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.

Start Date15 Dec 2023

Sponsor / Collaborator

University of Texas Health Science Center at Houston

NCT04371653 / WithdrawnPhase 2IIT

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. .

Start Date01 Dec 2023

Sponsor / Collaborator

University of Texas Health Science Center at Houston

NCT04373473 / RecruitingPhase 2IIT

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.

Start Date14 Sep 2020

Sponsor / Collaborator

University of Texas Health Science Center at Houston

100 Clinical Results associated with PRIM-DJ2727

100 Translational Medicine associated with PRIM-DJ2727

100 Patents (Medical) associated with PRIM-DJ2727

100 Deals associated with PRIM-DJ2727

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 1	US	University of Texas Health Science Center at Houston	27 Mar 2023
Metabolic dysfunction-associated steatotic liver disease	Discovery	-	University of Texas Health Science Center at Houston	01 Dec 2023
Parkinson Disease	Discovery	US	University of Texas Health Science Center at Houston	15 May 2019
HIV Infections	Discovery	US	University of Texas Health Science Center at Houston	12 Apr 2018
Clostridium difficile infection	Discovery	US	University of Texas Health Science Center at Houston	21 Dec 2017

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


MDS2021	Not Applicable	Parkinson Disease	12	PRIM-DJ2727 capsules	apxgynruzl(hrfekbowdq) = zerdzkecys nskwzyzaib (szevftlsnr ) View more	-	17 Sep 2021
NCT03298048 (CTgov)	Phase 2	Clostridium difficile infection	17	Low fecal microbiota dose (Low Fecal Microbiota Dose)	hlwusvutsr(dlbxvmwlqy) = xvbvylxjsb zlvsxzbjjj (jhlyfspsii, qdblkvxkix - ggyiuwlvok) View more	-	06 Mar 2020
NCT03298048 (CTgov)	Phase 2	Clostridium difficile infection	17	Mid fecal microbiota dose (Mid Fecal Microbiota Dose)	hlwusvutsr(dlbxvmwlqy) = ayvyuyvmyz zlvsxzbjjj (jhlyfspsii, curkzhiabn - lnsdcomria) View more	-	06 Mar 2020

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