PF-AtlasClinical Trials › NCT05755308

Faecal Microbiota Transplantation to Ameliorate Nintedanib-induced Diarrhea in Patients With Idiopathic Pulmonary Fibrosis

Autologous FMT · Not specified

Registry ID
NCT05755308
Phase
Not specified
Status
Unknown
Drug / intervention
Autologous FMT
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Start
2023-10
Enrollment
114
Locations
1

About this trial

This is a multicentric, randomised, double-blind, placebo-controlled study that will consist of two consecutive phases: 1. First phase: faecal samples will be collected in patients diagnosed with Idiopathic pulmonary fibrosis treated with nintedanib. 2. Second phase: double-blind, randomised, clinical trial of autologous faecal microbiota transplantation (FMT) vs placebo in Idiopathic pulmonary fibrosis patients who will experience nintedanib-induced diarrhea within 8 weeks of baseline visit. Follow-up visits will be scheduled at 1, 4 and 12 weeks after randomization. The main aim of the study is to assess the efficacy of FMT in ameliorating diarrhea experienced by patients with idiopathic pulmonary fibrosis treated with nintedanib.

View NCT05755308 on ClinicalTrials.gov →

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Medical disclaimer. This page summarizes public trial data for NCT05755308 for information only. It is not medical advice, an endorsement, or an offer to enroll. Confirm details on ClinicalTrials.gov and with a qualified physician.