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NOT YET RECRUITING
NCT05755308
NA

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

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, Roma, Italy