Studies
| Study First Submitted Date | 2021-06-27 |
| Study First Posted Date | 2021-07-13 |
| Last Update Posted Date | 2023-05-19 |
| Start Month Year | November 1, 2023 |
| Primary Completion Month Year | December 1, 2024 |
| Verification Month Year | May 2023 |
| Verification Date | 2023-05-31 |
| Last Update Posted Date | 2023-05-19 |
Detailed Descriptions
| Sequence: | 20765188 |
| Description | The treatment of recurrent CDI is still a burden on the healthcare system. FMT is highly effective for the treatment of recurrent CDI, resulting in the resolution of CDI up to 100% of the cases. FMT also has a good short-term safety profile, however long-term events like transfer of multiresistant bacteria and other living microorganism is still a major problem. On the other hand, the fecal filtrate contains only bacterial debris, proteins, and antimicrobial compounds and not intact microorganisms. The FILTRATE trial is a multicenter, two-arm randomized controlled trial, and aims to compare the safety and efficacy of fecal filtrate transplantation to conventional fecal microbiota transplantation (FMT) in the treatment of recurrent CDI. Adult patients with multiple recurrent (>1) CDIs will be randomized 1:1 to receive either FMT or fecal filtrate transplantation. The transplantation will be carried out using lyophilized capsule on each arm. The primary endpoint of the study will be the clinical resolution of CDI-associated diarrhea 8 weeks after the interventions. Questionnaires will be completed on enrollment and at the time of each follow-up. Adverse events will be recorded and reported to the relevant institutional and national ethics committee. After the intervention, a one-year follow-up is also planned. Blood and stool samples will be collected at baseline and at each follow-up. |
Facilities
| Sequence: | 200477472 |
| Name | Institute for Translational Medicine, University of Pécs |
| City | Pécs |
| Zip | 7624 |
| Country | Hungary |
Facility Contacts
| Sequence: | 28161171 |
| Facility Id | 200477472 |
| Contact Type | primary |
| Name | Péter Hegyi, MD,PhD, Dsc |
| p.hegyi@tm-centre.org | |
Conditions
| Sequence: | 52283207 | Sequence: | 52283208 |
| Name | Clostridium Difficile Infection | Name | Recurrent Clostridium Difficile Infection |
| Downcase Name | clostridium difficile infection | Downcase Name | recurrent clostridium difficile infection |
Id Information
| Sequence: | 40239537 |
| Id Source | org_study_id |
| Id Value | 30700-5/2021/EÜIG |
Countries
| Sequence: | 42657717 |
| Name | Hungary |
| Removed | False |
Design Groups
| Sequence: | 55718157 | Sequence: | 55718158 |
| Group Type | Active Comparator | Group Type | Active Comparator |
| Title | Fecal filtrate transplantation | Title | Conventional fecal microbiota transplantation |
| Description | Patients randomized to the fecal filtrate transplantation group | Description | Patients randomized to the conventional fecal microbiota transplantation group |
Interventions
| Sequence: | 52595270 | Sequence: | 52595271 |
| Intervention Type | Biological | Intervention Type | Biological |
| Name | Fecal filtrate transplantation | Name | Conventional fecal microbiota transplantation |
| Description | Patients will receive 5-8 encapsulated lyophilized fecal filtrate transplantations in enterosolvent, size "0" capsules. Before intervention patients will receive proton pump inhibitors and prokinetics. After the preparation, the participants will be instructed to swallow the capsules one by one within 5 minutes with fluid to help to swallow the capsules. | Description | Patients will receive 5-8 encapsulated lyophilized conventional fecal microbiota transplantations in enterosolvent, size "0" capsules. Before intervention patients will receive proton pump inhibitors and prokinetics. After the preparation, the participants will be instructed to swallow the capsules one by one within 5 minutes with fluid to help to swallow the capsules. |
Keywords
| Sequence: | 80027016 | Sequence: | 80027017 | Sequence: | 80027018 |
| Name | fecal microbiota transplantation | Name | fecal filtrate | Name | recurrent infection |
| Downcase Name | fecal microbiota transplantation | Downcase Name | fecal filtrate | Downcase Name | recurrent infection |
Design Outcomes
| Sequence: | 177791106 | Sequence: | 177791107 | Sequence: | 177791108 | Sequence: | 177791109 | Sequence: | 177791110 | Sequence: | 177791111 | Sequence: | 177791112 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Resolution of diarrhea | Measure | Resolution of diarrhea | Measure | Recurrence of CDI symptoms | Measure | Overall mortality | Measure | Disease associated mortality | Measure | Adverse events | Measure | Change of the intestinal microbiome |
| Time Frame | 8 weeks | Time Frame | 1 year | Time Frame | 8 weeks, 1 year | Time Frame | 8 weeks, 1 year | Time Frame | 8 weeks, 1 year | Time Frame | 8 weeks, 1 year | Time Frame | 8 weeks, 1 year |
| Description | Clinical resolution of the CDI associated diarrhea, defined by 2 or less stools (Bristol 1-4) per day in two consecutive days. The rate of the outcome will be compared within groups. | Description | Clinical resolution of the CDI associated diarrhea, defined by 2 or less stools (Bristol 1-4) per day in two consecutive days. The rate of the outcome will be compared within groups. | Description | Recurrence of the CDI symptoms (diarrhea, abdominal pain ect.) within 8 weeks after an initial amelioration. The rate of the outcome will be compared within groups. | Description | Overall mortality. The rate of the outcome will be compared within groups. | Description | Disease-associated mortality. The rate of the outcome will be compared within groups. | Description | Proportion of adverse events (AE) and serious adverse events (SAE). The rate of the outcome will be compared within groups. | Description | Change of the intestinal microbiome at the end of the follow up period regarding to the initial intestinal microbiome. The rate of the outcome will be compared within groups. |
Browse Conditions
| Sequence: | 193915144 | Sequence: | 193915145 | Sequence: | 193915146 | Sequence: | 193915147 | Sequence: | 193915148 | Sequence: | 193915149 | Sequence: | 193915150 | Sequence: | 193915151 | Sequence: | 193915152 |
| Mesh Term | Infections | Mesh Term | Communicable Diseases | Mesh Term | Clostridium Infections | Mesh Term | Recurrence | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Gram-Positive Bacterial Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses |
| Downcase Mesh Term | infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | clostridium infections | Downcase Mesh Term | recurrence | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | gram-positive bacterial infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48424056 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | University of Pecs |
Central Contacts
| Sequence: | 12036001 |
| Contact Type | primary |
| Name | Péter Hegyi, MD,PhD, Dsc |
| Phone | +3672/536-246 |
| p.hegyi@tm-centre.org | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68300265 | Sequence: | 68300266 |
| Design Group Id | 55718157 | Design Group Id | 55718158 |
| Intervention Id | 52595270 | Intervention Id | 52595271 |
Eligibilities
| Sequence: | 30830389 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: age ≥18 years multiple recurrent CDI (≥2 previous episodes of CDI) at least 3 or more loose or watery stools (Bristol 5-7) per day a positive Glutamate Dehydrogenase (GDH)-enzyme and positive CDI toxin A and/or B test the patient or the legal guardian sign the written informed consent Exclusion Criteria: pregnancy or breastfeeding ongoing antibiotic treatment fulminant CDI previous FMT immunodeficiency need of intensive care requirement for vasoactive drugs other cause of diarrhea inflammatory bowel diseases irritable bowel syndrome life expectancy shorter than 3 months unavailable for follow-up visits |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254132464 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 6 |
Designs
| Sequence: | 30576310 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Triple |
| Subject Masked | True |
| Caregiver Masked | True |
| Outcomes Assessor Masked | True |
Links
| Sequence: | 4396929 |
| Url | https://tm-centre.org/en/research/ |
| Description | Related info |
Responsible Parties
| Sequence: | 28942720 |
| Responsible Party Type | Principal Investigator |
| Name | Dr Hegyi Péter |
| Title | Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs |
| Affiliation | University of Pecs |
Study References
| Sequence: | 52183223 | Sequence: | 52183224 | Sequence: | 52183225 |
| Pmid | 34150673 | Pmid | 33106983 | Pmid | 24762631 |
| Reference Type | result | Reference Type | result | Reference Type | result |
| Citation | Varga A, Kocsis B, Sipos D, Kasa P, Vigvari S, Pal S, Dembrovszky F, Farkas K, Peterfi Z. How to Apply FMT More Effectively, Conveniently and Flexible – A Comparison of FMT Methods. Front Cell Infect Microbiol. 2021 Jun 4;11:657320. doi: 10.3389/fcimb.2021.657320. eCollection 2021. | Citation | Dembrovszky F, Gede N, Szakacs Z, Hegyi P, Kiss S, Farkas N, Molnar Z, Imrei M, Dohos D, Peterfi Z. Fecal Microbiota Transplantation May Be the Best Option in Treating Multiple Clostridioides difficile Infection: A Network Meta-Analysis. Infect Dis Ther. 2021 Mar;10(1):201-211. doi: 10.1007/s40121-020-00356-9. Epub 2020 Oct 26. | Citation | Youngster I, Sauk J, Pindar C, Wilson RG, Kaplan JL, Smith MB, Alm EJ, Gevers D, Russell GH, Hohmann EL. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study. Clin Infect Dis. 2014 Jun;58(11):1515-22. doi: 10.1093/cid/ciu135. Epub 2014 Apr 23. |