NCT05755308

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
PROCEDURE	Autologous FMT	Autologous faecal microbiota transplantation by colonoscopy.
PROCEDURE	Placebo FMT	Placebo FMT will consist of 250 mL water. Placebo infusions will be delivered by colonoscopy.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-04-01
• Completion: 2026-04-01
• First posted: 2023-03-06
• Last updated: 2023-09-06

Locations

1 site across 1 country: Italy