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Faecal Microbiota Transplantation to Ameliorate Nintedanib-induced Diarrhea in Patients With Idiopathic Pulmonary Fibrosis
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
114
Start Date
2023-10
Completion Date
2026-04
Last Updated
2023-09-06
Healthy Volunteers
No
Conditions
Interventions
Autologous FMT
Autologous faecal microbiota transplantation by colonoscopy.
Placebo FMT
Placebo FMT will consist of 250 mL water. Placebo infusions will be delivered by colonoscopy.
Locations (1)
Fondazione Policlinico Agostino Gemelli IRCCS
Rome, Roma, Italy