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| ID | Type | Description | Link |
|---|---|---|---|
| TYH2025304 | Other Grant/Funding Number | Finnish state research funding |
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Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.
The aim of the study is to investigate the efficacy and safety of fecal capsules in the treatment of recurrent Clostridioides difficile infection in a double-blind RCT. The study will also investigate whether stool antigen testing or accurate clinical information on risk factors can identify patients who would benefit most from fecal transplantation. The study will include 76 patients who have had recurrent Clostridioides difficile infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving active treatment | Experimental | CDI patients receiving healthy donor stool by capsules |
|
| Placebo arm | Placebo Comparator | Placebo FMT capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy donor stool | Biological | Healthy donor stool given by capsules produced by the same method as in Copenhagen University Hospital |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with recurrence of Clostridioides difficile infection (rCDI), defined as positive fecal Clostridioides difficile nucleinic acid measurement and diarrhea after Fecal Microbiota transplantation (FMT) within 12 weeks after FMT. | The investigators compare the number of patients with rCDI in different groups (placebo vs active FMT group) evaluated by Clostridioides difficile nucleinic acid measurement. | The investigators evaluate the number of patietns who get rCDI within 12 weeks after FMT (Placebo or active FMT). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with side effects after FMT capsules. | Number of patients with side effects after FMT capsules. Number of Safety of FMT capsules is recorded by contacting the patient by phone call after 1 week and by answering the questionnaire after 1, 4 and 12 weeks after FMT (placebo or active FMT). Questionnaire includes information about any symptoms or signs possible related to recurrecy of CDI, such as fever (defined the temperature over 38 degrees), and diarrhea (defindes as more tahn three loose stool per day). Rate of side effects will be expressed by percentage of the patients. |
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Inclusion Criteria:
At least twice recurrent CDI*
Patient has had CDI-related diarrhea during infections (3 or more Bristol Stool Form Scale type 6-7 stools)
Other causes of diarrhea have been excluded based on clinical data
Age over 18 years
Remission of symptoms during antibiotic course (metronidazole, vancomycin or fidaxomicin)
No other antibiotic courses
Able to sign the consent form or accept it electronically via Suomi.fi identification
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Perttu Arkkila, Professor | Contact | +358504272272 | +35894711 | perttu.arkkila@hus.fi |
| Suvi Niku, PhD, MD | Contact | +35840 7579938 | +35894711 | suvi.niku@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Perttu Arkkila, Professor | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Recruiting | Helsinki | Uusimaa | 00290 | Finland |
The investigators have no plan to share IPD
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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|
| placebo capsule | Biological | Copenhagen University Hvidrovre Hospital method for capsule production |
|
|
| One, four and twelve weeks after FMT (placebo or active FMT). |