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

NCT ID: NCT05755308

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2026-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Faecal microbiota transplantation

Group Type: EXPERIMENTAL

Autologous FMT

Intervention Type: PROCEDURE

Autologous faecal microbiota transplantation by colonoscopy.

Placebo arm

Group Type: PLACEBO_COMPARATOR

Placebo FMT

Intervention Type: PROCEDURE

Placebo FMT will consist of 250 mL water. Placebo infusions will be delivered by colonoscopy.

Interventions

Autologous FMT

Autologous faecal microbiota transplantation by colonoscopy.

Intervention Type: PROCEDURE

Placebo FMT

Placebo FMT will consist of 250 mL water. Placebo infusions will be delivered by colonoscopy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Phase 1 (faecal samples collection)

• Patients aged ≥18 years when signing the informed consent;
• Diagnosis of IPF within 4 weeks based on 2018 ATS/ERS/JRS/ALAT Guidelines (2) as confirmed by the investigator based on chest HRCT scan and if available surgical lung biopsy;
• Patients already on antifibrotic therapy with nintedanib according to clinical practice.

Phase 2 (FMT procedure)

• Patients who develop diarrhea of grade 2 or 3 according to the Common Terminology Criteria (CTC) for Adverse Events (AE) version 5.0 (12) within 8 weeks of baseline visit.

Exclusion Criteria

• Women of childbearing potential or pregnant;
• History of colorectal surgery or cutaneous stoma;
• Food allergies;
• Recent (<6 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antibiotics, probiotics, proton pump inhibitors, immunosuppressants and/or metformin);
• Any documented active or suspected malignancy, except appropriately treated basal cell carcinoma of the skin, "under surveillance" prostate cancer or in situ carcinoma of uterine cervix;
• Decompensated heart failure or heart disease with ejection fraction lower than 30%, severe respiratory failure, psychiatric disorders, pregnancy or inability to provide informed consent.
• Fecal sample unable for FMT according to the opinion of the Investigators (e.g. positive for pathogens);
• (phase 2 only) Diarrhea from known causes (e.g. infectious gastroenteritis, Clostridium difficile infection, coeliac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis and/or biliary salt diarrhea).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

RICHELDI LUCA

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, Roma, Italy

Countries

Italy

Other Identifiers

5260

Identifier Type: -

Identifier Source: org_study_id