Idiopathic Pulmonary FibrosisBIOFEVNCT05755308
Faecal Microbiota Transplantation to Ameliorate Nintedanib-induced Diarrhea in Patients With Idiopathic Pulmonary Fibrosis
A study testing Autologous FMT in people with Idiopathic Pulmonary Fibrosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Autologous FMT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2023to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicentric, randomised, double-blind, placebo-controlled study that will consist of two consecutive phases:
- First phase: faecal samples will be collected in patients diagnosed with Idiopathic pulmonary fibrosis treated with nintedanib.
- 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
- Being tested
- Autologous FMT, Placebo FMT
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous FMTProcedure or surgery
Autologous faecal microbiota transplantation by colonoscopy.
Placebo FMTProcedure or surgery
Placebo FMT will consist of 250 mL water. Placebo infusions will be delivered by colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Faecal microbiota transplantation | Experimental | Not described Receives: Procedure: Autologous FMT |
| Placebo arm | Placebo comparator | Not described Receives: Procedure: Placebo FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Resolution of diarrhea
Resolution of diarrhea at 4 weeks from FMT procedures.
Measured: 4 weeks
Secondary outcomes (6)
Number of Participants with Resolution of diarrhea
Resolution of diarrhea at 1 and 12 weeks from FMT procedures
Measured: 1 and 12 weeks
Nintedanib discontinuation
Rate of nintedanib discontinuation or dose reduction
Measured: 12 weeks
Intestinal microbiota composition
Analysis of intestinal microbiota composition at baseline and at 1, 4 and 12 weeks after the end of FMT procedures
Measured: 1, 4 and 12 weeks
Forced vital capacity (FVC)
Relative and absolute change in forced vital capacity (FVC) percent-predicted from baseline at week 12
Measured: 12 weeks
St. George's Respiratory Questionnaire (SGRQ)
Change in St. George's Respiratory Questionnaire (SGRQ) score from baseline at week 12
Measured: 12 weeks
Exacerbation
Time to first acute exacerbation.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study startOct 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RICHELDI LUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755308
- Sponsor's protocol ID
- 5260
- Acronym
- BIOFEV
- Status last verified
- Sep 2023
- First submitted
- 23 Feb 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation to Ameliorate Nintedanib-induced Diarrhea in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT05755308
- Acronym / sponsor ID
- BIOFEV / 5260
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentric, randomised, double-blind, placebo-controlled study that will consist of two consecutive phases:
- First phase: faecal samples will be collected in patients diagnosed with Idiopathic pulmonary fibrosis treated with nintedanib.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faecal microbiota transplantation | Experimental | Procedure: Autologous FMT |
| Placebo arm | Placebo comparator | Procedure: Placebo FMT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous FMTAutologous faecal microbiota transplantation by colonoscopy. | Procedure or surgery | Faecal microbiota transplantation |
| Placebo FMTPlacebo FMT will consist of 250 mL water. Placebo infusions will be delivered by colonoscopy. | Procedure or surgery | Placebo arm |
Primary outcome
Number of Participants with Resolution of diarrhea
Time frame: 4 weeks
Resolution of diarrhea at 4 weeks from FMT procedures.
6 secondary outcomes
Number of Participants with Resolution of diarrhea
Time frame: 1 and 12 weeks
Nintedanib discontinuation
Time frame: 12 weeks
Intestinal microbiota composition
Time frame: 1, 4 and 12 weeks
Forced vital capacity (FVC)
Time frame: 12 weeks
St. George's Respiratory Questionnaire (SGRQ)
Time frame: 12 weeks
Exacerbation
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous FMT in people with Idiopathic Pulmonary Fibrosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Resolution of diarrhea (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.