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This is a multicentric, randomised, double-blind, placebo-controlled study that will consist of two consecutive phases:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Faecal microbiota transplantation | Experimental |
| |
| Placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous FMT | Procedure | Autologous faecal microbiota transplantation by colonoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Resolution of diarrhea | Resolution of diarrhea at 4 weeks from FMT procedures. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Resolution of diarrhea | Resolution of diarrhea at 1 and 12 weeks from FMT procedures | 1 and 12 weeks |
| Nintedanib discontinuation | Rate of nintedanib discontinuation or dose reduction |
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Inclusion Criteria:
Phase 1 (faecal samples collection)
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Agostino Gemelli IRCCS | Rome | Roma | 00168 | Italy |
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| Placebo FMT | Procedure | Placebo FMT will consist of 250 mL water. Placebo infusions will be delivered by colonoscopy. |
|
| 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 | 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 | 12 weeks |
| St. George's Respiratory Questionnaire (SGRQ) | Change in St. George's Respiratory Questionnaire (SGRQ) score from baseline at week 12 | 12 weeks |
| Exacerbation | Time to first acute exacerbation. | 12 weeks |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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