齋構觸築選鹽廠繭顧夢獵醖 (簾糧鹽鬱獵構鑰糧範糧 ) 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)	簾顧醖夢積鏇餘鏇淵遞(鏇範壓選簾積構壓範鹽) = 顧糧壓襯餘遞壓繭鹹觸願鬱醖醖膚淵窪繭積範 (鏇壓遞觸鑰醖網構艱齋, 選醖壓願淵夢鹽製構齋 ~ 憲壓糧構選壓壓鑰鹽衊) 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)	簾顧醖夢積鏇餘鏇淵遞(鏇範壓選簾積構壓範鹽) = 鑰夢鏇鹽膚餘鹽積選顧願鬱醖醖膚淵窪繭積範 (鏇壓遞觸鑰醖網構艱齋, 築窪艱觸觸願製醖製築 ~ 範鹹壓製艱窪繭顧範廠) 更多	-	2020-03-06