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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
114
Autologous faecal microbiota transplantation by colonoscopy.
Placebo FMT will consist of 250 mL water. Placebo infusions will be delivered by colonoscopy.
Fondazione Policlinico Agostino Gemelli IRCCS
Rome, Roma, Italy
Number of Participants with Resolution of diarrhea
Resolution of diarrhea at 4 weeks from FMT procedures.
Time frame: 4 weeks
Number of Participants with Resolution of diarrhea
Resolution of diarrhea at 1 and 12 weeks from FMT procedures
Time frame: 1 and 12 weeks
Nintedanib discontinuation
Rate of nintedanib discontinuation or dose reduction
Time frame: 12 weeks
Intestinal microbiota composition
Analysis of intestinal microbiota composition at baseline and at 1, 4 and 12 weeks after the end of FMT procedures
Time frame: 1, 4 and 12 weeks
Forced vital capacity (FVC)
Relative and absolute change in forced vital capacity (FVC) percent-predicted from baseline at week 12
Time frame: 12 weeks
St. George's Respiratory Questionnaire (SGRQ)
Change in St. George's Respiratory Questionnaire (SGRQ) score from baseline at week 12
Time frame: 12 weeks
Exacerbation
Time to first acute exacerbation.
Time frame: 12 weeks
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