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Not yet recruitingNCT05755308BIOFEVUpdated Sep 6, 2023

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

An interventional study of Autologous FMT and Placebo FMT in Idiopathic Pulmonary Fibrosis, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis
03

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's planned enrollment of 114 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
114 participants (estimated)

Study arms

  • Experimental
    Faecal microbiota transplantation

    Procedure: Autologous FMT

  • Placebo comparator
    Placebo arm

    Procedure: Placebo FMT

Interventions

  • ProcedureAutologous FMT

    Autologous faecal microbiota transplantation by colonoscopy.

  • ProcedurePlacebo FMT

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

06

What researchers measure

Primary outcomes

  1. Number of Participants with Resolution of diarrhea

    Resolution of diarrhea at 4 weeks from FMT procedures.

    Time frame: 4 weeks

Secondary outcomes

  1. Number of Participants with Resolution of diarrhea

    Resolution of diarrhea at 1 and 12 weeks from FMT procedures

    Time frame: 1 and 12 weeks

  2. Nintedanib discontinuation

    Rate of nintedanib discontinuation or dose reduction

    Time frame: 12 weeks

  3. Intestinal microbiota composition

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

    Time frame: 1, 4 and 12 weeks

  4. Forced vital capacity (FVC)

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

    Time frame: 12 weeks

  5. St. George's Respiratory Questionnaire (SGRQ)

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

    Time frame: 12 weeks

  6. Exacerbation

    Time to first acute exacerbation.

    Time frame: 12 weeks

07

Study locations

1 site
  • Fondazione Policlinico Agostino Gemelli IRCCS
    Rome, Roma 00168, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05755308
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
RICHELDI LUCA (Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Mar 6, 2023
Start date
Oct 2023 (estimated)
Primary completion
Apr 2024 (estimated)
Completion
Apr 2026 (estimated)
Last update
Sep 6, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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