Clinical trial • Phase III • Other
Fecal microbiota transplantation for Irritable bowel syndrome | Clostridioides difficile infection
Phase III trial of Fecal microbiota transplantation for Irritable bowel syndrome | Clostridioides difficile infection. 25 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Irritable bowel syndrome | Clostridioides difficile infection
- Trial Stage
- Phase III
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 08-10-2024
- First CTIS Authorization Date
- 21-10-2024
Trial design
Phase III trial across 1 site in Finland.
- Target Sample Size
- 25
Eligibility
Recruits 25 Vulnerable population selected; no details provided on consent or assent handling in the available documents..
- Vulnerable Population
- Vulnerable population selected; no details provided on consent or assent handling in the available documents.
Recruitment
- Planned Sample Size
- 25
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 25
Finland
- Earliest CTIS Part Ii Submission Date
- 23-09-2024
- Latest Decision Or Authorization Date
- 21-10-2024
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 25
Sites
- Site Name
- HUS-Yhtymae
- Department Name
- HUS Diagnostic Center, Clinical Pharmacology
- Contact Person Name
- Janne Backman
- Contact Person Email
- janne.backman@hus.fi
Sponsor
Primary sponsor
- Full Name
- HUS-Yhtymae
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- Fecal microbiota transplantation
- Modality
- Other
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