NCT05755308

Brief Summary

This is a multicentric, randomised, double-blind, placebo-controlled study that will consist of two consecutive phases:

  1. 1.First phase: faecal samples will be collected in patients diagnosed with Idiopathic pulmonary fibrosis treated with nintedanib.
  2. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

February 23, 2023

Last Update Submit

September 1, 2023

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Resolution of diarrhea

    Resolution of diarrhea at 4 weeks from FMT procedures.

    4 weeks

Secondary Outcomes (6)

  • Number of Participants with Resolution of diarrhea

    1 and 12 weeks

  • Nintedanib discontinuation

    12 weeks

  • Intestinal microbiota composition

    1, 4 and 12 weeks

  • Forced vital capacity (FVC)

    12 weeks

  • St. George's Respiratory Questionnaire (SGRQ)

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Faecal microbiota transplantation

EXPERIMENTAL
Procedure: Autologous FMT

Placebo arm

PLACEBO COMPARATOR
Procedure: Placebo FMT

Interventions

Autologous FMTPROCEDURE

Autologous faecal microbiota transplantation by colonoscopy.

Faecal microbiota transplantation
Placebo FMTPROCEDURE

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

Placebo arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, Roma, 00168, Italy

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 6, 2023

Study Start

October 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2026

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations

IT(1)