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INTESTIFIX 001

DRUG6 trials

Sponsors

Klinikum Der Universitat Munchen AöR, Universitaetsklinikum Heidelberg AöR, Universitaetsklinikum Aachen AöR, Goethe University Frankfurt, Fraunhofer Institute For Translational Medicine And Pharmacology ITMP

Conditions

Crohn's diseaseHepatocellular carcinomaInfections with multidrug-resistant EnterobacteriaceaeIntestinal colonization with vancomycin-resistant enterococci (VRE)Recurrent urinary tract infections (rUTI)cirrhosis and ascites

Phase 1

Phase 2

Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab – A randomized, placebo-controlled, double-blind Phase II trial (FLORA)
RecruitingCTIS2023-506887-15-00
Universitaetsklinikum Heidelberg AöRHepatocellular carcinoma
Start: 2025-07-14Target: 48Updated: 2026-01-22
Encapsulated Fecal Microbiota Transfer to Treat Immune Activation in Patients with Cirrhosis and Ascites (TransImmune) – A randomized, double-blind, placebo-controlled phase IIa clinical pilot study
RecruitingCTIS2023-507790-18-00
Universitaetsklinikum Aachen AöRcirrhosis and ascites
Start: 2025-08-01Target: 24Updated: 2026-01-12
A Randomized controlled open-label phase II trial assessing the efficacy and safety of two-dosing regimens of frozen encapsulated fecal microbiota transfer products with or without an individualized donor selection approach in decolonizing carriers of multi-drug resistant Enterobacteriaceae (RESET-MDR)
RecruitingCTIS2024-519748-34-00
Goethe University FrankfurtInfections with multidrug-resistant Enterobacteriaceae
Start: 2026-01-23Target: 76Updated: 2025-10-09
Fecal microbiota transfer for the secondary prevention of recurrent urinary tract infections in premenopausal women: a phase II trial (FEMITRANS)
Not yet recruitingCTIS2025-520452-28-00
Goethe University FrankfurtRecurrent urinary tract infections (rUTI)
Target: 24Updated: 2026-01-07
Randomized Controlled Trial Assessing the Effectiveness and Safety of Fecal Microbiota Transfer for VRE Eradication in Immunocompromised Patients (EU CTR, Phase II) – VRE-ex
Not yet recruitingCTIS2026-525632-41-00
Fraunhofer Institute For Translational Medicine And Pharmacology ITMPIntestinal colonization with vancomycin-resistant enterococci (VRE)
Target: 42Updated: 2026-07-21

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