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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05755308
Collaborator
(none)
114
1
2
36
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Autologous FMT
  • Procedure: Placebo FMT
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Faecal Microbiota Transplantation to Ameliorate Nintedanib-induced Diarrhea in Patients With Idiopathic Pulmonary Fibrosis
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Faecal microbiota transplantation

Procedure: Autologous FMT
Autologous faecal microbiota transplantation by colonoscopy.

Placebo Comparator: Placebo arm

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

Outcome Measures

Primary Outcome Measures

  1. Resolution of diarrhea [4 weeks]

    Resolution of diarrhea at 4 weeks from FMT procedures.

Secondary Outcome Measures

  1. Resolution of diarrhea [1 and 12 weeks]

    Resolution of diarrhea at 1 and 12 weeks from FMT procedures

  2. Nintedanib discontinuation [12 weeks]

    Rate of nintedanib discontinuation or dose reduction

  3. Intestinal microbiota composition [1, 4 and 12 weeks]

    Analysis of intestinal microbiota composition at baseline and at 1, 4 and 12 weeks after the end of FMT procedures

  4. Forced vital capacity (FVC) [12 weeks]

    Relative and absolute change in forced vital capacity (FVC) percent-predicted from baseline at week 12

  5. St. George's Respiratory Questionnaire (SGRQ) [12 weeks]

    Change in St. George's Respiratory Questionnaire (SGRQ) score from baseline at week 12

  6. Exacerbation [12 weeks]

    Time to first acute exacerbation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondazione Policlinico Agostino Gemelli IRCCS Rome Roma Italy 00168

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RICHELDI LUCA, Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05755308
Other Study ID Numbers:
  • 5260
First Posted:
Mar 6, 2023
Last Update Posted:
Mar 6, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 6, 2023