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

Idiopathic Pulmonary Fibrosis Clinical Trial

— BIOFEV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05755308
• Other study ID #: 5260
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: April 2026

Study information

• Verified date: September 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: April 2026
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diarrhea
• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Procedure:
• 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

Country	Name	City	State
Italy	Fondazione Policlinico Agostino Gemelli IRCCS	Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Resolution of diarrhea	Resolution of diarrhea at 4 weeks from FMT procedures.	4 weeks
Secondary	Number of Participants with Resolution of diarrhea	Resolution of diarrhea at 1 and 12 weeks from FMT procedures	1 and 12 weeks
Secondary	Nintedanib discontinuation	Rate of nintedanib discontinuation or dose reduction	12 weeks
Secondary	Intestinal microbiota composition	Analysis of intestinal microbiota composition at baseline and at 1, 4 and 12 weeks after the end of FMT procedures	1, 4 and 12 weeks
Secondary	Forced vital capacity (FVC)	Relative and absolute change in forced vital capacity (FVC) percent-predicted from baseline at week 12	12 weeks
Secondary	St. George's Respiratory Questionnaire (SGRQ)	Change in St. George's Respiratory Questionnaire (SGRQ) score from baseline at week 12	12 weeks
Secondary	Exacerbation	Time to first acute exacerbation.	12 weeks